Employment-Based Depot Naltrexone Clinical Trial II

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00684775
First received: May 23, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted

May 23, 2008
May 23, 2008
May 2008
May 2010   (final data collection date for primary outcome measure)
  • The number of depot naltrexone doses that participants received [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
  • The time to the first missed dose of depot naltrexone [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Percentage of urine samples collected at the 30-day assessments that are positive for opiates [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
  • Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for cocaine [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
  • Percentage of urine samples collected at the 30-day assessments that are positive for cocaine [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
  • HIV risk behaviors [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
  • Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for opiates [ Time Frame: When all participants have completed the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Employment-Based Depot Naltrexone Clinical Trial II
Not Provided

The purpose of this study is to determine whether employment-based naltrexone treatment 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
Behavioral: employment-based reinforcement
Vivitrol, an extended-release depot formulation of naltrexone, 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.
  • 1
    Work Plus Naltrexone Prescription
    Intervention: Behavioral: employment-based reinforcement
  • Experimental: 2
    Work Plus Naltrexone Contingency
    Intervention: Behavioral: employment-based reinforcement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
Not Provided
May 2010   (final data collection date for primary outcome measure)

Applicants will be blind to the full details of the eligibility criteria.

Both
18 Years to 65 Years
No
Contact: Karly Diemer, MA 410-550-6723 kdiemer@jhmi.edu
United States
 
NCT00684775
NIDA-19497-2, R01-19497-2
Yes
Kenneth Silverman, Ph.D., Principle Investigator, Johns Hopkins University School of Medicine
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Kenneth Silverman, Ph.D. Professor, Johns Hopkins University School of Medicine
National Institute on Drug Abuse (NIDA)
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP