title: An exploratory evaluation of Take Control: A novel computer-delivered behavioral platform for placebo-controlled pharmacotherapy trials for alcohol use disorder.
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.
authors: Department of Psychiatry, Boston University School of Medicine, Boston, MA, USA. Electronic address: eric.devine@bmc.org.
authors: Eric G
authors: EG
authors: Devine
authors: NIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
authors: Megan L
authors: ML
authors: Ryan
authors: NIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
authors: Daniel E
authors: DE
authors: Falk
authors: NIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
authors: Joanne B
authors: JB
authors: Fertig
authors: NIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
authors: Raye Z
authors: RZ
authors: Litten
mesh_terms: D000328:Adult; D019973:Alcohol-Related Disorders / Q000188:drug therapy / Q000628:therapy*; D065092:Antidiuretic Hormone Receptor Antagonists / Q000627:therapeutic use; D001521:Behavior Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D010889:Piracetam / Q000031:analogs & derivatives / Q000627:therapeutic use; D010919:Placebos; D000069348:Quetiapine Fumarate / Q000627:therapeutic use; D012107:Research Design; D012984:Software; D000068580:Varenicline / Q000627:therapeutic use; D016903:Drug Monitoring
chemical_list: D065092:Antidiuretic Hormone Receptor Antagonists; D010919:Placebos; D000069348:Quetiapine Fumarate; D000077287:Levetiracetam; D000068580:Varenicline; D010889:Piracetam
keywords: Alcohol use disorder; Behavioral platform; Computer-based intervention; Randomized controlled trial; Take control