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Managing Alcoholism in People Who Do Not Respond to Naltrexone

NCT00115037 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2019-09-18

Study results available
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Summary

This is a study involving treatment for alcohol dependence (alcoholism). The study will combine motivational enhancement therapy and cognitive behavioral therapy (combined behavioral intervention, or CBI) and tests the benefits of continued/discontinued treatment with naltrexone in a randomized placebo-controlled trial. CBI may have advantages in motivating patients to greater medication adherence and may address psychosocial factors that may limit the effects of naltrexone.

Conditions

  • Alcoholism

Interventions

DRUG

Naltrexone

100mg/day, up to 8 weeks during Phase 1, 16 weeks in phase 2.

DRUG

placebo

placebo comparer for 16 weeks in phase 2.

BEHAVIORAL

Medication Management (MM)

Brief manual-based therapy for up to 8 weeks during phase 1, 16 during phase 2.

BEHAVIORAL

Combined Behavioral Intervention (CBI)

45-60 minute sessions with a certified therapist focused on resolving ambivalence and skill building. Number of sessions guided by achievement of goals identified within treatment plan; minimum 9, maximum 20 sessions over 16 weeks.

BEHAVIORAL

Telephone Counseling

Bi-weekly telephone calls lasting 15-20 minutes focused on the same content as MM.

Sponsors & Collaborators

Principal Investigators

  • David W. Oslin, M.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-04-30
Completion
2008-07-31

Countries

  • United States

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115037 on ClinicalTrials.gov