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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Drug Abuse, Alcohol Abuse
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care Control | No intervention | Not described |
| 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. Receives: Behavioral: Community Therapeutic Workplace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Why it stopped: Dr. Sirgusson moved to another institution = Florida Institute of Technology in June 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore County
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Sigurdur O Sigurdsson, Ph.D., Principal investigator, University of Maryland, Baltimore County
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Workplace Intervention in Community Settings
- ClinicalTrials.gov ID
- NCT01841892
- Acronym / sponsor ID
- 1R34DA032778-01A1
- Conditions
- Drug Abuse, Alcohol Abuse
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Dr. Sirgusson moved to another institution = Florida Institute of Technology in June 2013
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, Baltimore CountyUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | No intervention | – |
| Community Therapeutic Workplace | Experimental | Behavioral: Community Therapeutic WorkplaceParticipants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (2 listed)
- report current suicidal or homicidal ideation
- have a severe psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Therapeutic WorkplaceParticipants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers. | Behavioural | Community Therapeutic Workplace |
Primary outcome
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.
2 secondary outcomes
HIV Risk Behavior
Time frame: Once per month for first 10 study months, and once at 6 months follow-up after discharge
Rates of community employment
Time frame: Once per month for study months 5-10, and once at 6 months follow-up after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigurdur O Sigurdsson, Ph.D. principal investigator
University of Maryland, Baltimore County
1 site in 1 country: see every site and its status.
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.