paolo mannelli - Academia.edu (original) (raw)

Papers by paolo mannelli

Research paper thumbnail of The high prevalence of substance use disorders among recent MDMA users compared with other drug users: Implications for intervention

Addictive Behaviors, Aug 1, 2009

Aim-In light of the resurgence in MDMA use and its association with polysubstance use, we investi... more Aim-In light of the resurgence in MDMA use and its association with polysubstance use, we investigated the 12-month prevalence of substance use disorders (SUDs) among adult MDMA users to determine whether they are at risk of other drug-related problems that would call for targeted interventions. Methods-Data were drawn from the 2006 National Survey on Drug Use and Health. Past-year adult drug users were grouped into three mutually exclusive categories: 1) recent MDMA users, who had used the drug within the past year; 2) former MDMA users, who had a history of using this drug but had not done so within the past year; and 3) other drug users, who had never used MDMA. Logistic regression procedures were used to estimate the association between respondents' SUDs and MDMA use while adjusting for their socioeconomic status, mental health, age of first use, and history of polydrug use. Results-Approximately 14% of adults reported drug use in the past year, and 24% of those pastyear drug users reported a history of MDMA use. Recent MDMA users exhibited the highest prevalence of disorders related to alcohol (41%), marijuana (30%), cocaine (10%), pain reliever/ opioid (8%), and tranquilizer (3%) use. Adjusted logistic regression analyses revealed that, relative to other drug users, those who had recently used MDMA were twice as likely to meet criteria for marijuana and pain reliever/opioid use disorders. They were also about twice as likely as former MDMA users to meet criteria for marijuana, cocaine, and tranquilizer use disorders. Conclusions-Seven out of ten recent MDMA users report experiencing an SUD in the past year. Adults who have recently used MDMA should be screened for possible SUDs to ensure early detection and treatment.

Research paper thumbnail of Adjuvant Trazodone in the Treatment of Alcoholism: An Open Study

Alcohol and Alcoholism, Jul 1, 1998

Serotonergic drugs have been proven to be helpful to alcoholics in maintaining abstinence. In thi... more Serotonergic drugs have been proven to be helpful to alcoholics in maintaining abstinence. In this open study, we report that the atypical antidepressant trazodone at low doses was able to significandy decrease craving for alcohol, depressive, and anxious symptoms in a number (25) of detoxified alcohol-dependent subjects after 3 months of treatment. Trazodone may, therefore, be an adjuvant in the therapy of alcoholism.

Research paper thumbnail of Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness

Nicotine & Tobacco Research, Oct 31, 2019

Introduction: High rates of tobacco use among people with serious mental illness (SMI), along wit... more Introduction: High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population. Methods: In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16. Results: Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = .010). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions. Conclusions: This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI. Implications: This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.

Research paper thumbnail of A Randomized, Double-blind, Placebo-controlled Trial of Augmentation With an Extended Release Formulation of Methylphenidate in Outpatients With Treatment-Resistant Depression

Journal of Clinical Psychopharmacology, Dec 1, 2006

We examined the efficacy and tolerability of augmentation with an extended release formulation of... more We examined the efficacy and tolerability of augmentation with an extended release formulation of methylphenidate (OROS MPH, Concerta) in patients with major depression who were nonresponders or partial responders to antidepressants. Sixty subjects with treatment-resistant depression (TRD) participated in a 4-week, randomized, double-blind, placebo-controlled study of augmentation with methylphenidate (18-54 mg/d). The preexisting antidepressant dose was unchanged. The primary efficacy measure was change in the 21-item Hamilton Depression Rating Scale from randomization to end of treatment. Data were analyzed with intent-to-treat with last observation carried forward approach. There were no statistically significant differences between the methylphenidate (n = 30) and placebo (n = 30) groups in reduction in 21-item Hamilton Depression Rating Scale scores (drug, -6.9; placebo, -4.7) from baseline to end of treatment (F1,47 = 1.24, P = 0.22), although responders were numerically higher in the extended-release methylphenidate group (40.0%) than in the placebo group (23.3%). On the secondary efficacy measures of changes in Clinical Global Impression-Improvement and Severity scores and Beck Depression Inventory-Second Edition, the drug failed to separate from placebo, although the proportion of responders in the drug group were numerically higher than placebo. There were no significant differences in weight, heart rate, and blood pressure changes between the 2 groups. The common adverse events were loss of appetite, nausea, headache, and anxiety. The mean dose of drug was 34.2 mg/d. The study did not demonstrate a statistically significant benefit for augmentation with methylphenidate in TRD. Combination of methylphenidate with antidepressants was well tolerated. Adequately powered, randomized, controlled trials are necessary to fully evaluate the efficacy of extended-release methylphenidate in TRD.

