N/A
N=98
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01416584 ↗Enrolled (actual)
98
Serious AEs
2.0%
Results posted
Sep 2017
Primary outcome: Primary: Percentage of Months in Methadone Treatment — 81; 82; 88 percent of months in methadone treatment — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- methadone contingency (Behavioral); Methadone & Abstinence Contingency (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Months in Methadone Treatment |
81; 82; 88 | 0.60 |
| PRIMARY Percentage of Monthly Urine Sample Negative for Opiates |
54; 61; 75 | 0.02 sig |
| PRIMARY Percentage of Monthly Urine Samples Negative for Cocaine |
32; 55; 57 | 0.02 sig |
| SECONDARY Percentage of M,W,F Urine Samples Negative for Cocaine |
25; 44; 48 | 0.01 sig |
| SECONDARY Percentage of M,W,F Urine Samples Negative for Opiates |
43; 50; 65 | 0.01 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01416584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.