Gabapentin Treatment of Cannabis Dependence - Full Text View

Sponsor:	The Scripps Research Institute
Information provided by:	The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00974376

Purpose

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

Condition	Intervention	Phase
Cannabis Dependence Cannabis Withdrawal Cognitive Deficits	Drug: gabapentin 1200mg/day Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Gabapentin Treatment of Cannabis Dependence

Resource links provided by NLM:

Drug Information available for: GW-1000 Gabapentin Gabapentin enacarbil Cannabis

U.S. FDA Resources

Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:

Cannabis Use [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Cannabis Withdrawal [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Executive Functioning [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sleep [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Mood [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Craving [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	August 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gabapentin 1200mg/day 1200mg/day of gabapentin	Drug: gabapentin 1200mg/day gabapentin 1200mg/day for 12 weeks Other Name: Neurontin
Placebo Comparator: Placebo 1200mt/day placebo	Drug: Placebo 1200mg/day of placebo

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Experienced ≥ 2 withdrawal symptoms during prior cessation periods
Willing to attend 12 weekly study visits and 1 follow-up visit

Exclusion Criteria:

Abstinent from cannabis more than 2 days at the time of randomization
Subjects for whom MJ is medically prescribed
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, e.g., plasma creatinine >1.4mg/dL
History of neurological disorder, e.g., seizures, meningitis, migraine, HIV, head trauma with loss of consciousness > 2 minutes, or learning disability
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, including depressive and anxiety disorders, and is in need of, or currently undergoing, pharmacotherapy
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, e.g., acamprosate, antidepressants, benzodiazepines, or other psychoactive medications
Subjects for whom treatment of cannabis use is being mandated by a legal authority
Subjects who plan to move out of the geographic area served by the Clinic prior to study completion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974376

Contacts

Contact: Rebecca Crean, Ph.D.

(858) 784=7334

rcrean@scripps.edu

Locations

United States, California
The Scripps Research Institute	Recruiting
La Jolla, California, United States, 92037
Contact: Rebecca Crean, Ph.D. 858-784-7334 rcrean@scripps.edu
Principal Investigator: Barbara J Mason, Ph.D.
Sub-Investigator: Rebecca Crean, Ph.D.

Sponsors and Collaborators

The Scripps Research Institute

Investigators

Principal Investigator:

Barbara J Mason, Ph.D.

The Scripps Research Institute

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Study Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Barbara J. Mason, Ph.D., The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00974376 History of Changes
Other Study ID Numbers:	DA026758, DA026758
Study First Received:	September 1, 2009
Last Updated:	June 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by The Scripps Research Institute:

Cannabis Treatment
Cannabis Use
Cannabis Dependence
Executive Functioning
Cognitive Deficits

Additional relevant MeSH terms:

Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents

Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012