Research paper thumbnail of Erratum to: Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Dependence and Serious Mental Illness

Nicotine & Tobacco Research, Aug 6, 2020

Research paper thumbnail of Emergency therapeutical approach simulating ultrarapid opioid detoxification in methadone withdrawal precipitated by erroneous administration of naltrexone

European Journal of Emergency Medicine, Jun 1, 1999

Research paper thumbnail of Patient perspectives on community pharmacy administered and dispensing of methadone treatment for opioid use disorder: a qualitative study in the U.S

Addiction Science & Clinical Practice, Aug 2, 2023

Background Pharmacy administration and dispensing of methadone treatment for opioid use disorder ... more Background Pharmacy administration and dispensing of methadone treatment for opioid use disorder (PADMOUD) may address inadequate capability of opioid treatment programs (OTPs) in the US by expanding access to methadone at community pharmacies nationally. PADMOUD is vastly underutilized in the US. There is no published US study on OUD patients' perspectives on PADMOUD. Data are timely and needed to inform the implementation of PAD-MOUD in the US to address its serious opioid overdose crisis. Methods Patient participants of the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were interviewed to explore implementation-related factors for PADMOUD. All 20 participants of the parent study were invited to participate in this interview study. Each interview was recorded and transcribed verbatim. Thematic analysis was conducted to identify emergent themes. Results Seventeen participants completed the interview. Patients' perspectives on PADMOUD were grouped into five areas. Participants reported feasibility of taking the tablet formulation of methadone at the pharmacy and identified benefits from PADMOUD (e.g., better access, efficiency, convenience) compared with usual care at the OTP. Participants perceived support for PADMOUD from their family/friends, OTP staff, and pharmacy staff. PADMOUD was perceived to be a great option for stable patients with take-home doses and those with transportation barriers. The distance (convenience), office hours, and the cost were considered factors most influencing their decision to receive methadone from a pharmacy. Nonjudgmental communication, pharmacists' training on methadone treatment, selection of patients (stable status), workflow of PADMOUD, and protection of privacy were considered key factors for improving operations of PADMOUD. Conclusion This study presents the first findings on patient perspectives on PADMOUD. Participants considered pharmacies more accessible than OTPs, which could encourage more people to receive methadone treatment earlier and help transition stable patients from an OTP into a local pharmacy. The findings have timely implications for informing implementation strategies of PADMOUD that consider patients' views and needs.

Research paper thumbnail of The opioid overdose epidemic: opportunities for pharmacists

Substance Abuse and Rehabilitation, Jul 1, 2017

Research paper thumbnail of Pregnant Mothers With Substance Use Problems and Their Treatment in North Carolina

North Carolina medical journal, Jan 10, 2023

Research paper thumbnail of Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended‐Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens

American Journal on Addictions, Apr 4, 2020

Background and Objective: When patients seek to discontinue buprenorphine (BUP) treatment, monthl... more Background and Objective: When patients seek to discontinue buprenorphine (BUP) treatment, monthly injectable extendedrelease naltrexone (XR-NTX) may help them avoid relapse. The efficacy of low ascending doses of oral NTX vs placebo for patients transitioning from BUP to XR-NTX is evaluated in this study. Methods: In a phase 3, hybrid residential/outpatient study, clinically stable participants with opioid use disorder (N = 101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment, were randomized (1:1) to 7 residential days of descending doses of BUP and low ascending doses of oral NTX (NTX/BUP, n = 50) or placebo (PBO-N/BUP, n = 51). Both groups received standing ancillary medications and psychoeducational counseling. Following negative naloxone challenge, participants received XR-NTX (day 8). The primary endpoint was the proportion of participants who received and tolerated XR-NTX. Results: There was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407). The mean number of days with peak Clinical Opiate Withdrawal Scale (COWS) score less than or equal to 12 during the treatment period (days 1-7) was similar for NTX/BUP and PBO-N/BUP groups (5.8 vs 6.3; P = .511). Opioid withdrawal symptoms during XR-NTX induction and post-XR-NTX observation period (days 8-11) were mild and similar between groups (mean peak COWS score: NTX/BUP, 5.1 vs PBO-N/BUP, 5.4; P = .464). Adverse events were mostly mild/moderate. Conclusions and Scientific Significance: Low ascending doses of oral NTX did not increase induction rates onto XR-NTX compared with placebo. The overall rate of successful induction across treatment groups supports a brief BUP taper with standing ancillary medications as a well-tolerated approach for patients seeking transition from BUP to XR-NTX.

