Gabapentin Treatment of Cannabis Dependence

Study Overview
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Brief Summary
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This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

Detailed Description
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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. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.

Official Title
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Gabapentin Treatment of Cannabis Dependence

Conditions
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Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits

Intervention / Treatment
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* Drug: gabapentin 1200mg/day
* Drug: Placebo
* Behavioral: Manual-guided behavioral counseling


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Abstinent from cannabis more than 2 days at the time of randomization 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, 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, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin 1200mg/day<br>1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. | Drug: gabapentin 1200mg/day<br>* gabapentin 1200mg/day for 12 weeks<br>* Other names: Neurontin;Behavioral: Manual-guided behavioral counseling<br>* Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.<br>* Other names: Manual-guided therapy;|
| Placebo Comparator: Placebo<br>1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. | Drug: Placebo<br>* 1200mg/day of placebo for 12 weeks<br>Behavioral: Manual-guided behavioral counseling<br>* Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.<br>* Other names: Manual-guided therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis Treatment, Cannabis Use, Cannabis Dependence, Executive Functioning, Cognitive Deficits