Gabapentin Treatment of Cannabis Dependence

The Scripps Research Institute

Status and phase: Completed; Phase 2

Conditions: Cannabis Withdrawal; Cannabis Dependence; Cognitive Deficits

Treatments: Drug: Placebo; Drug: gabapentin 1200mg/day; Behavioral: Manual-guided behavioral counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00974376

DA026758

5R01DA026758-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Gabapentin 1200mg/day

Experimental group

Description:

1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.

Treatment:

Behavioral: Manual-guided behavioral counseling

Drug: gabapentin 1200mg/day

Placebo

Placebo Comparator group

Description:

1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.

Treatment:

Behavioral: Manual-guided behavioral counseling

Drug: Placebo