Research paper thumbnail of Review of Popularity and Quality Standards of Opioid-Related Smartphone Apps

Current Addiction Reports, Nov 10, 2020

Purpose of review:Opioid misuse, addiction, and related harm is a global crisis that affects publ... more Purpose of review:Opioid misuse, addiction, and related harm is a global crisis that affects public health and social and economic welfare. Many of the strategies being used to combat the opioid crisis could benefit from improved access and dissemination, such as that afforded by smartphone apps. The goal of this study was to characterize the purpose, audience, quality and popularity of opioid-related smartphone apps. Using web scraping, available information from 619 opioid-related apps (e.g., popularity metrics) was downloaded from Google Play, and 59 apps met criteria for review. The apps were additionally coded for quality by two raters using an 8-item screener for the American Psychiatric Association App Evaluation Model.Findings:Sixty one percent of apps targeted patients, 29% providers, 8% the general community, and 2% healthcare trainees. Regarding app purpose, 49% addressed treatment, 27% prevention, and 24% overdose. Only one app met all criteria on the screener for quality, and there was no association between a total score calculated for the screener and measures of app popularity (e.g., star ratings; R2=0.10, p=0.19).Summary:Opioid-related apps available for consumers addressed key stakeholders (patients, providers, community) and were consistent with strategies to address the opioid crisis (prevention, treatment, overdose). However, there was little evidence that available opioid-related apps meet basic quality standards, and no relationship was found between app quality and popularity. This review was conducted at the level of consumer decision-making (i.e., the app store), where only a handful of opioid-related apps met quality standards enough to warrant a more detailed evaluation of the app before recommendation for use. Because smartphone apps could be a critical tool to increase access to and utilization of opioid prevention, treatment, and recovery services, further development and testing is sorely needed.

Research paper thumbnail of New Pharmacological Targets for the Treatment of Excessive Alcohol use

Current drug research reviews, Nov 1, 2022

Research paper thumbnail of Meet Our Co-Editor-in-Chief

Current drug research reviews, Feb 26, 2019

Research paper thumbnail of Feasibility of very low dose naltrexone and buprenorphine transition from opioid use to extended-release naltrexone

Drug and Alcohol Dependence, 2015

Research paper thumbnail of Heroin Use in Older Adults: A Treatment Challenge

American Journal of Geriatric Psychiatry, May 1, 2021

Research paper thumbnail of Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone

The American Journal of Drug and Alcohol Abuse, 2021

ABSTRACT Background Pharmacologic treatment is recommended for many individuals with opioid use d... more ABSTRACT Background Pharmacologic treatment is recommended for many individuals with opioid use disorder (OUD). For patients who select opioid antagonist treatment, effective management of opioid withdrawal symptoms during transition to antagonist treatment requires consideration of the patient experience. Objectives To compare patterns of opioid withdrawal between those withdrawing from untreated opioid use and those withdrawing from buprenorphine. Methods We performed a post hoc, cross-study comparison of the temporal pattern of opioid withdrawal during 1-week induction onto extended-release naltrexone by similar protocols enrolling two participant populations: participants with OUD entering a study with untreated opioid use (N = 378, NCT02537574) or on stable buprenorphine (BUP) treatment (N = 101, NCT02696434). Results The temporal pattern of withdrawal from induction day 1 through day 7 differed between the two participant populations for Clinical Opiate Withdrawal Score (COWS) and Subjective Opiate Withdrawal Score (SOWS): participants with untreated OUD prior to study entry were more likely to experience an earlier relative peak in opioid withdrawal followed by a gradual decline, whereas participants on stable BUP treatment prior to study entry were more likely to experience a relatively later, though still mild, peak opioid withdrawal. The peak COWS was reached at a mean (standard deviation) of 1.9 (1.5) days for participants with untreated OUD and 5.0 (1.5) days for participants on stable BUP. Daily peak cravings were generally higher for participants with untreated OUD than participants on stable BUP. Conclusion Awareness of population-specific variations in the patient experience of opioid withdrawal may help clinicians anticipate the expected course of withdrawal.

