Clinical trial NCT01556425: The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
Official title: The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Dependence
Keywords: opioid use disorder
treatment
heroin
extended-release naltrexone
incentives
cotningency management
employment-based reinforcement
therapeutic workplace
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Percent of Weekly Urine Samples Negative for Opiates
timeFrame: 24 weeks
Secondary outcomes:
measure: Percent of Weekly Urine Samples Negative for Cocaine
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Center for Learning and Health
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kenneth Silverman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: