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The Therapeutic Workplace Intervention in Community Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841892
Recruitment Status : Withdrawn (Dr. Sirgusson moved to another institution = Florida Institute of Technology in June 2013)
First Posted : April 29, 2013
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
University of Maryland, Baltimore County

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.

Condition or disease Intervention/treatment Phase
Drug Abuse Alcohol Abuse Behavioral: Community Therapeutic Workplace Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Therapeutic Workplace Intervention in Community Settings
Study Start Date : April 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Arm Intervention/treatment
No Intervention: Usual Care Control
Experimental: Community Therapeutic Workplace
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
Participants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers.




Primary Outcome Measures :
  1. Abstinence from alcohol, cocaine, opiates, marijuana, PCP, and amphetamine [ Time Frame: Once per month for first 10 study months ]
    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.


Secondary Outcome Measures :
  1. HIV Risk Behavior [ Time Frame: Once per month for first 10 study months, and once at 6 months follow-up after discharge ]
    The outcome measure for risky HIV injection behaviors will be sharing needles/syringes without disinfecting, sharing cookers/cottons/rinse water, or sharing the drug solution in the past 30 days (Y/N). For risky HIV sex behaviors, the outcome measure will be always practicing safe sex in the past 30 days (Y/N), defined as abstaining from sex or 100% use of condoms during vaginal or anal sex.

  2. Rates of community employment [ Time Frame: Once per month for study months 5-10, and once at 6 months follow-up after discharge ]
    We will collect data on participant employment outcomes (types of jobs, salaries, benefits, etc.) and confirm employment with employers.


Other Outcome Measures:
  1. Adherence of community employers with Phase 2 procedures [ Time Frame: Weekly throughout study months 5-10 ]
    We will monitor whether employers notify participants of testing days. We will also monitor employer implementation of prescribed procedures following positive breath or urine samples.

  2. Acceptability of intervention to participants and employers [ Time Frame: Weekly throughout study months 5-10 ]
    We will monitor acceptances of job offers, and durations of employment. We will monitor the number of job offers to participants and the number of terminations not due to drug use.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841892


Locations
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United States, Maryland
Center for Learning and Health, Johns Hopkins University School of Medicince, Department of Psychiatry and Behavioral Sciences
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
University of Maryland, Baltimore County
Johns Hopkins University
Investigators
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Principal Investigator: Sigurdur O Sigurdsson, Ph.D. University of Maryland, Baltimore County

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Responsible Party: University of Maryland, Baltimore County
ClinicalTrials.gov Identifier: NCT01841892    
Other Study ID Numbers: 1R34DA032778-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders