Timing of nicotine lozenge administration to minimize trigger induced craving and withdrawal symptoms (original) (raw)
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The impact of nicotine lozenges and stimulus expectancies on cigarette craving
Journal of Psychopharmacology, 2014
Reduced craving associated with nicotine replacement therapy use is frequently attributed to the effects of nicotine pharmacology, however nonpharmacological factors may also play a role. This study examined the impact of nicotine pharmacology and non-pharmacological components of an acute nicotine lozenge (4 mg) on cigarette craving, mood and heart rate in 70 daily smokers (36 male). Smoking-related stimuli were used to assess cue-induced craving. Participants were randomly assigned to one of four conditions in a balanced placebo design where half the participants were provided deceptive information regarding the nicotine content of a lozenge. Subjective ratings of craving and mood were collected and heart rate was assessed before and after neutral and smoking cues. Nicotine expectancy reduced withdrawal-related craving (p=0.006) regardless of actual nicotine administration while combined nicotine expectancy and administration reduced intentions to smoke (p=0.046) relative to each of the other conditions. Exposure to smoking-related stimuli increased cigarette craving (p≤0.001) and negative affect (p≤0.001) regardless of expectancy or pharmacology. Following the smoking cue, women reported a greater increase in withdrawal-related craving than men (p=0.027). Findings suggest that both pharmacological and non-pharmacological components of nicotine lozenge administration contribute to its acute effects on craving, yet neither appears effective in preventing craving triggered by exposure to environmental smoking stimuli.
Nicotine Lozenges in the Relief of Behaviorally Provoked Craving
American Journal of Health Behavior, 2018
Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation. Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored. Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: −41.8; 95% confidence interval [CI]: −45.8, −37.7) versus placebo (−25.9; 95% CI: −30.0, −21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges. Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.
Comparison of craving and withdrawal among four combination nicotine treatments
Human Psychopharmacology: Clinical and Experimental, 2008
Objective To assess the appearance of craving and withdrawal among four combination nicotine replacement treatments (NRTs). Methods In a crossover trial of NRT preferences, 27 smokers tested 4 combinations of nicotine treatments: 2 mg/4 mg gums þ 15 mg patch, 2 mg/4 mg lozenges þ 15 mg patch, inhalers þ 15 mg patch, and 10 þ 15 mg double patch (25 mg). Overnight abstinence was required prior to ½ day testing of each combination. Combination NRTs were used for 6 h/day. Subjects resumed smoking each afternoon. For this report, we used the Smoker Anchored Withdrawal Grid to look at craving and withdrawal scores over 5 days of testing (smoking baseline þ four treatment days). Results ''Urge to smoke'' and ''total withdrawal'' showed a rise from baseline to NRT use for the double patch but not for the three acute þ patch conditions. Lozenge/patch scores did not rise from baseline for ''craving'' and ''miss a cigarette'' but did for gum/patch, inhaler/patch, and double patch. The best relief occurred for NRTs of choice. Conclusion This was a small but suggestive finding regarding the potential of patch plus adjunct ad lib NRT. With little data on relief with NRT combinations, more systematic tests are needed.
Addiction, 2010
To determine effects on craving, user satisfaction, and consumption patterns of two new nicotine replacement therapies (NRT) used for eight hours after overnight tobacco abstinence. Design In a within-subject, cross-over trial participants were randomly assigned Zonnic® nicotine mouth spray (1 mg/spray), Zonnic® nicotine lozenge (2.5 mg), Nicorette® gum (4 mg) and placebo lozenge on each of four study days. Setting University research unit. Participants Forty-seven dependent adult smokers. Measurements Participants rated their urges to smoke, irritability, concentration and restlessness before and during the first hour of product use on a 100-point scale. A subsample of 11 participants provided blood samples for nicotine analysis. Findings All active products reduced craving significantly more than placebo (mean reductions of 28.6, 25.8, 24.7 and 8.9 points for mouth spray, gum, lozenge and placebo). Mouth spray relieved craving faster than placebo and gum with significant reductions within five minutes of use (mean differences of -14.5 (95% CI: -23.0 to -6.0) and -10.6 (95% CI: -19.1 to -2.1) with placebo and gum respectively. Mouth spray produced a faster time to maximum plasma nicotine concentration (14.5 minutes, 95% CI: 8.0 to 21.0) compared to the lozenge (30.3 minutes, 95% CI: 21.1 to 39.5) and gum (45.8 minutes, 95% CI: 36.2 to 55.4). Maximum concentrations of blood nicotine were higher with mouth spray (10.0 ng/ml) and lozenge (10.8 ng/ ml) compared to gum (7.8 ng/ml). Both lozenge and mouth spray were well tolerated. Conclusions The mouth spray and lozenge are at least as effective as 4 mg nicotine gum in relieving craving suggesting that they are likely to be effective in aiding smoking cessation. The mouth spray may be particularly useful for acute craving relief.
