NCT00000449

Brief Summary

The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

Trial Health

80
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

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

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
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2000

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2002

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Alcoholism

Interventions

naltrexone (Revia)DRUG
cognitive behavioral therapyBEHAVIORAL
cue exposure treatmentBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Meets criteria for alcohol dependence.

You may not qualify if:

  • Current diagnosis of dependence on other substances except nicotine.
  • A history of psychosis or current psychotic symptoms.
  • Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
  • Current use of disulfiram (Antabuse).
  • Evidence of significant cerebral, renal, thyroid, or cardiac disease.
  • History of opioid abuse in the previous year.
  • History of cirrhosis, hepatocellular disease, or elevated bilirubin.
  • Females who are pregnant, nursing, or not using a reliable method of birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University, Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

NaltrexoneCognitive Behavioral Therapy

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 Activities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

March 1, 2000

Last Updated

June 24, 2005

Record last verified: 2002-08

Locations

US(1)