Substance-Related Disorders Clinical Trial
Official title:
Evaluation of Pregabalin's Abuse Liability and Its Effects on Benzodiazepine Withdrawal Symptoms in Inpatients Undergoing Medically Assisted Benzodiazepine Withdrawal
Verified date | March 2016 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | No | |
Other | Change in score on the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI) | Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm) | No | |
Other | Clinical Global Impression Scale - Severity | Day 0 | No | |
Other | Clinical Global Impression Scale - Improvement | Day 10 | No | |
Other | Benzodiazepine use post-discharge | Assess benzodiazepine use since discharge | 30 days post-discharge | No |
Other | Pregabalin use post-discharge | Assess pregabalin use since discharge | 30 days post-discharge | No |
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | Psychomotor Performance (Digit Symbol Substitution Test (DSST) | Digit Symbol Substitution Test (DSST) | On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose | No |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Tmax Estimated peak plasma pregabalin concentration | Estimated peak plasma pregabalin concentration | On Days 6 and 8 only: obtained 1 hour post-dose | No |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05054738 -
CRP and S&A for Inpatient Veterans
|
N/A | |
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Completed |
NCT02233738 -
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
|
N/A | |
Enrolling by invitation |
NCT06084221 -
Fatal Overdose Review Teams - Research to Enhance Surveillance Systems
|
N/A | |
Completed |
NCT02907944 -
Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation
|
N/A | |
Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
Completed |
NCT02570360 -
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
|
N/A | |
Completed |
NCT02125539 -
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
|
Phase 2 | |
Completed |
NCT02715557 -
Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
|
N/A | |
Completed |
NCT02388243 -
The Computer-based Drug and Alcohol Training Assessment in Kenya
|
N/A | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT02218970 -
The Effect of Muscular Strength Training in Patients With Drug Addiction
|
N/A | |
Completed |
NCT01633138 -
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
|
N/A | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Withdrawn |
NCT01224002 -
A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
|
N/A | |
Withdrawn |
NCT00891631 -
Primary Care iSBIRT to Reduce Serious Teen Health Risks
|
Phase 1/Phase 2 | |
Completed |
NCT01365247 -
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00970372 -
Dual-Diagnosis and Compulsory Treatment
|
N/A | |
Completed |
NCT00419029 -
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
|
N/A |