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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:
NCT00395044
First received: November 1, 2006
Last updated: December 19, 2016
Last verified: December 2016
Results First Received: March 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cannabis Dependence
Interventions: Drug: Placebo
Drug: Gabapentin

  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
50 subjects were recruited. An initial phone screen was conducted followed by an in-person clinical screening and interview in the research laboratory.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded from enrollment if they did not meet Inclusion criteria or if they met one or more of the Exclusion criteria.

Reporting Groups
  Description
Gabapentin 1200 mg/daily of Gabapentin
Placebo Matched Placebo

Participant Flow:   Overall Study
    Gabapentin   Placebo
STARTED   25   25 
COMPLETED   7   11 
NOT COMPLETED   18   14 



  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.
All subjects who received a randomization number and packet of medication at week 1 were included in primary and secondary outcomes

Reporting Groups
  Description
Gabapentin 1200 mg/daily of Gabapentin
Placebo 1200mg/d of Placebo
Total Total of all reporting groups

Baseline Measures
   Gabapentin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      25 100.0%      25 100.0%      50 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 33.4  (8.5)   34.4  (10.8)   33.9  (9.7) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2   8.0%      4  16.0%      6  12.0% 
Male      23  92.0%      21  84.0%      44  88.0% 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12   [ Time Frame: Week 0 and Week 12 ]

2.  Secondary:   Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12   [ Time Frame: Week 0 and Week 12 ]

3.  Secondary:   Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12   [ Time Frame: Week 0 and Week 12 ]

4.  Secondary:   Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12   [ Time Frame: Week 0 and Week 12 ]

5.  Secondary:   Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12   [ Time Frame: Week 0 and Week 12 ]

6.  Secondary:   Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12   [ Time Frame: Week 0 and Week 12 ]

7.  Secondary:   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 ]


  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


Publications of Results:

Responsible Party: Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00395044     History of Changes
Other Study ID Numbers: DA020766-01
5R21DA020766-01 ( US NIH Grant/Contract Award Number )
Study First Received: November 1, 2006
Results First Received: March 15, 2013
Last Updated: December 19, 2016