Employment-Based Depot Naltrexone Clinical Trial II - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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 ] [ 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 ]

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 ] [ 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 ]

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.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	May 23, 2008
Last Updated:	May 23, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013