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Gabapentin Treatment of Cannabis Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00974376
First received: September 1, 2009
Last updated: May 8, 2017
Last verified: May 2017
  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 Behavioral: Manual-guided behavioral counseling Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin Treatment of Cannabis Dependence

Resource links provided by NLM:


Further study details as provided by Barbara J. Mason, The Scripps Research Institute:

Primary Outcome Measures:
  • Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period [ Time Frame: 12 weeks ]
    Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).


Enrollment: 150
Actual Study Start Date: November 4, 2009
Study Completion Date: May 19, 2016
Primary Completion Date: May 19, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin 1200mg/day
1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Drug: gabapentin 1200mg/day
gabapentin 1200mg/day for 12 weeks
Other Name: Neurontin
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.
Other Name: Manual-guided therapy
Placebo Comparator: Placebo
1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Drug: 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.
Other Name: Manual-guided therapy

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
  More Information

Additional Information:
Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00974376     History of Changes
Other Study ID Numbers: DA026758
5R01DA026758-05 ( U.S. NIH Grant/Contract )
Study First Received: September 1, 2009
Results First Received: May 8, 2017
Last Updated: May 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Barbara J. Mason, The Scripps Research Institute:
Cannabis Treatment
Cannabis Use
Cannabis Dependence
Executive Functioning
Cognitive Deficits

Additional relevant MeSH terms:
Marijuana Abuse
Cognition Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neurocognitive Disorders
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents

ClinicalTrials.gov processed this record on August 22, 2017