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Drug AbuseNCT01841892

The Therapeutic Workplace Intervention in Community Settings

A study testing Community Therapeutic Workplace in people with Drug Abuse and Alcohol Abuse, run by University of Maryland, Baltimore County at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Drug Abuse, Alcohol Abuse
What is being tested?
Community Therapeutic Workplace
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2013to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Learning and Health, Johns Hopkins University School of Medicince, Department of Psychiatry and Behavioral Sciences

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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.

Being tested
Community Therapeutic Workplace
Medical subject headings
Substance-Related Disorders, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Therapeutic WorkplaceBehavioural

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

Study groups in NCT01841892
Study groupRoleWhat they receive
Usual Care ControlNo interventionNot described
Community Therapeutic WorkplaceExperimentalParticipants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers.
Receives: Behavioral: Community Therapeutic Workplace

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Once per month for first 10 study months

Secondary outcomes (2)
  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2015 (estimated)
  4. Study completionMar 2015 (estimated)

Why it stopped: Dr. Sirgusson moved to another institution = Florida Institute of Technology in June 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01841892
Sponsor's protocol ID
1R34DA032778-01A1
Status last verified
May 2017
First submitted
19 Apr 2013
Last updated
5 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Community Therapeutic Workplace in people with Drug Abuse and Alcohol Abuse, run by University of Maryland, Baltimore County at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abstinence from alcohol, cocaine, opiates, marijuana, PCP, and amphetamine (time frame: Once per month for first 10 study months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.

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