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The Therapeutic Workplace Intervention in Community Settings

Primary Purpose

Drug Abuse, Alcohol Abuse

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Therapeutic Workplace
Sponsored by
University of Maryland, Baltimore County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care Control

Community Therapeutic Workplace

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2013
Last Updated
May 2, 2017
Sponsor
University of Maryland, Baltimore County
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01841892
Brief Title
The Therapeutic Workplace Intervention in Community Settings
Official Title
The Therapeutic Workplace Intervention in Community Settings
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Dr. Sirgusson moved to another institution = Florida Institute of Technology in June 2013
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore County
Collaborators
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Control
Arm Type
No Intervention
Arm Title
Community Therapeutic Workplace
Arm Type
Experimental
Arm Description
Participants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers.
Intervention Type
Behavioral
Intervention Name(s)
Community Therapeutic Workplace
Intervention Description
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 Measure Information:
Title
Abstinence from alcohol, cocaine, opiates, marijuana, PCP, and amphetamine
Description
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 Outcome Measure Information:
Title
HIV Risk Behavior
Description
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
Title
Rates of community employment
Description
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 Pre-specified Outcome Measures:
Title
Adherence of community employers with Phase 2 procedures
Description
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
Title
Acceptability of intervention to participants and employers
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigurdur O Sigurdsson, Ph.D.
Organizational Affiliation
University of Maryland, Baltimore County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health, Johns Hopkins University School of Medicince, Department of Psychiatry and Behavioral Sciences
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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The Therapeutic Workplace Intervention in Community Settings

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