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Gabapentin Treatment of Cannabis Dependence

Primary Purpose

Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gabapentin 1200mg/day
Placebo
Manual-guided behavioral counseling
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Cannabis Treatment, Cannabis Use, Cannabis Dependence, Executive Functioning, Cognitive Deficits

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Scripps Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gabapentin 1200mg/day

Placebo

Arm Description

1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.

1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.

Outcomes

Primary Outcome Measures

Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).

Secondary Outcome Measures

Full Information

First Posted
September 1, 2009
Last Updated
May 8, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00974376
Brief Title
Gabapentin Treatment of Cannabis Dependence
Official Title
Gabapentin Treatment of Cannabis Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 4, 2009 (Actual)
Primary Completion Date
May 19, 2016 (Actual)
Study Completion Date
May 19, 2016 (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 clinical 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 study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits
Keywords
Cannabis Treatment, Cannabis Use, Cannabis Dependence, Executive Functioning, Cognitive Deficits

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabapentin 1200mg/day
Arm Type
Experimental
Arm Description
1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling.
Intervention Type
Drug
Intervention Name(s)
gabapentin 1200mg/day
Other Intervention Name(s)
Neurontin
Intervention Description
gabapentin 1200mg/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1200mg/day of placebo for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Manual-guided behavioral counseling
Other Intervention Name(s)
Manual-guided therapy
Intervention Description
Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
Primary Outcome Measure Information:
Title
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
Description
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
Time Frame
12 weeks

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
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

Plan to Share IPD
No
Links:
URL
http://www.pearsoncenter.org
Description
Study-related information
URL
http://alcoholismmarijuanatreatment.com/
Description
Study Website

Learn more about this trial

Gabapentin Treatment of Cannabis Dependence

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