Overview

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:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Naltrexone
Criteria
Inclusion Criteria:

1. Age 18-60.

2. Meets DSM-IV criteria for current opiate dependence disorder of at least six months
duration, supported by a positive urine for opiates and a positive naloxone challenge
test if the diagnosis is unclear. If participating as an outpatient only, recent
opiate dependence must be confirmed by clinical history and/or communication with
former treatment provider.

3. Seeking treatment for heroin dependence.

4. Able to give informed consent.

Exclusion Criteria:

1. Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per
week).

2. Maintenance on, or regular use of buprenorphine or other long-acting narcotic
agonists.

3. Pregnancy, lactation, or failure in a sexually active woman to use adequate
contraceptive methods.

4. Active medical illness which might make participation hazardous, such as untreated
hypertension, hepatitis with SGOT or SGPT > 3 times normal, unstable diabetes.

5. Active psychiatric disorder which might interfere with participation or make
participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania
or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts
within the past year.

6. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal.
Other substance use diagnoses are not exclusionary. Multiple substance use is common
in this population, and such an exclusion would rule out a large proportion of the
population and limit the generalizability of the study.

7. History of allergic reaction to buprenorphine, naltrexone, naloxone, clonidine, or
clonazepam.

8. Chronic organic mental disorder (e.g. AIDS dementia).

9. History of accidental drug overdose in the last 3 years as defined as an episode of
opioid-induced unconsciousness or incapacitation, whether or not medical treatment was
sought or received.

10. Currently receiving any other investigational drug, or has used any other
investigational drug within 30 days of study entry.

11. Currently prescribed or regularly taking opiates for chronic pain or medical illness
or those individuals anticipating surgical procedures which will necessitate opioid
medications.