Gabapentin Treatment of Cannabis Dependence
This study is currently recruiting participants.
Verified July 2012 by The Scripps Research Institute
Sponsor:
The Scripps Research Institute
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00974376
First received: September 1, 2009
Last updated: July 19, 2012
Last verified: July 2012
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Purpose
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Cannabis Dependence Cannabis Withdrawal Cognitive Deficits |
Drug: gabapentin 1200mg/day Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Gabapentin Treatment of Cannabis Dependence |
Resource links provided by NLM:
Further study details as provided by The Scripps Research Institute:
Primary Outcome Measures:
- Cannabis Use [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Cannabis Withdrawal [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Executive Functioning [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sleep [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Mood [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Craving [ Time Frame: Weekly ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gabapentin 1200mg/day
1200mg/day of gabapentin
|
Drug: gabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
Other Name: Neurontin
|
|
Placebo Comparator: Placebo
1200mt/day placebo
|
Drug: Placebo
1200mg/day of placebo
|
Detailed Description:
This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Baseline assessments using measurement instruments are conducted on cannabis use, neuropsychological functioning, withdrawal, craving, pain, mood and sleep. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months and include assessments in withdrawal, craving, pain, mood and sleep. A final, follow-up visit occurs at the end of the 3 months.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males or females from 18-65 years of age
- Meets DSM IV criteria for current cannabis dependence
- Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
- Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
- At least a 2-year history of regular MJ use
- Experienced ≥ 2 withdrawal symptoms during prior cessation periods
- Willing to attend 12 weekly study visits and 1 follow-up visit
Exclusion Criteria:
- Abstinent from cannabis more than 2 days at the time of randomization
- Subjects for whom MJ is medically prescribed
- Active suicidal ideation
- Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
- Significant medical disorders that will increase potential risk or interfere with study participation, e.g., plasma creatinine >1.4mg/dL
- History of neurological disorder, e.g., seizures, meningitis, migraine, HIV, head trauma with loss of consciousness > 2 minutes, or learning disability
- Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
- Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence, including depressive and anxiety disorders, and is in need of, or currently undergoing, pharmacotherapy
- Inability to understand and/or comply with the provisions of the protocol and consent form
- Treatment with an investigational drug during the previous month
- Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
- Ongoing treatment with medications that may affect study outcomes, e.g., acamprosate, antidepressants, benzodiazepines, or other psychoactive medications
- Subjects for whom treatment of cannabis use is being mandated by a legal authority
- Subjects who plan to move out of the geographic area served by the Clinic prior to study completion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974376
Contacts
| Contact: Rebecca Crean, Ph.D. | (858) 784=7334 | rcrean@scripps.edu |
Locations
| United States, California | |
| The Scripps Research Institute | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Rebecca Crean, Ph.D. 858-784-7334 rcrean@scripps.edu | |
| Principal Investigator: Barbara J Mason, Ph.D. | |
| Sub-Investigator: Rebecca Crean, Ph.D. | |
Sponsors and Collaborators
The Scripps Research Institute
Investigators
| Principal Investigator: | Barbara J Mason, Ph.D. | The Scripps Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara J. Mason, PI, The Scripps Research Institute |
| ClinicalTrials.gov Identifier: | NCT00974376 History of Changes |
| Other Study ID Numbers: | DA026758, DA026758 |
| Study First Received: | September 1, 2009 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Scripps Research Institute:
|
Cannabis Treatment Cannabis Use Cannabis Dependence Executive Functioning Cognitive Deficits |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents |
Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 23, 2013