A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and increasing abstinence in unemployed, out-of-treatment injection heroine users.

Detailed Description
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A randomized study is planned for 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting methadone treatment and abstinence in unemployed injection drug users. Participants will be recruited through street outreach, at agencies that serve the target populations, and informal word-of-mouth referrals. Participants will be invited to attend the workplace and to enroll in the methadone treatment. To engage participants in the workplace, they will be allowed to work independent of whether they enroll in methadone treatment and independent of their drug use. The workplace participants (N=162) will be randomly assigned to three groups. The Usual Care Control participants will be allowed to work independent of their methadone use or urinalysis results. The Methadone Contingency participants will be required to take methadone to attend work, and will receive a brief pay decrease for failing to take their medication. The Methadone & Abstinence Contingency participants will be required to take their medication in order to attend work, as well as receive a brief pay decrease for any positive urine samples for both cocaine and methadone.

Official Title
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A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Conditions
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Opiate Dependence

Intervention / Treatment
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* Behavioral: methadone contingency
* Behavioral: Methadone & Abstinence Contingency


Participation Criteria
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Eligibility Criteria
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Individuals were eligible if they were: at least 18 years old, reported injection drug use in the past 30 days, met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence, reported using heroin at least 21 out of the past 30 days, provided an opiate-positive urine sample, showed visible signs of injection drug use (i.e., track marks), reported not receiving substance abuse treatment in the past 30 days, lived in Baltimore, and were unemployed. Participants were excluded if they had current severe psychiatric disorders or chronic medical conditions that would interfere with their ability to participate in the workplace, reported current suicidal or homicidal ideation, had physical limitations that would prevent them from using a keyboard, had medical insurance coverage (as this would disqualify them from receiving interim methadone treatment), were pregnant or breastfeeding, or were currently considered a prisoner. Eligible participants were invited to participate in a 4-week induction. Participants who attended the workplace for at least five minutes on two out of five workdays in the last week of induction were randomly assigned to one of three conditions and were invited to attend the workplace for an additional 26 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care Control<br>Participants in this group were offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They were offered the methadone treatment but were not required to join in order to gain access to the workplace. | |
| Experimental: Methadone Contingency Group<br>Participants in this group were allowed to work and earn wages as long as they enrolled in the methadone treatment and continued to take does of methadone consistently (employment-based reinforcement). | Behavioral: methadone contingency<br>* Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.<br>|
| Experimental: Methadone & Abstinence Contingency<br>Participants in this group were able to access work if they enrolled in the methadone treatment and consistently took their medication, but they also received a decrease in base pay if they test positive for opiates or cocaine on the drug screens (employment-based reinforcement). | Behavioral: methadone contingency<br>* Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.<br>Behavioral: Methadone & Abstinence Contingency<br>* Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace and they had to provide opiate and cocaine negative urine samples to maintain the maximum pay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Months in Methadone Treatment | The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period? | 6 months | 
| Percentage of Monthly Urine Sample Negative for Opiates | Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation | 6 months | 
| Percentage of Monthly Urine Samples Negative for Cocaine | Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period? | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of M,W,F Urine Samples Negative for Cocaine | Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period? | 6 months | 
| Percentage of M,W,F Urine Samples Negative for Opiates | Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period? | 6 months |