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Gabapentin Treatment of Cannabis Dependence

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.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cannabis Dependence
Interventions Drug: Placebo
Drug: Gabapentin
Enrollment 50
Recruitment Details 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 Subjects were excluded from enrollment if they did not meet Inclusion criteria or if they met one or more of the Exclusion criteria.
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description 1200 mg/daily of Gabapentin Matched Placebo
Period Title: Overall Study
Started 25 25
Completed 7 11
Not Completed 18 14
Arm/Group Title Gabapentin Placebo Total
Hide Arm/Group Description 1200 mg/daily of Gabapentin 1200mg/d of Placebo Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
All subjects who received a randomization number and packet of medication at week 1 were included in primary and secondary outcomes
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
33.4  (8.5) 34.4  (10.8) 33.9  (9.7)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
2
   8.0%
4
  16.0%
6
  12.0%
Male
23
  92.0%
21
  84.0%
44
  88.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12
Hide Description 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.
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: ng/ml
-966.00  (1175.25) -532.81  (422.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gabapentin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .029
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12
Hide Description 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).
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.42  (1.13) 2.12  (1.50)
3.Secondary Outcome
Title Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12
Hide Description 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).
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.27  (3.07) -1.72  (2.80)
4.Secondary Outcome
Title Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12
Hide Description 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).
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.71  (1.98) 5.22  (2.36)
5.Secondary Outcome
Title Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12
Hide Description 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).
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.55  (.64) -1.46  (.77)
6.Secondary Outcome
Title Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12
Hide Description 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).
Time Frame Week 0 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.40  (2.07) -4.90  (7.09)
7.Secondary Outcome
Title Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4
Hide Description 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.
Time Frame Week 0 and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Cognitive testing was done in a subset of participants enrolled in the study, beginning with randomized subject #21 and continuing until the 50th subject was randomized. The number analyzed is the total number available for analysis that completed both the Baseline and Week 4 assessment.
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description:
1200 mg/daily of Gabapentin
Matched Placebo
Overall Number of Participants Analyzed 7 10
Mean (Standard Deviation)
Unit of Measure: scores on a scale
.28  (.50) -.20  (.31)
Time Frame 13 weeks, from baseline to week 13
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gabapentin Placebo
Hide Arm/Group Description 1200 mg/daily of Gabapentin 1200mg/d of Placebo
All-Cause Mortality
Gabapentin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gabapentin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Gabapentin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/25 (64.00%)   14/25 (56.00%) 
Gastrointestinal disorders     
Nausea *  3/25 (12.00%)  1/25 (4.00%) 
Immune system disorders     
Allergic reaction *  2/25 (8.00%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Appetite decrease *  1/25 (4.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Pain *  0/25 (0.00%)  4/25 (16.00%) 
Nervous system disorders     
Headache *  4/25 (16.00%)  6/25 (24.00%) 
Insomnia *  3/25 (12.00%)  2/25 (8.00%) 
Fatigue *  1/25 (4.00%)  2/25 (8.00%) 
Psychiatric disorders     
Depression *  2/25 (8.00%)  1/25 (4.00%) 
Irritability *  1/25 (4.00%)  2/25 (8.00%) 
Anxiety *  1/25 (4.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Cold symptoms *  2/25 (8.00%)  2/25 (8.00%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Barbara Mason
Organization: The Scripps Research Institute
Phone: (858) 784-7324
EMail: mason@scripps.edu
Layout table for additonal information
Responsible Party: Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00395044     History of Changes
Other Study ID Numbers: DA020766-01
5R21DA020766-01 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 2006
First Posted: November 2, 2006
Results First Submitted: March 15, 2013
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017