Employment-Based Depot Naltrexone Clinical Trial

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  Recruiting
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00684788
First received: May 23, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  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: Contingency management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Employment-Based Depot Naltrexone Clinical Trial

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
  • The time to the first missed dose of depot naltrexone

Secondary Outcome Measures:
  • Percentage of urine samples collected at the 30-day assessments that are positive for opiates
  • Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for opiates
  • Percentage of urine samples collected at the 30-day assessments that are positive for cocaine
  • Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for cocaine
  • HIV risk behaviors

Estimated Enrollment: 80
Study Start Date: May 2006
Detailed Description:

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction (N=80) 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. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone 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 that are patients in the Chemical Dependency Unit, Addiction Treatment Services, or the Behavioral Pharmacology Research Unit may be eligible for this study.

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684788

Contacts
Contact: Karly Diemer, MA 410-550-6723 kdiemer@jhmi.edu
Contact: Kylene Broadwater, BS 410-550-4943 kbroadwater@jhmi.edu

Locations
United States, Maryland
The Center for Learning and Health Recruiting
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecilia McNamara Spitznas, Ph.D., NIDA
ClinicalTrials.gov Identifier: NCT00684788     History of Changes
Other Study ID Numbers: NIDA-19497-1, R01-19497-1
Study First Received: May 23, 2008
Last Updated: May 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
opiate dependence
naltrexone
reinforcement
behavior therapy
cocaine dependence
risk reduction behavior

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced 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 September 18, 2014