Phase 2
N=150
Gabapentin Treatment of Cannabis Dependence
Cannabis Dependence · Cannabis Withdrawal · Cognitive Deficits
Bottom Line
View on ClinicalTrials.gov: NCT00974376 ↗Enrolled (actual)
150
Serious AEs
0.3%
Results posted
Jun 2017
Primary outcome: Primary: Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period — 11.22; 8.00; 12.48; 9.93 percentage of negative UDS
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- gabapentin 1200mg/day (Drug); Placebo (Drug); Manual-guided behavioral counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Scripps Research Institute
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period |
11.22; 8.00; 12.48; 9.93 | — |
Summary
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Eligibility Criteria
Inclusion Criteria
- Males or females from 18-65 years of age
- Meets DSM IV criteria for current cannabis dependence
- Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
- Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
- At least a 2-year history of regular MJ use
Exclusion Criteria
- Abstinent from cannabis more than 2 days at the time of randomization
- Active suicidal ideation
- Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
- Significant medical disorders that will increase potential risk or interfere with study participation,
- Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
- Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
- Inability to understand and/or comply with the provisions of the protocol and consent form
- Treatment with an investigational drug during the previous month
- Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
- Ongoing treatment with medications that may affect study outcomes
Data sourced from ClinicalTrials.gov (NCT00974376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.