Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms (NCT02423018) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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