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Employment-Based Depot Naltrexone Clinical Trial II

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684775
First Posted: May 28, 2008
Last Update Posted: October 19, 2017
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.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Condition Intervention Phase
Opiate Dependence Behavioral: employment-based reinforcement Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • The number of depot naltrexone doses that participants received [ Time Frame: When all participants have completed the study ]
  • The time to the first missed dose of depot naltrexone [ Time Frame: When all participants have completed the study ]

Secondary Outcome Measures:
  • Percentage of urine samples collected at the 30-day assessments that are positive for opiates [ Time Frame: When all participants have completed the study ]
  • 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 ]
  • Percentage of urine samples collected at the 30-day assessments that are positive for cocaine [ Time Frame: When all participants have completed the study ]
  • HIV risk behaviors [ Time Frame: When all participants have completed the study ]
  • 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 ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Work Plus Naltrexone Prescription
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.
Experimental: 2
Work Plus Naltrexone Contingency
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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Applicants will be blind to the full details of the eligibility criteria.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Karly Diemer, MA 410-550-6723 kdiemer@jhmi.edu

Locations
United States, Maryland
The Center for Learning and Health Not yet recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Kenneth Silverman, Ph.D.         
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Professor, Johns Hopkins University School of Medicine
  More Information

Responsible Party: Kenneth Silverman, Ph.D., Principle Investigator, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00684775     History of Changes
Other Study ID Numbers: NIDA-19497-2
R01-19497-2
First Submitted: May 23, 2008
First Posted: May 28, 2008
Last Update Posted: October 19, 2017
Last Verified: May 2008

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents