NCT00391716

Brief Summary

Gabapentin treatment for alcohol dependence

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2004

Longer than P75 for phase_2

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

February 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 10, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

5.4 years

First QC Date

October 20, 2006

Results QC Date

June 9, 2014

Last Update Submit

November 7, 2014

Conditions

AlcoholismAlcohol Dependence

Keywords

AlcoholAlcohol treatmentAlcoholismAlcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Drinking

    Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).

    12-week

Secondary Outcomes (3)

  • Mood

    12-week

  • Sleep

    12-week

  • Craving

    12-week

Study Arms (3)

gabapentin 900mg daily

EXPERIMENTAL

900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Drug: Gabapentin 900mgBehavioral: behavioral counseling

gabapentin 1800mg daily

EXPERIMENTAL

1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks

Behavioral: behavioral counselingDrug: gabapentin 1800mg

placebo daily

PLACEBO COMPARATOR

placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.

Behavioral: behavioral counselingDrug: placebo

Interventions

Gabapentin 900mgDRUG

900 mg gabapentin daily for 12 weeks

Also known as: Neurontin
gabapentin 900mg daily
behavioral counselingBEHAVIORAL

The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.

Also known as: alcoholfree.info
gabapentin 1800mg dailygabapentin 900mg dailyplacebo daily
placeboDRUG

lactose capsule compounded to mimic gabapentin capsules

Also known as: lactose capsule
placebo daily
gabapentin 1800mgDRUG

1800 mg gabapentin daily for 12 weeks

Also known as: Neurontin
gabapentin 1800mg daily

Eligibility Criteria

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

You may qualify if:

  • Men and women over age 18 with alcohol dependence

You may not qualify if:

  • Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
  • 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, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.

    PMID: 24190578RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

GabapentinBehavior TherapyLactose

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsPsychotherapyBehavioral Disciplines and ActivitiesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Results Point of Contact

Title
Dr. Barbara J. Mason
Organization
The Scripps Research Institute
mason@scripps.edu
858-784-7324

Study Officials

  • Barbara J. Mason, PhD

    The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

February 1, 2004

Primary Completion

July 1, 2009

Study Completion

February 1, 2010

Last Updated

November 10, 2014

Results First Posted

November 10, 2014

Record last verified: 2014-11

Locations

US(1)