Clinical trial NCT00684788: Employment-Based Depot Naltrexone Clinical Trial
Official title: Employment-Based Depot Naltrexone Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Dependence
Keywords: opiate dependence
naltrexone
reinforcement
behavior therapy
cocaine dependence
risk reduction behavior
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-28
Enrollment: 35
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 over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction 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. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone 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 of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,
* reported using heroin on at least 21 of the last 30 days while in community,
* were unemployed,
* were aged 18-65 years,
* were medically approved for naltrexone
* lived in or near Baltimore, MD.

Individuals were excluded if they

* had current DSM-IV major Axis I disorders,
* had current suicidal or homicidal ideation,
* expressed interest in methadone treatment,
* were required to use opioids for medical purposes,
* earned more than $200 in taxable income over the previous 30 days,
* had physical limitations that would prevent them from using a keyboard,
* were pregnant or breastfeeding,
* had serum aminotransferase levels more than three times over normal.

Primary outcomes:
measure: Percentage of Depot Naltrexone Doses Received
timeFrame: 18 Weeks
Secondary outcomes:
measure: The Time to the First Missed Dose of Depot Naltrexone
timeFrame: 18 weeks
measure: Percentage of 30-day Assessments Urine Samples Negative for Opiates
timeFrame: 4 months
measure: Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates
timeFrame: 18 weeks
measure: Percentage of 30-day Assessments Urine Samples Negative for Cocaine
timeFrame: 4 months
measure: Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine
timeFrame: 18 weeks
measure: HIV Risk Behaviors
timeFrame: 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Center for Learning and Health
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kenneth Silverman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Everly JJ, DeFulio A, Koffarnus MN, Leoutsakos JM, Donlin WD, Aklin WM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to depot naltrexone in unemployed opioid-dependent adults: a randomized controlled trial. Addiction. 2011 Jul;106(7):1309-18. doi: 10.1111/j.1360-0443.2011.03400.x. Epub 2011 May 3.
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.