Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Opiate DependenceHeroin Dependence
Interventions
DRUG

depot naltrexone

On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).

DRUG

Oral Naltrexone

For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.

Trial Locations (1)

10032

New York State Psychiatric Institute, New York

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

New York State Psychiatric Institute

OTHER

NCT00577408 - Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone | Biotech Hunter | Biotech Hunter