Employment-Based Depot Naltrexone Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00684788|
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : December 26, 2017
Last Update Posted : December 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Opiate Dependence||Combination Product: employment-based reinforcement||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Employment-Based Depot Naltrexone Clinical Trial|
|Actual Study Start Date :||May 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 3, 2009|
No Intervention: No Intervention
Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.
Experimental: Employment-based reinforcement
Participants were offered depot naltrexone injections and were required to take scheduled injections to work.
Combination Product: employment-based reinforcement
Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.
- Percentage of Depot Naltrexone Doses Received [ Time Frame: 18 Weeks ]The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.
- The Time to the First Missed Dose of Depot Naltrexone [ Time Frame: 18 weeks ]The number of weeks until the first missed dose of depot naltrexone
- Percentage of 30-day Assessments Urine Samples Negative for Opiates [ Time Frame: 4 months ](The number of urine samples that were negative for opiates/total number of urine samples)x 100
- Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates [ Time Frame: 18 weeks ]Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100
- Percentage of 30-day Assessments Urine Samples Negative for Cocaine [ Time Frame: 4 months ](The number of urine samples that were negative for cocaine/total number of urine samples)x 100
- Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine [ Time Frame: 18 weeks ]Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100
- HIV Risk Behaviors [ Time Frame: 4 months ]Went to a crack house
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): NCT00684788
|United States, Maryland|
|The Center for Learning and Health|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Kenneth Silverman, Ph.D.||Johns Hopkins University|