A Phase 4 interventional study of Pregabalin and Placebo in Substance-Related Disorders, sponsored by Centre for Addiction and Mental Health. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by Centre for Addiction and Mental Health · Phase 4, Interventional, and Basic science
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 1 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days
Drug: Pregabalin · Drug: Placebo
Placebo for 10 days
Drug: Pregabalin · Drug: Placebo
In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.
Also known as: Lyrica
In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.
Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Profile of Mood States (POMS)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Psychomotor Performance (Digit Symbol Substitution Test (DSST)
Digit Symbol Substitution Test (DSST)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Take Drug Again"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Any Drug Effects"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Good Effects"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Bad Effects"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Feel Sick"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Nausea"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Sleepy"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Dizzy"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Sedation (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Euphoria (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Dysphoric Changes (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Psychotomimetic Changes (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Somatic Disturbances (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Sensory Disturbances (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Tmax Estimated peak plasma pregabalin concentration
Estimated peak plasma pregabalin concentration
Time frame: On Days 6 and 8 only: obtained 1 hour post-dose
Change from baseline on Visual Analogue Scale for "Drug High" over 5 hours
Additional Primary Outcome
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Change in score on the Benzodiazepine Withdrawal Symptom Questionnaire
Time frame: Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm)
Change in score on the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm)
Clinical Global Impression Scale - Severity
Time frame: Day 0
Clinical Global Impression Scale - Improvement
Time frame: Day 10
Benzodiazepine use post-discharge
Assess benzodiazepine use since discharge
Time frame: 30 days post-discharge
Pregabalin use post-discharge
Assess pregabalin use since discharge
Time frame: 30 days post-discharge
Plan to share: Undecided
This study is terminated, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health