NCT00249496

Brief Summary

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

December 16, 2016

Completed
Last Updated

September 18, 2017

Status Verified

August 1, 2017

Enrollment Period

3.8 years

First QC Date

November 3, 2005

Results QC Date

August 31, 2016

Last Update Submit

August 18, 2017

Conditions

Alcohol UseDrug UseRisk BehaviorSexual Behavior

Keywords

cocaineopioidscontingency managementsexual riskHIV

Outcome Measures

Primary Outcomes (1)

  • Percentage of Monthly Urine Samples That Are Negative for Cocaine

    The percentage of urine samples collected at monthly assessments that are negative for cocaine.

    1 year

Secondary Outcomes (4)

  • Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Cocaine

    1 year

  • Percentage of 30-day Assessment Urine Samples Negative for Opiates

    1 year

  • Percentage of Monday, Wednesday and Friday Urine Samples That Are Negative for Opiates

    1 year

  • HIV Risk Behaviors

    1 year

Study Arms (2)

Employment Only

ACTIVE COMPARATOR

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

Contingency Management

EXPERIMENTAL

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

Interventions

Contingency managementBEHAVIORAL

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.

Contingency Management
Employment OnlyBEHAVIORAL

Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.

Employment Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

  • DeFulio A, Donlin WD, Wong CJ, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: a randomized controlled trial. Addiction. 2009 Sep;104(9):1530-8. doi: 10.1111/j.1360-0443.2009.02657.x.

    PMID: 19686522RESULT

  • DeFulio A, Silverman K. Employment-based abstinence reinforcement as a maintenance intervention for the treatment of cocaine dependence: post-intervention outcomes. Addiction. 2011 May;106(5):960-7. doi: 10.1111/j.1360-0443.2011.03364.x. Epub 2011 Mar 7.

    PMID: 21226886DERIVED

MeSH Terms

Conditions

Alcohol DrinkingRisk-TakingSexual Behavior

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Results Point of Contact

Title
Dr. Kenneth Silverman
Organization
Johns Hopkins School of Medicine: Department of Psychiatry
ksilverm@jhmi.edu
410-550-2694

Study Officials

  • Kenneth Silverman, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

October 1, 2003

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

September 18, 2017

Results First Posted

December 16, 2016

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

The results were published in a peer-reviewed journal.

Locations

US(1)