Effects of cigarette nicotine content and smoking pace on subsequent craving and smoking
Psychopharmacology, 2003
The relative contribution of sensory and pharmacological variables in regulating craving and smoking remains unclear. Rapid smoking procedures and denicotinized cigarettes can be used to further disentangle these factors, and to explore the relationship between craving and smoking. The present study examined the role of nicotine and sensory cues in mediating craving and smoking, and the relationship between craving and smoking. Participants ( n=15) engaged in one session each of rapid smoking (up to nine cigarettes with puffs taken every 6 s) and normal paced smoking with nicotinized and denicotinized cigarettes (total of four sessions). During the next 3 h, craving and withdrawal assessments and smoking opportunities were scheduled every 15 min. Plasma nicotine levels were measured at baseline, immediately and 15 min after the smoking interventions, and subsequently at the time when the participant first chose to smoke. Craving ratings were equally suppressed immediately after all ...
Addiction, 2005
Aims Most relapse episodes occur when smokers are confronted with craving provoked by situational cues. Current nicotine gum can help relieve cueprovoked cravings, but faster effects may result in more rapid relief. We tested a prototype formulation of a new rapid-release nicotine gum (RRNG) that provides more rapid release and absorption of nicotine, for its ability to provide faster and better craving relief compared to current nicotine polacrilex gum (NPG). Design Random assignment to RRNG or NPG, used during a smoking cue provocation procedure. Participants and setting A total of 319 smokers were exposed to a smoking cue in the laboratory by being asked to light but not smoke a cigarette of their preferred brand. Subjects then chewed a piece of 2 mg RRNG ( n = 159) or 2 mg NPG ( n = 160) according to randomized assignment. Measurements Craving assessments were completed at regular intervals before and after cue exposure (baseline, pre-cue, and 3, 6, 9, 12, 15, 18, 21, 25, 30 and 35 minutes after the cue). Findings Smokers chewing RRNG showed significantly lower craving than NPG subjects starting with the first assessment at 3 minutes ( P < 0.025). Repeated-measures ANOVA revealed a significant treatment ¥ time interaction ( P < 0.05)-craving scores dropped more rapidly in RRNG subjects compared to NPG subjects. Survival analyses also indicated superiority of RRNG in achieving more rapid self-reported meaningful relief ( P < 0.05) and complete relief ( P < 0.05) of craving. Conclusions Rapid-release nicotine gum reduced cue-provoked craving more rapidly compared to NPG, and thus merits further study in cessation efficacy trials.
Efficacy of a Nicotine Lozenge for Smoking Cessation
Archives of Internal Medicine, 2002
Background: Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation.
Subjective effects of the nicotine lozenge: assessment of abuse liability
Psychopharmacology, 2003
Rationale A nicotine lozenge was developed as a novel smoking cessation aid. Abuse liability, which in this context refers to use by novices not addicted to tobacco, may be expected to be low for the lozenge due to the relatively slow route of nicotine absorption. However, its resemblance to commercially marketed lozenges and its palatability, intended to increase medication compliance, may increase its abuse liability, especially among younger individuals. Objectives The present study evaluated the abuse liability of the nicotine lozenge. Effects of the lozenge on cigarette craving were also measured. Methods Subjective and physiological effects of the nicotine lozenge were tested in healthy adult smokers (n=12, 22–55 years old); a group of younger subjects (n=12, 18–21 years) was also included to allow for assessment of abuse liability of the lozenge in young adults specifically. Amphetamine and a confectionery lozenge were included in the study conditions as positive controls for abuse liability and palatability, respectively, and nicotine gum was included to allow for comparison with a marketed oral nicotine replacement product with low abuse liability. Results The nicotine lozenge did not increase ratings of traditional abuse liability predictors (good effect, like effect, MBG scale of the ARCI), while amphetamine significantly increased ratings on these measures. The lozenge dose dependently decreased craving for cigarettes after 70 min of abstinence, but only in the older group. Palatability of the lozenge was rated lower than a confectionery lozenge, but not lower than nicotine mint gum. Conclusions Results suggest that the nicotine lozenge has low abuse liability, both in adults and young adults. The lozenge reduces craving to smoke, although craving reduction may not apply to young adults (18–21 years). Subjective effects of the lozenge are consistent with utility as a smoking cessation aid and are comparable to those of nicotine gum.