NCT00395044

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

1.9 years

First QC Date

November 1, 2006

Results QC Date

March 15, 2013

Last Update Submit

December 19, 2016

Conditions

Cannabis Dependence

Keywords

Cannabis treatmentmarijuana treatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    Week 0 and Week 12

Secondary Outcomes (6)

  • Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12

    Week 0 and Week 12

  • Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12

    Week 0 and Week 12

  • Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12

    Week 0 and Week 12

  • Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12

    Week 0 and Week 12

  • Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12

    Week 0 and Week 12

  • +1 more secondary outcomes

Study Arms (2)

Gabapentin

EXPERIMENTAL

1200 mg/daily of Gabapentin

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

1200mg/d of Placebo

Drug: Placebo

Interventions

PlaceboDRUG

Placebo

Placebo
GabapentinDRUG
Gabapentin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Scripps Research Institute

La Jolla, California, 92037, United States

Location

Related Publications (1)

  • 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.

    PMID: 22373942RESULT

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino 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- Pearson Center for Alcoholism and Addiction Research

    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
Professor

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2016-12

Locations

US(1)