Clinical trial NCT00684775: Employment-Based Depot Naltrexone Clinical Trial II
Official title: Employment-Based Depot Naltrexone Clinical Trial II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Dependence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-28
Enrollment: 38
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: The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Detailed description: A randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Eligibility criteria: Individuals were eligible if they:

* met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,
* reported using heroin at least 21 of the last 30 days while living in the community,
* were unemployed,
* were 18-65 years old,
* were medically approved for naltrexone,
* lived in or near Baltimore, MD.

Individuals were excluded if they:

* were pregnant or breastfeeding,
* had serum aminotransferase levels over three times normal,
* had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation,
* expressed interest in methadone treatment,
* were required to use opioids for medical purposes,
* earned over $200 in taxable income over the previous 30 days,
* had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.

Primary outcomes:
measure: Naltrexone Injections Received
timeFrame: 24 weeks
measure: Time to the First Missed Dose
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of 30-day Urine Samples Negative for Opiates
timeFrame: Collected every 30 days for 150 days
measure: Percentage of M-W-F Samples Negative for Cocaine
timeFrame: Collected every Monday, Wednesday and Friday for 24 weeks
measure: Average Percentage of 30-day Urine Samples Negative for Cocaine
timeFrame: Collected every 30 days for 150 days
measure: HIV Risk Behaviors
timeFrame: 24 weeks
measure: Percentage of M,W,F Urine Samples Negative for Opiates
timeFrame: Collected every Monday, Wednesday and Friday for 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Center for Learning and Health
state: Maryland
Study officials:
affiliation: Professor, Johns Hopkins University School of Medicine
name: Kenneth Silverman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeFulio A, Everly JJ, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial. Drug Alcohol Depend. 2012 Jan 1;120(1-3):48-54. doi: 10.1016/j.drugalcdep.2011.06.023. Epub 2011 Jul 22.