Research paper thumbnail of Buprenorphine physician–pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network

Addiction, 2021

ABSTRACTBackground and AimsPhysician and pharmacist collaboration may help address the shortage o... more ABSTRACTBackground and AimsPhysician and pharmacist collaboration may help address the shortage of buprenorphine‐waivered physicians and improve care for patients with opioid use disorder (OUD). This study investigated the feasibility and acceptability of a new collaborative care model involving buprenorphine‐waivered physicians and community pharmacists.DesignNonrandomized, single‐arm, open‐label feasibility trial.SettingThree office‐based buprenorphine treatment (OBBT) clinics and three community pharmacies in the United States.ParticipantsSix physicians, six pharmacists, and 71 patients aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‐5) OUD on buprenorphine maintenance.InterventionAfter screening, eligible patients’ buprenorphine care was transferred from their OBBT physician to a community pharmacist for 6 months.MeasurementsPrimary outcomes included recruitment, treatment retention and adherence, and opioid use. Secondary outcomes w...

Research paper thumbnail of Psychological status, life and social conditions: A study in a population of institutionalized elderly people

International Journal of Geriatric Psychiatry, 1993

The relationship between social and life conditions on the one hand and the presence of depressio... more The relationship between social and life conditions on the one hand and the presence of depression on the other was analysed in a population of institutionalized elderly subjects. The influence of health status on psychological condition and the presence of endocrinological changes in hormones associated with chronic stress were investigated in depressed elderly people. One hundred and thirty‐seven elderly people (mean age 82.4 ± 7.7) were studied and 60 of them underwent a thorough psychiatric examination. The overall prevalence of depression‐not previously diagnosed in all but one patient—was 76.6%; 23.3% were severely depressed. Neither gender nor the presence of organic disease differentiated the depressed from the non‐depressed. The only two life and social variables associated with depression among the many items analysed were the length of institutionalization and the period of retirement. It was observed that a higher cortisol level in the severely depressed group showed a p...

Research paper thumbnail of Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended‐release naltrexone in a residential setting

The American Journal on Addictions, 2022

Background and ObjectivesTreatment for individuals receiving medication for opioid use disorder (... more Background and ObjectivesTreatment for individuals receiving medication for opioid use disorder (MOUD) should follow an informed patient‐centered approach. To better support patient autonomy in the decision‐making process, clinicians should be aware of patient preferences and be prepared to educate and assist patients in transitioning from one MOUD to another, when clinically indicated. This posthoc analysis describes the characteristics of clinical trial participants (NCT02696434) with a history of opioid use disorder (OUD) seeking to transition from buprenorphine (BUP) to extended‐release naltrexone (XR‐NTX).MethodsThe posthoc analysis included adults with OUD currently receiving BUP (≤8 mg/day) and seeking transition to XR‐NTX (N = 101) in a residential setting. Baseline participant characteristics and OUD treatment history were reviewed. All patients completed a screening questionnaire that asked about their reasons for seeking transition to XR‐NTX and for choosing BUP.ResultsTh...

