Employment-Based Depot Naltrexone Clinical Trial II
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|ClinicalTrials.gov Identifier: NCT00684775|
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : December 26, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence||Combination Product: Work Plus Naltrexone Contingency||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Employment-Based Depot Naltrexone Clinical Trial II|
|Actual Study Start Date :||May 2008|
|Actual Primary Completion Date :||April 30, 2010|
|Actual Study Completion Date :||April 30, 2010|
No Intervention: Work Plus Naltrexone Prescription
Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
Experimental: Work Plus Naltrexone Contingency
Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.
Combination Product: Work Plus Naltrexone Contingency
Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were 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 earned access to working and earning salary by taking depot naltrexone injections once per month.
Other Name: contingency management
- Naltrexone Injections Received [ Time Frame: 24 weeks ]The percentage of depot naltrexone doses that participants received
- Time to the First Missed Dose [ Time Frame: 24 weeks ]The time to the first missed dose of depot naltrexone
- Percentage of 30-day Urine Samples Negative for Opiates [ Time Frame: Collected every 30 days for 150 days ]Percentage of urine samples collected at the 30-day assessments that are negative for opiates
- Percentage of M-W-F Samples Negative for Cocaine [ Time Frame: Collected every Monday, Wednesday and Friday for 24 weeks ]Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
- Average Percentage of 30-day Urine Samples Negative for Cocaine [ Time Frame: Collected every 30 days for 150 days ]The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
- HIV Risk Behaviors [ Time Frame: 24 weeks ]behaviors that place participants at risk for acquiring or transmitting HIV infection
- Percentage of M,W,F Urine Samples Negative for Opiates [ Time Frame: Collected every Monday, Wednesday and Friday for 24 weeks ]Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684775
|United States, Maryland|
|The Center for Learning and Health|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Kenneth Silverman, Ph.D.||Professor, Johns Hopkins University School of Medicine|