Managing Alcoholism in People Who Do Not Respond to Naltrexone

PHASE4CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

April 30, 2008

Study Completion Date

July 31, 2008

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.

Trial Locations (1)

19104

University of Pennsylvania Treatment Research Center, Chestnut Street, Philadelphia

All Listed Sponsors
lead

University of Pennsylvania

OTHER

NCT00115037 - Managing Alcoholism in People Who Do Not Respond to Naltrexone | Biotech Hunter | Biotech Hunter