NCT00006449

Brief Summary

The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.

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 2000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2000

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

May 12, 2010

Status Verified

May 1, 2010

First QC Date

November 6, 2000

Last Update Submit

May 11, 2010

Conditions

Alcoholism

Interventions

naltrexone (Revia)DRUG
broad spectrum treatmentBEHAVIORAL
motivational enhancement therapyBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment
  • Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.
  • Must be fluent in English.
  • Women of childbearing potential must have a negative pregnancy test.

You may not qualify if:

  • Severe hepatic disease or a liver function test greater than 4 times normal.
  • Opiate use in the last 14 days or a history of opioid dependence in the past year.
  • Pregnant or lactating females who are not using a reliable method of birth control.
  • Inability to follow medication instructions and safety precautions.
  • Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana dependence.
  • Use of medications intended to decrease drinking.
  • Meets criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatric Research, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

NaltrexoneMotivational 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 CompoundsDirective CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2000

First Posted

November 7, 2000

Study Start

September 1, 2000

Study Completion

July 1, 2006

Last Updated

May 12, 2010

Record last verified: 2010-05

Locations

US(1)