The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Vivitrol; Employment-based opiate abstinence reinforcement; Usual Care Control
Intervention description: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.; This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.; Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: opioid use disorder; treatment; heroin; extended-release naltrexone; incentives; cotningency management; employment-based reinforcement; therapeutic workplace

Summary:

      In this 5-year study, the investigators propose to evaluate the separate and combined effects
      of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and
      employment-based reinforcement of opiate abstinence in promoting opiate abstinence and
      reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug
      users.
    

Eligibility criteria:

        Inclusion Criteria:

          1. meet the DSM-IV criteria for opioid dependence,

          2. report using heroin at least 21 of the last 30 days while living in the community,

          3. are unemployed,

          4. are 18-65 years old,

          5. are medically approved for naltrexone,

          6. live in or near Baltimore, MD.

        Exclusion Criteria:

          1. have current DSM-IV major Axis I disorders

          2. have current suicidal or homicidal ideation

          3. express interest in methadone treatment

          4. are required to use opioids for medical purposes

          5. earned over $200 in taxable income over the previous 30 days while living in the
             community

          6. have physical limitations that prevent them from using a keyboard

          7. are pregnant or breastfeeding

          8. have serum aminotransferase levels over three times normal

          9. have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose,
             or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;

         10. are participating in any other clinical study.