TerminatedPhase 4

Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms

Stopped: Low enrollment.

Canada1 participantsStarted 2015-04

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration

Timeframe: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

Trial details

NCT IDNCT02423018

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

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