Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
Condition: Opiate Dependence; Heroin Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Intervention: depot naltrexone; Oral Naltrexone
Intervention description: 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).; 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Opiate Dependence; Heroin Dependence; Naltrexone

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.
    

Eligibility 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.