Gabapentin Treatment of Cannabis Dependence

NCT00974376 | Completed Phase 2 Results

• 2 other identifiers: DA0267585R01DA026758-05
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.

Conditions

Cannabis Dependence; Cannabis Withdrawal; Cognitive Deficits

Keywords

Cannabis Treatment; Cannabis Use; Cannabis Dependence; Executive Functioning; Cognitive Deficits

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Study Arms (2)

Gabapentin 1200mg/day

EXPERIMENTAL

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

Drug: gabapentin 1200mg/day; Behavioral: Manual-guided behavioral counseling

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Manual-guided behavioral counseling

Interventions

gabapentin 1200mg/day DRUG

gabapentin 1200mg/day for 12 weeks

Also known as: Neurontin

Gabapentin 1200mg/day

Placebo DRUG

1200mg/day of placebo for 12 weeks

Placebo

Manual-guided behavioral counseling BEHAVIORAL

Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.

Also known as: Manual-guided therapy

Gabapentin 1200mg/day; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Scripps Research Institute

La Jolla, California, 92037, United States

Location

Related Links

• Study Website

MeSH Terms

Conditions

Marijuana Abuse; Cognition Disorders

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Barbara Mason
• Organization: The Scripps Research Institute

mason@scripps.edu

(858) 784-7324

Study Officials

• Barbara J Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 10, 2009
• Study Start: November 4, 2009
• Primary Completion: May 19, 2016
• Study Completion: May 19, 2016
• Last Updated: June 6, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)