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Gabapentin Treatment of Cannabis Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974376
First Posted: September 10, 2009
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
Results First Submitted: May 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cannabis Dependence
Cannabis Withdrawal
Cognitive Deficits
Interventions: Drug: gabapentin 1200mg/day
Drug: Placebo
Behavioral: Manual-guided behavioral counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gabapentin 1200mg/Day 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
Placebo Matched placebo given in conjunction with standardized manual-guided behavioral counseling.

Participant Flow:   Overall Study
    Gabapentin 1200mg/Day   Placebo
STARTED   75   75 
COMPLETED   41   42 
NOT COMPLETED   34   33 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Gabapentin 1200mg/Day 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
Placebo Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
Total Total of all reporting groups

Baseline Measures
   Gabapentin 1200mg/Day   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.99  (10.68)   34.53  (11.99)   34.76  (11.32) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  30.7%      27  36.0%      50  33.3% 
Male      52  69.3%      48  64.0%      100  66.7% 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Barbara Mason
Organization: The Scripps Research Institute
phone: (858) 784-7324
e-mail: mason@scripps.edu



Responsible Party: Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00974376     History of Changes
Other Study ID Numbers: DA026758
5R01DA026758-05 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2009
First Posted: September 10, 2009
Results First Submitted: May 8, 2017
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017