NCT00000456

Brief Summary

This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 1992

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1992

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

Enrollment Period

9.9 years

First QC Date

November 2, 1999

Last Update Submit

October 1, 2010

Conditions

AlcoholismAlcohol Dependence

Keywords

AlcoholismAlcohol DependenceNaltrexoneCognitive Behavioral Therapy

Interventions

naltrexone (Revia)DRUG
cognitive behavior therapyBEHAVIORAL
motivational enhancement therapyBEHAVIORAL

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification.
  • Consumes on average five standard drinks per day.
  • Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements.
  • Able to read and understand questionnaires and informed consent.
  • Lives within 50 miles of the study site.

You may not qualify if:

  • Currently meets criteria for any other psychoactive substance dependency disorder.
  • Ever abused opiates.
  • Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen.
  • Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
  • Meets criteria for dissociate disorder or eating disorders.
  • Has current suicidal or homicidal ideation.
  • Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
  • Current use of disulfiram (Antabuse).
  • Clinically significant medical problems that would impair participation or limit medication ingestion.
  • Hepatocellular disease.
  • Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
  • Have current charges pending for a violent crime.
  • Does not have a stable living situation and a reliable source of collateral reporting.
  • Has taken an opiate antagonist drug in the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Univ. of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Anton RF, Moak DH, Latham P, Waid LR, Myrick H, Voronin K, Thevos A, Wang W, Woolson R. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005 Aug;25(4):349-57. doi: 10.1097/01.jcp.0000172071.81258.04.

    PMID: 16012278RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

NaltrexoneCognitive Behavioral TherapyMotivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ray Anton, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Start

September 1, 1992

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(1)