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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


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
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