Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the
new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide
initial clinical experience with the new Depot-BNT treatment model, while providing a
rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best
behavioral platform for oral naltrexone (BNT).
The following aims will be addressed:
Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug
use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with
oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key
secondary outcomes including dysphoria, HIV risk behavior, and social functioning.
Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition,
in order to optimize Depot-BNT prior to further testing.