The Therapeutic Workplace Intervention in Community Settings

NCT01841892 | Withdrawn

• 1 other identifier: 1R34DA032778-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Methadone is effective for heroin addiction, but many methadone patients continue to use cocaine. High magnitude and long-duration voucher-based abstinence reinforcement, in which participants receive vouchers exchangeable for goods and services contingent on providing drug-free biological samples, is one of the most effective treatments for drug addiction and can maintain cocaine abstinence over extended periods of time. Our research on a model Therapeutic Workplace has shown that employment-based abstinence reinforcement, in which participants must provide drug-free urine samples to access the workplace and maintain maximum pay, can maintain cocaine abstinence and reduce drug-related HIV risk behaviors over extended time periods. Our next challenge is to disseminate employment-based reinforcement for the treatment of drug addiction. The investigators propose to develop, manualize, and pilot test a community-friendly Therapeutic Workplace intervention that can be implemented widely throughout the US and elsewhere. Methadone patients who use injection or crack cocaine during methadone treatment will be invited to participate (N = 58) and randomly assigned to one of two groups: Usual Care (control) group or Community Therapeutic Workplace group. As in our prior implementations of the Therapeutic Workplace intervention, Community Therapeutic Workplace participants will enroll in Phase 1 to initiate drug abstinence and acquire job skills. Participants who initiate abstinence and acquire job skills in Phase 1 will be hired into community workplaces with collaborating employers in Phase 2. During Phase 2, employment-based abstinence reinforcement contingencies will be implemented using procedures for workplace drug and alcohol testing overseen by the US Department of Transportation. Using this system, a national provider of Drug-Free Workplace Services will arrange random drug testing and employment-based abstinence reinforcement contingencies in which employees will be required to remain drug-free to maintain employment. The investigators hypothesize that participants in the Community Therapeutic Workplace group will provide more drug-free samples, and engage in fewer HIV-risk behaviors than participants in the Usual Care group. The study will provide vital information on the acceptability of the intervention to participants and employers, and provide preliminary data on the effectiveness of the investigators procedures to maintain abstinence and promote employment.

Conditions

Drug Abuse; Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• Abstinence from alcohol, cocaine, opiates, marijuana, PCP, and amphetamine

  Abstinence from alcohol and drugs in the standard Department of Transportation 5 (cocaine, opiates, marijuana, PCP, and amphetamines) drug panel (Y/N) at each assessment. Participants will be assessed for alcohol and each drug separately, but the primary outcome measure will be abstinence from alcohol and all 5 drug.

  Once per month for first 10 study months

Secondary Outcomes (2)

• HIV Risk Behavior

  Once per month for first 10 study months, and once at 6 months follow-up after discharge

• Rates of community employment

  Once per month for study months 5-10, and once at 6 months follow-up after discharge

Other Outcomes (2)

• Adherence of community employers with Phase 2 procedures

  Weekly throughout study months 5-10

• Acceptability of intervention to participants and employers

  Weekly throughout study months 5-10

Study Arms (2)

Usual Care Control

NO INTERVENTION

Community Therapeutic Workplace

EXPERIMENTAL

Participants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers.

Behavioral: Community Therapeutic Workplace

Interventions

Community Therapeutic Workplace BEHAVIORAL

Participants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers.

Community Therapeutic Workplace

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• enrolled in methadone treatment in Baltimore
• unemployed
• provide a cocaine-positive urine sample at intake
• meet DSM IV criteria for cocaine dependence
• report using injection or crack cocaine

You may not qualify if:

• report current suicidal or homicidal ideation
• have a severe psychiatric disorder

Sponsors & Collaborators

• University of Maryland, Baltimore County: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Center for Learning and Health, Johns Hopkins University School of Medicince, Department of Psychiatry and Behavioral Sciences

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Study Officials

• Sigurdur O Sigurdsson, Ph.D.

  University of Maryland, Baltimore County

  PRINCIPAL INVESTIGATOR

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: April 19, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

US (1)