Research paper thumbnail of Association of chronic non-cancer pain status and buprenorphine treatment retention among individuals with opioid use disorder: Results from electronic health record data

Drug and Alcohol Dependence Reports, 2022

Research paper thumbnail of The high prevalence of substance use disorders among recent MDMA users compared with other drug users: Implications for intervention

Addictive Behaviors, Aug 1, 2009

Aim-In light of the resurgence in MDMA use and its association with polysubstance use, we investi... more Aim-In light of the resurgence in MDMA use and its association with polysubstance use, we investigated the 12-month prevalence of substance use disorders (SUDs) among adult MDMA users to determine whether they are at risk of other drug-related problems that would call for targeted interventions. Methods-Data were drawn from the 2006 National Survey on Drug Use and Health. Past-year adult drug users were grouped into three mutually exclusive categories: 1) recent MDMA users, who had used the drug within the past year; 2) former MDMA users, who had a history of using this drug but had not done so within the past year; and 3) other drug users, who had never used MDMA. Logistic regression procedures were used to estimate the association between respondents' SUDs and MDMA use while adjusting for their socioeconomic status, mental health, age of first use, and history of polydrug use. Results-Approximately 14% of adults reported drug use in the past year, and 24% of those pastyear drug users reported a history of MDMA use. Recent MDMA users exhibited the highest prevalence of disorders related to alcohol (41%), marijuana (30%), cocaine (10%), pain reliever/ opioid (8%), and tranquilizer (3%) use. Adjusted logistic regression analyses revealed that, relative to other drug users, those who had recently used MDMA were twice as likely to meet criteria for marijuana and pain reliever/opioid use disorders. They were also about twice as likely as former MDMA users to meet criteria for marijuana, cocaine, and tranquilizer use disorders. Conclusions-Seven out of ten recent MDMA users report experiencing an SUD in the past year. Adults who have recently used MDMA should be screened for possible SUDs to ensure early detection and treatment.

Research paper thumbnail of Adjuvant Trazodone in the Treatment of Alcoholism: An Open Study

Alcohol and Alcoholism, Jul 1, 1998

Serotonergic drugs have been proven to be helpful to alcoholics in maintaining abstinence. In thi... more Serotonergic drugs have been proven to be helpful to alcoholics in maintaining abstinence. In this open study, we report that the atypical antidepressant trazodone at low doses was able to significandy decrease craving for alcohol, depressive, and anxious symptoms in a number (25) of detoxified alcohol-dependent subjects after 3 months of treatment. Trazodone may, therefore, be an adjuvant in the therapy of alcoholism.

Research paper thumbnail of Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness

Nicotine & Tobacco Research, Oct 31, 2019

Introduction: High rates of tobacco use among people with serious mental illness (SMI), along wit... more Introduction: High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population. Methods: In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16. Results: Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = .010). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions. Conclusions: This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI. Implications: This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.

Research paper thumbnail of A Randomized, Double-blind, Placebo-controlled Trial of Augmentation With an Extended Release Formulation of Methylphenidate in Outpatients With Treatment-Resistant Depression

Journal of Clinical Psychopharmacology, Dec 1, 2006

We examined the efficacy and tolerability of augmentation with an extended release formulation of... more We examined the efficacy and tolerability of augmentation with an extended release formulation of methylphenidate (OROS MPH, Concerta) in patients with major depression who were nonresponders or partial responders to antidepressants. Sixty subjects with treatment-resistant depression (TRD) participated in a 4-week, randomized, double-blind, placebo-controlled study of augmentation with methylphenidate (18-54 mg/d). The preexisting antidepressant dose was unchanged. The primary efficacy measure was change in the 21-item Hamilton Depression Rating Scale from randomization to end of treatment. Data were analyzed with intent-to-treat with last observation carried forward approach. There were no statistically significant differences between the methylphenidate (n = 30) and placebo (n = 30) groups in reduction in 21-item Hamilton Depression Rating Scale scores (drug, -6.9; placebo, -4.7) from baseline to end of treatment (F1,47 = 1.24, P = 0.22), although responders were numerically higher in the extended-release methylphenidate group (40.0%) than in the placebo group (23.3%). On the secondary efficacy measures of changes in Clinical Global Impression-Improvement and Severity scores and Beck Depression Inventory-Second Edition, the drug failed to separate from placebo, although the proportion of responders in the drug group were numerically higher than placebo. There were no significant differences in weight, heart rate, and blood pressure changes between the 2 groups. The common adverse events were loss of appetite, nausea, headache, and anxiety. The mean dose of drug was 34.2 mg/d. The study did not demonstrate a statistically significant benefit for augmentation with methylphenidate in TRD. Combination of methylphenidate with antidepressants was well tolerated. Adequately powered, randomized, controlled trials are necessary to fully evaluate the efficacy of extended-release methylphenidate in TRD.

