Employment-Based Depot Naltrexone Clinical Trial II
Status: | Completed |
---|---|
Conditions: | Psychiatric, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/25/2018 |
Start Date: | May 2008 |
End Date: | April 30, 2010 |
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 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.
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.
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.
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Kenneth Silverman, Ph.D.
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