Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
Completed · Phase 3
Conditions studied: Opiate Dependence, Heroin Dependence
In brief
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.
Key facts
- Study ID
- NCT00577408
- Run by
- New York State Psychiatric Institute
- People needed
- 60
- Starts
- 2007-09-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2017-08-25
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-60.
- 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.
- Seeking treatment for heroin dependence.
- Able to give informed consent.
You may not qualify if…
- Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
- Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
- Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- Active medical illness which might make participation hazardous, such as untreated hypertension, hepatitis with SGOT or SGPT > 3 times normal, unstable diabetes.
- 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.
- 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.
- History of allergic reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
- Chronic organic mental disorder (e.g. AIDS dementia).
- 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.
- Currently receiving any other investigational drug, or has used any other investigational drug within 30 days of study entry.
- Currently prescribed or regularly taking opiates for chronic pain or medical illness or those individuals anticipating surgical procedures which will necessitate opioid medications.
Where it is running
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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