Research paper thumbnail of Erratum to: Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Dependence and Serious Mental Illness

Nicotine & Tobacco Research, Aug 6, 2020

Research paper thumbnail of Emergency therapeutical approach simulating ultrarapid opioid detoxification in methadone withdrawal precipitated by erroneous administration of naltrexone

European Journal of Emergency Medicine, Jun 1, 1999

Research paper thumbnail of Patient perspectives on community pharmacy administered and dispensing of methadone treatment for opioid use disorder: a qualitative study in the U.S

Addiction Science & Clinical Practice, Aug 2, 2023

Background Pharmacy administration and dispensing of methadone treatment for opioid use disorder ... more Background Pharmacy administration and dispensing of methadone treatment for opioid use disorder (PADMOUD) may address inadequate capability of opioid treatment programs (OTPs) in the US by expanding access to methadone at community pharmacies nationally. PADMOUD is vastly underutilized in the US. There is no published US study on OUD patients' perspectives on PADMOUD. Data are timely and needed to inform the implementation of PAD-MOUD in the US to address its serious opioid overdose crisis. Methods Patient participants of the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were interviewed to explore implementation-related factors for PADMOUD. All 20 participants of the parent study were invited to participate in this interview study. Each interview was recorded and transcribed verbatim. Thematic analysis was conducted to identify emergent themes. Results Seventeen participants completed the interview. Patients' perspectives on PADMOUD were grouped into five areas. Participants reported feasibility of taking the tablet formulation of methadone at the pharmacy and identified benefits from PADMOUD (e.g., better access, efficiency, convenience) compared with usual care at the OTP. Participants perceived support for PADMOUD from their family/friends, OTP staff, and pharmacy staff. PADMOUD was perceived to be a great option for stable patients with take-home doses and those with transportation barriers. The distance (convenience), office hours, and the cost were considered factors most influencing their decision to receive methadone from a pharmacy. Nonjudgmental communication, pharmacists' training on methadone treatment, selection of patients (stable status), workflow of PADMOUD, and protection of privacy were considered key factors for improving operations of PADMOUD. Conclusion This study presents the first findings on patient perspectives on PADMOUD. Participants considered pharmacies more accessible than OTPs, which could encourage more people to receive methadone treatment earlier and help transition stable patients from an OTP into a local pharmacy. The findings have timely implications for informing implementation strategies of PADMOUD that consider patients' views and needs.

Research paper thumbnail of The opioid overdose epidemic: opportunities for pharmacists

Substance Abuse and Rehabilitation, Jul 1, 2017

Research paper thumbnail of Pregnant Mothers With Substance Use Problems and Their Treatment in North Carolina

North Carolina medical journal, Jan 10, 2023

Research paper thumbnail of Transition of Patients with Opioid Use Disorder from Buprenorphine to Extended‐Release Naltrexone: A Randomized Clinical Trial Assessing Two Transition Regimens

American Journal on Addictions, Apr 4, 2020

Background and Objective: When patients seek to discontinue buprenorphine (BUP) treatment, monthl... more Background and Objective: When patients seek to discontinue buprenorphine (BUP) treatment, monthly injectable extendedrelease naltrexone (XR-NTX) may help them avoid relapse. The efficacy of low ascending doses of oral NTX vs placebo for patients transitioning from BUP to XR-NTX is evaluated in this study. Methods: In a phase 3, hybrid residential/outpatient study, clinically stable participants with opioid use disorder (N = 101), receiving BUP for more than or equal to 3 months and seeking antagonist treatment, were randomized (1:1) to 7 residential days of descending doses of BUP and low ascending doses of oral NTX (NTX/BUP, n = 50) or placebo (PBO-N/BUP, n = 51). Both groups received standing ancillary medications and psychoeducational counseling. Following negative naloxone challenge, participants received XR-NTX (day 8). The primary endpoint was the proportion of participants who received and tolerated XR-NTX. Results: There was no statistical difference between groups for participants receiving a first dose of XR-NTX: 68.6% (NTX/BUP) vs 76.0% (PBO-N/BUP; P = .407). The mean number of days with peak Clinical Opiate Withdrawal Scale (COWS) score less than or equal to 12 during the treatment period (days 1-7) was similar for NTX/BUP and PBO-N/BUP groups (5.8 vs 6.3; P = .511). Opioid withdrawal symptoms during XR-NTX induction and post-XR-NTX observation period (days 8-11) were mild and similar between groups (mean peak COWS score: NTX/BUP, 5.1 vs PBO-N/BUP, 5.4; P = .464). Adverse events were mostly mild/moderate. Conclusions and Scientific Significance: Low ascending doses of oral NTX did not increase induction rates onto XR-NTX compared with placebo. The overall rate of successful induction across treatment groups supports a brief BUP taper with standing ancillary medications as a well-tolerated approach for patients seeking transition from BUP to XR-NTX.

