The Therapeutic Workplace Intervention in Community Settings

Alcohol Abuse Clinical Trial

Official title:

The Therapeutic Workplace Intervention in Community Settings

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01841892
• Other study ID #: 1R34DA032778-01A1
• Status: Withdrawn
• Phase: N/A
• First received: April 19, 2013
• Last updated: May 2, 2017
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2017
• Source: University of Maryland, Baltimore County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Drug Abuse
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Learning and Health, Johns Hopkins University School of Medicince, Department of Psychiatry and Behavioral Sciences	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore County	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Weekly throughout study months 5-10
Other	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.	Weekly throughout study months 5-10
Primary	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	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.	Once per month for first 10 study months, and once at 6 months follow-up after discharge
Secondary	Rates of community employment	We will collect data on participant employment outcomes (types of jobs, salaries, benefits, etc.) and confirm employment with employers.	Once per month for study months 5-10, and once at 6 months follow-up after discharge