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WithdrawnNCT01841892Updated May 5, 2017

The Therapeutic Workplace Intervention in Community Settings

An interventional study of Community Therapeutic Workplace in Drug Abuse and Alcohol Abuse, sponsored by University of Maryland, Baltimore County. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-05.

Sponsored by University of Maryland, Baltimore County · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Dr. Sirgusson moved to another institution = Florida Institute of Technology in June 2013
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Abuse
  • Alcohol Abuse
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

Browse Alcoholism studies →

Lead sponsor

University of Maryland, Baltimore County is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • report current suicidal or homicidal ideation
  • have a severe psychiatric disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralCommunity 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.

06

What researchers measure

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.

    Time frame: Once per month for first 10 study months

Secondary outcomes

  1. HIV Risk Behavior

    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.

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

  2. Rates of community employment

    We will collect data on participant employment outcomes (types of jobs, salaries, benefits, etc.) and confirm employment with employers.

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

Other outcomes

  1. Adherence of community employers with Phase 2 procedures

    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.

    Time frame: Weekly throughout study months 5-10

  2. Acceptability of intervention to participants and employers

    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.

    Time frame: Weekly throughout study months 5-10

07

Study locations

1 site
  • Center for Learning and Health, Johns Hopkins University School of Medicince, Department of Psychiatry and Behavioral Sciences
    Baltimore, Maryland 21224, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01841892
Lead sponsor
University of Maryland, Baltimore County
Collaborators
Johns Hopkins University
Responsible party
Sponsor
First posted
Apr 29, 2013
Start date
Apr 2013
Primary completion
Mar 2015 (estimated)
Completion
Mar 2015 (estimated)
Last update
May 5, 2017

Study contacts

Sigurdur O Sigurdsson, Ph.D.
principal investigator · University of Maryland, Baltimore County

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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