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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Active Comparator | Pregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days |
|
| Placebo | Placebo Comparator | Placebo for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration | On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States (POMS) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on the Benzodiazepine Withdrawal Symptom Questionnaire | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Sproule, PharmD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5S 3M2 | Canada |
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| Label | URL |
|---|---|
| The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world. | View source |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Placebo | Drug | 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. |
|
| 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" | 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" | 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" | 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" | 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" | 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" | 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" | 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" | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose |
| Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm) |
| Clinical Global Impression Scale - Severity | Day 0 |
| Clinical Global Impression Scale - Improvement | Day 10 |
| Benzodiazepine use post-discharge | Assess benzodiazepine use since discharge | 30 days post-discharge |
| Pregabalin use post-discharge | Assess pregabalin use since discharge | 30 days post-discharge |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |