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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by (Responsible Party):
Kenneth Silverman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00249496
First received: November 3, 2005
Last updated: October 25, 2016
Last verified: October 2016
  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
Risk Behavior
Sexual Behavior
Behavioral: Contingency management
Behavioral: Employment Only

Study Type: Interventional
Study Design: Allocation: Randomized
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 Johns Hopkins University:

Primary Outcome Measures:
  • Percentage of Monthly Urine Samples That Are Negative for Cocaine [ Time Frame: 1 year ]
    The percentage of urine samples collected at monthly assessments that are negative for cocaine.


Enrollment: 128
Study Start Date: October 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Employment Only
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Behavioral: Employment Only
Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.
Experimental: Contingency Management
Participants in the Contingency Management 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.
Behavioral: Contingency management
Participants in the Contingency Management 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • Unemployed
  • Provided a urine sample at intake with a detectable concentration of cocaine metabolite or provided a cocaine positive sample during regular urinalysis testing at a methadone maintenance program
  • Met DSM-IV criteria for cocaine dependence
  • Were receiving welfare benefits in Baltimore, MD
  • Received a score of less than or equal to 80% correct on a reading assessment

Exclusion Criteria

  • Being at imminent risk for suicide
  • Reported hallucinations
  • Being incarcerated or otherwise under constant monitoring
  • Earned less than or equal to $200 in unreported taxable income from legal activity in the previous month
  • Having physical limitations that prevented typing
  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: NCT00249496

Locations
United States, Maryland
The Center for Learning and Health
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Kenneth Silverman
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth Silverman, Ph.D, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00249496     History of Changes
Other Study ID Numbers: NIDA-13107-1
R01DA013107-01 ( US NIH Grant/Contract Award Number )
R01-13107-1
Study First Received: November 3, 2005
Results First Received: August 31, 2016
Last Updated: October 25, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The results were published in a peer-reviewed journal.

Keywords provided by Johns Hopkins University:
cocaine
opioids
contingency management
sexual risk
HIV

ClinicalTrials.gov processed this record on March 23, 2017