Gabapentin Treatment of Cannabis Dependence

NCT ID: NCT00395044

Last Updated: 2017-02-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-07-31

Brief Summary

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This is a 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, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. Counseling and research assessments occur weekly throughout the 12-week treatment phase.

Conditions

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Cannabis Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Gabapentin

1200 mg/daily of Gabapentin

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Placebo

1200mg/d of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Placebo

Placebo

Intervention Type DRUG

Gabapentin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females age 18-65 with cannabis dependence
* Meets DSM-IV-TR criteria for Cannabis Dependence
* Smoked marijuana at least once a week in the 90 days prior to study participation
* Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria

* Currently meets DSM-IV-TR criteria for dependence on illicit substances other than cannabis
* Significant medical disorders that will increase potential risk or interfere with study participation
* Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
* Treatment with an investigational drug in the last month
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

The Scripps Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Barbara J. Mason

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara J. Mason, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Scripps Research Institute- Pearson Center for Alcoholism and Addiction Research

Locations

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The Scripps Research Institute

La Jolla, California, United States

Site Status

Countries

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United States

References

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Mason BJ, Crean R, Goodell V, Light JM, Quello S, Shadan F, Buffkins K, Kyle M, Adusumalli M, Begovic A, Rao S. A proof-of-concept randomized controlled study of gabapentin: effects on cannabis use, withdrawal and executive function deficits in cannabis-dependent adults. Neuropsychopharmacology. 2012 Jun;37(7):1689-98. doi: 10.1038/npp.2012.14. Epub 2012 Feb 29.

Reference Type RESULT
PMID: 22373942 (View on PubMed)

Other Identifiers

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5R21DA020766-01

Identifier Type: NIH

Identifier Source: secondary_id

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DA020766-01

Identifier Type: -

Identifier Source: org_study_id

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