Research paper thumbnail of Review of Popularity and Quality Standards of Opioid-Related Smartphone Apps

Current Addiction Reports, Nov 10, 2020

Purpose of review:Opioid misuse, addiction, and related harm is a global crisis that affects publ... more Purpose of review:Opioid misuse, addiction, and related harm is a global crisis that affects public health and social and economic welfare. Many of the strategies being used to combat the opioid crisis could benefit from improved access and dissemination, such as that afforded by smartphone apps. The goal of this study was to characterize the purpose, audience, quality and popularity of opioid-related smartphone apps. Using web scraping, available information from 619 opioid-related apps (e.g., popularity metrics) was downloaded from Google Play, and 59 apps met criteria for review. The apps were additionally coded for quality by two raters using an 8-item screener for the American Psychiatric Association App Evaluation Model.Findings:Sixty one percent of apps targeted patients, 29% providers, 8% the general community, and 2% healthcare trainees. Regarding app purpose, 49% addressed treatment, 27% prevention, and 24% overdose. Only one app met all criteria on the screener for quality, and there was no association between a total score calculated for the screener and measures of app popularity (e.g., star ratings; R2=0.10, p=0.19).Summary:Opioid-related apps available for consumers addressed key stakeholders (patients, providers, community) and were consistent with strategies to address the opioid crisis (prevention, treatment, overdose). However, there was little evidence that available opioid-related apps meet basic quality standards, and no relationship was found between app quality and popularity. This review was conducted at the level of consumer decision-making (i.e., the app store), where only a handful of opioid-related apps met quality standards enough to warrant a more detailed evaluation of the app before recommendation for use. Because smartphone apps could be a critical tool to increase access to and utilization of opioid prevention, treatment, and recovery services, further development and testing is sorely needed.

Research paper thumbnail of New Pharmacological Targets for the Treatment of Excessive Alcohol use

Current drug research reviews, Nov 1, 2022

Research paper thumbnail of Meet Our Co-Editor-in-Chief

Current drug research reviews, Feb 26, 2019

Research paper thumbnail of Feasibility of very low dose naltrexone and buprenorphine transition from opioid use to extended-release naltrexone

Drug and Alcohol Dependence, 2015

Research paper thumbnail of Heroin Use in Older Adults: A Treatment Challenge

American Journal of Geriatric Psychiatry, May 1, 2021

Research paper thumbnail of Patterns of withdrawal in patients with opioid use disorder (OUD) transitioning from untreated OUD or buprenorphine treatment to extended-release naltrexone

