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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
1
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.
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.
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
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
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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