An exploratory evaluation of Take Control: A novel computer-delivered behavioral platform for placebo-controlled pharmacotherapy trials for alcohol use disorder - PubMed (original) (raw)

Randomized Controlled Trial

An exploratory evaluation of Take Control: A novel computer-delivered behavioral platform for placebo-controlled pharmacotherapy trials for alcohol use disorder

Eric G Devine et al. Contemp Clin Trials. 2016 Sep.

Abstract

Placebo-controlled pharmacotherapy trials for alcohol use disorder (AUD) require an active behavioral platform to avoid putting participants at risk for untreated AUD and to better assess the effectiveness of the medication. Therapist-delivered platforms (TDP) can be costly and present a risk to study design because of the variability in therapist fidelity. Take Control is a novel computer-delivered behavioral platform developed for use in pharmacotherapy trials sponsored by the National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG). This behavioral platform was developed with the goal of reducing trial implementation costs and limiting potential bias introduced by therapists providing TDP. This exploratory study is the first to compare Take Control with TDP on measures related to placebo response rate, medication adherence, and participant retention. Data were drawn from the placebo arms of four multisite, double-blind, randomized controlled trials (RCT) for AUD conducted by NCIG from 2007 to 2015. Data were compared from subjects receiving TDP (n=156) in two RCTs and Take Control (n=155) in another two RCTs. Placebo response rate, as represented by weekly percentage of heavy drinking days, was similar between groups. Subjects who received Take Control had a higher rate of medication adherence than those who received TDP. Subject retention was not significantly different between groups. The findings suggest that Take Control is comparable to TDP on measures of retention, medication adherence, and placebo response. Additional research is needed to evaluate Take Control directly against TDPs in a randomized trial.

Keywords: Alcohol use disorder; Behavioral platform; Computer-based intervention; Randomized controlled trial; Take control.

Copyright © 2016 Elsevier Inc. All rights reserved.

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Figures

Figure 1

Figure 1

Placebo Response Rate (Percent Heavy Drinking Days outcome) - Take Control vs Therapist Delivered Platform

Figure 2

Figure 2

Medication Adherence Rate - Take Control vs vs Therapist-Delivered Platform

Figure 3

Figure 3

Prevalence of Complete Drinking Data - Take Control vsvs Therapist-Delivered Platform

Figure 4

Figure 4

Visit Participation Rate - Take Control vs Therapist-Delivered Platform

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