Substance-Related Disorders Clinical Trial
Official title:
Evaluation of Pregabalin's Abuse Liability and Its Effects on Benzodiazepine Withdrawal Symptoms in Inpatients Undergoing Medically Assisted Benzodiazepine Withdrawal
The purpose of this study is to determine if a single dose of pregabalin 300mg in patients receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful differences in measures of "drug liking" and "drug high" as compared to placebo.
Pregabalin is currently being explored as a pharmacotherapy for substance use disorders.
Open-labeled, uncontrolled studies indicate modest efficacy of pregabalin in benzodiazepine
withdrawal symptom management and as a long-term benzodiazepine dependence treatment.
Concurrently, there is increasing information from case reports and adverse drug event
registries regarding pregabalin abuse in patients with substance use disorders.
Given that the abuse liability of pregabalin has not been clearly established, nor its
effects on benzodiazepine withdrawal symptoms in inpatients, this study is a randomized,
double-blind, placebo-controlled, cross-over, abuse liability study of a single dose of
pregabalin 300mg, nested within a randomized,double-blind placebo-controlled, feasibility
study evaluating pregabalin's effects on withdrawal symptoms in inpatients undergoing
medically-assisted withdrawal from benzodiazepine, zopiclone or zolpidem.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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