The American Journal of Drug and Alcohol Abuse, 2021

ABSTRACT Background Pharmacologic treatment is recommended for many individuals with opioid use d... more ABSTRACT Background Pharmacologic treatment is recommended for many individuals with opioid use disorder (OUD). For patients who select opioid antagonist treatment, effective management of opioid withdrawal symptoms during transition to antagonist treatment requires consideration of the patient experience. Objectives To compare patterns of opioid withdrawal between those withdrawing from untreated opioid use and those withdrawing from buprenorphine. Methods We performed a post hoc, cross-study comparison of the temporal pattern of opioid withdrawal during 1-week induction onto extended-release naltrexone by similar protocols enrolling two participant populations: participants with OUD entering a study with untreated opioid use (N = 378, NCT02537574) or on stable buprenorphine (BUP) treatment (N = 101, NCT02696434). Results The temporal pattern of withdrawal from induction day 1 through day 7 differed between the two participant populations for Clinical Opiate Withdrawal Score (COWS) and Subjective Opiate Withdrawal Score (SOWS): participants with untreated OUD prior to study entry were more likely to experience an earlier relative peak in opioid withdrawal followed by a gradual decline, whereas participants on stable BUP treatment prior to study entry were more likely to experience a relatively later, though still mild, peak opioid withdrawal. The peak COWS was reached at a mean (standard deviation) of 1.9 (1.5) days for participants with untreated OUD and 5.0 (1.5) days for participants on stable BUP. Daily peak cravings were generally higher for participants with untreated OUD than participants on stable BUP. Conclusion Awareness of population-specific variations in the patient experience of opioid withdrawal may help clinicians anticipate the expected course of withdrawal.

Research paper thumbnail of Buprenorphine physician–pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network

Addiction, 2021

ABSTRACTBackground and AimsPhysician and pharmacist collaboration may help address the shortage o... more ABSTRACTBackground and AimsPhysician and pharmacist collaboration may help address the shortage of buprenorphine‐waivered physicians and improve care for patients with opioid use disorder (OUD). This study investigated the feasibility and acceptability of a new collaborative care model involving buprenorphine‐waivered physicians and community pharmacists.DesignNonrandomized, single‐arm, open‐label feasibility trial.SettingThree office‐based buprenorphine treatment (OBBT) clinics and three community pharmacies in the United States.ParticipantsSix physicians, six pharmacists, and 71 patients aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‐5) OUD on buprenorphine maintenance.InterventionAfter screening, eligible patients’ buprenorphine care was transferred from their OBBT physician to a community pharmacist for 6 months.MeasurementsPrimary outcomes included recruitment, treatment retention and adherence, and opioid use. Secondary outcomes w...

Research paper thumbnail of Psychological status, life and social conditions: A study in a population of institutionalized elderly people

International Journal of Geriatric Psychiatry, 1993

The relationship between social and life conditions on the one hand and the presence of depressio... more The relationship between social and life conditions on the one hand and the presence of depression on the other was analysed in a population of institutionalized elderly subjects. The influence of health status on psychological condition and the presence of endocrinological changes in hormones associated with chronic stress were investigated in depressed elderly people. One hundred and thirty‐seven elderly people (mean age 82.4 ± 7.7) were studied and 60 of them underwent a thorough psychiatric examination. The overall prevalence of depression‐not previously diagnosed in all but one patient—was 76.6%; 23.3% were severely depressed. Neither gender nor the presence of organic disease differentiated the depressed from the non‐depressed. The only two life and social variables associated with depression among the many items analysed were the length of institutionalization and the period of retirement. It was observed that a higher cortisol level in the severely depressed group showed a p...

Research paper thumbnail of Characteristics and treatment preferences of individuals with opioid use disorder seeking to transition from buprenorphine to extended‐release naltrexone in a residential setting

The American Journal on Addictions, 2022

Background and ObjectivesTreatment for individuals receiving medication for opioid use disorder (... more Background and ObjectivesTreatment for individuals receiving medication for opioid use disorder (MOUD) should follow an informed patient‐centered approach. To better support patient autonomy in the decision‐making process, clinicians should be aware of patient preferences and be prepared to educate and assist patients in transitioning from one MOUD to another, when clinically indicated. This posthoc analysis describes the characteristics of clinical trial participants (NCT02696434) with a history of opioid use disorder (OUD) seeking to transition from buprenorphine (BUP) to extended‐release naltrexone (XR‐NTX).MethodsThe posthoc analysis included adults with OUD currently receiving BUP (≤8 mg/day) and seeking transition to XR‐NTX (N = 101) in a residential setting. Baseline participant characteristics and OUD treatment history were reviewed. All patients completed a screening questionnaire that asked about their reasons for seeking transition to XR‐NTX and for choosing BUP.ResultsTh...

Research paper thumbnail of Association of chronic non-cancer pain status and buprenorphine treatment retention among individuals with opioid use disorder: Results from electronic health record data

Drug and Alcohol Dependence Reports, 2022