Employment-Based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1

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:
NCT00249496
First received: November 3, 2005
Last updated: May 28, 2008
Last verified: May 2008
  Purpose

This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants (N=104) who become abstinent and skilled will be randomly assigned to an Abstinence & Employment, or an Employment Only group. Participants in the Abstinence & Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.


Condition Intervention
Alcohol Use
Drug Use
Sexual Risk Behaviors
Behavioral: Contingency management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Workplace Maintenance Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of urine samples at the 30-day assessments that are negative for cocaine
  • Percentage of Monday, Wednesday and Friday urine samples that are negative for cocaine

Secondary Outcome Measures:
  • HIV risk behaviors
  • Percentage of 30-day assessment urine samples negative for opiates
  • Percentage of 30-day assessments that subjects report complete opiate abstinence
  • Percentage of Monday, Wednesday and Friday urine samples that are negative for opiates

Estimated Enrollment: 390
Study Start Date: October 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Applicants in methadone treatment may be eligible to participate in Phase 1 of the study.
  • 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: NCT00249496

Contacts
Contact: Karly N Diemer, M.A., B.S. (410)550-6723 kdiemer@jhmi.edu

Locations
United States, Maryland
The Center for Learning and Health Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kenneth Silverman, Ph.D.    410-550-2694    ksilverm@jhmi.edu   
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):
ClinicalTrials.gov Identifier: NCT00249496     History of Changes
Other Study ID Numbers: NIDA-13107-1, R01-13107-1
Study First Received: November 3, 2005
Last Updated: May 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine
opioids
contingency management
sexual risk
HIV

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on April 23, 2014