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Gabapentin Treatment of Cannabis Dependence

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ClinicalTrials.gov Identifier: NCT00395044
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : February 10, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute

Tracking Information
First Submitted Date  ICMJE November 1, 2006
First Posted Date  ICMJE November 2, 2006
Results First Submitted Date  ICMJE March 15, 2013
Results First Posted Date  ICMJE February 10, 2017
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE August 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12 [ Time Frame: Week 0 and Week 12 ]
Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2006)
  • Cannabis use
  • Cannabis withdrawal
Change History Complete list of historical versions of study NCT00395044 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2016)
  • Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12 [ Time Frame: Week 0 and Week 12 ]
    The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score).
  • Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12 [ Time Frame: Week 0 and Week 12 ]
    The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score).
  • Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12 [ Time Frame: Week 0 and Week 12 ]
    The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score).
  • Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12 [ Time Frame: Week 0 and Week 12 ]
    The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score).
  • Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12 [ Time Frame: Week 0 and Week 12 ]
    The MPS is an instrument to assess the incidence of physical, psychological, social, and functioning problems that can result from cannabis dependence. The Total score ranges from 0-38 where 0=best outcome and 38=worst outcome. Change = (Week 12 score - Week 0 score).
  • Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4 [ Time Frame: Week 0 and Week 4 ]
    The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2006)
  • Sleep
  • Mood
  • Craving
  • Cannabis use consequences
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gabapentin Treatment of Cannabis Dependence
Official Title  ICMJE Gabapentin for Cannabis Withdrawal and Use
Brief Summary This is a study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Dependence
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: Gabapentin
Study Arms  ICMJE
  • Experimental: Gabapentin
    1200 mg/daily of Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    1200mg/d of Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00395044
Other Study ID Numbers  ICMJE DA020766-01
5R21DA020766-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara J. Mason, The Scripps Research Institute
Study Sponsor  ICMJE The Scripps Research Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Barbara J. Mason, Ph.D. The Scripps Research Institute- Pearson Center for Alcoholism and Addiction Research
PRS Account The Scripps Research Institute
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP