Employment-Based Depot Naltrexone Clinical Trial
Status: | Completed |
---|---|
Conditions: | Psychiatric, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 12/27/2017 |
Start Date: | May 2006 |
End Date: | May 3, 2009 |
The purpose of this study is to determine whether employment-based naltrexone treatment
proves effective in promoting depot naltrexone adherence and drug abstinence.
proves effective in promoting depot naltrexone adherence and drug abstinence.
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.
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.
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.
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