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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Injection heroin use is a chronic problem that fuels the transmission of HIV/AIDS through
      risky injection behaviors. Methadone and buprenorphine can reduce heroin use and risky
      injection behavior; however, they have abuse potential, produce physical dependence, can
      produce lethal overdose, are highly regulated, and some patients simply do not want agonist
      treatment. Opiate detoxifications can serve as an alternative to agonist treatment, but many
      injection drug users relapse to heroin use and resume risky injection behaviors after
      detoxification. Vivitrol®, an extended release formulation of naltrexone, was recently
      approved by the FDA for the treatment of opioid dependence, but its clinical utility is
      uncertain given the reluctance of many opioid-dependent adults to maintain its long-term use,
      and the fact that some patients continue to use opiates while under naltrexone blockade. The
      investigators research in the first period of this grant showed that employment-based
      reinforcement can be highly effective in promoting long-term adherence to Vivitrol®.
      Employment-based reinforcement may be ideally suited to address the limitations of extended
      release naltrexone by capitalizing on its potential to simultaneously reinforce naltrexone
      adherence and opiate abstinence. This grant will evaluate the effectiveness of
      employment-based reinforcement to simultaneously promote high rates of Vivitrol® adherence
      and increase opiate abstinence. After an opioid detoxification and induction onto oral
      naltrexone, participants will be invited to attend the Therapeutic Workplace for 24 weeks
      (where they can work and earn wages) and will be randomly assigned to one of four groups that
      will differ in whether they receive Vivitrol®, employment-based opiate abstinence
      reinforcement, both or neither. Participants in Vivitrol® conditions will be required to take
      scheduled injections to work and earn wages. Participants exposed to opiate abstinence
      reinforcement will receive a temporary decrease in their workplace pay if they fail to
      provide an opiate-free urine sample. The study will assess the effects of the interventions
      on weekly opiate urinalysis results, and on measures of injection drug use and cocaine use.
      If this study shows that the combined use of Vivitrol® and employment-based reinforcement of
      adherence and opiate abstinence is effective in maintaining long-term opiate abstinence, this
      model of employment-based addiction pharmacotherapy could be integrated into community
      workplaces to disseminate the effective use of Vivitrol®; it could be used to enhance the
      utility of other new antagonist-like addiction medications; and it could provide an effective
      means of reducing injection drug use in individuals who persist in injecting heroin and
      exposing themselves and others to the risk of acquiring or transmitting HIV infection due to
      their continued injection drug use and risky injection behaviors.
    

Intervention name(s): Vivitrol; Employment-based opiate abstinence reinforcement; Usual Care Control
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid use disorder; treatment; heroin; extended-release naltrexone; incentives; cotningency management; employment-based reinforcement; therapeutic workplace