Back to resultsGabapentin Treatment of Cannabis Dependence
Primary Purpose
Cannabis Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Dependence focused on measuring Cannabis treatment, marijuana treatment
Eligibility Criteria
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
Sites / Locations
- The Scripps Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
1200 mg/daily of Gabapentin
1200mg/d of Placebo
Outcomes
Primary Outcome Measures
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at 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.
Secondary Outcome Measures
Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 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
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
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
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
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
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.
Full Information
NCT ID
NCT00395044
First Posted
November 1, 2006
Last Updated
December 19, 2016
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00395044
Brief Title
Gabapentin Treatment of Cannabis Dependence
Official Title
Gabapentin for Cannabis Withdrawal and Use
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
Cannabis treatment, marijuana treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
1200 mg/daily of Gabapentin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1200mg/d of Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Primary Outcome Measure Information:
Title
Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12
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
Secondary Outcome Measure Information:
Title
Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12
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
Title
Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12
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
Title
Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12
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
Title
Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12
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
Title
Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12
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
Title
Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute- Pearson Center for Alcoholism and Addiction Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22373942
Citation
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.
Results Reference
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Gabapentin Treatment of Cannabis Dependence
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