Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms

Center for Addiction and Mental Health (CAMH)

Status and phase: Terminated; Phase 4

Conditions: Substance-Related Disorders

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT02423018

079-2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to the Medical Withdrawal Unit at the Centre for Addiction and Mental Health for medically assisted withdrawal from benzodiazepines, zopiclone and/or zolpidem
• Willing and capable to give written informed consent

Exclusion criteria

• Patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.
• Pregnant or nursing women
• Renal impairment (creatinine clearance less than 60ml/min)
• History of angioedema, or taking drugs associated with angioedema (e.g., ACE-inhibitors).
• Currently taking pregabalin or gabapentin
• Currently taking thiazolidinedione antidiabetic agents (e.g., rosiglitazone, pioglitazone)
• Previous history of pregabalin or gabapentin abuse

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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1 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Description:

Pregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days

Treatment:

Drug: Pregabalin

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo for 10 days

Treatment:

Drug: Pregabalin

Drug: Placebo