Gabapentin Treatment of Cannabis Dependence

Cannabis Dependence Clinical Trial

Official title:

Gabapentin Treatment of Cannabis Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974376
• Other study ID #: DA026758
• Secondary ID: 5R01DA026758-05
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2009
• Last updated: December 7, 2016
• Start date: August 2009
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Dependence
• Cannabis Withdrawal
• Cognition Disorders
• Cognitive Deficits
• Marijuana Abuse

Intervention

Drug:
• gabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
• Placebo
1200mg/day of placebo for 12 weeks

Behavioral:
• Manual-guided behavioral counseling
Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.

Locations

Country	Name	City	State
United States	The Scripps Research Institute	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis Use	Urinary THC	Measured 1x per week for 12 weeks	No

External Links

•   Study Website
•   Study-related information