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A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
methadone contingency
Methadone & Abstinence Contingency
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence

Eligibility Criteria

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

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

Sites / Locations

  • Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual Care Control

Methadone Contingency Group

Methadone & Abstinence Contingency

Arm Description

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.

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).

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).

Outcomes

Primary Outcome Measures

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?
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
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?

Secondary Outcome Measures

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?
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?

Full Information

First Posted
August 12, 2011
Last Updated
December 1, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01416584
Brief Title
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
Official Title
A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Usual Care Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Methadone Contingency Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Methadone & Abstinence Contingency
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
methadone contingency
Intervention Description
Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
Intervention Type
Behavioral
Intervention Name(s)
Methadone & Abstinence Contingency
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Months in Methadone Treatment
Description
The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?
Time Frame
6 months
Title
Percentage of Monthly Urine Sample Negative for Opiates
Description
Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation
Time Frame
6 months
Title
Percentage of Monthly Urine Samples Negative for Cocaine
Description
Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of M,W,F Urine Samples Negative for Cocaine
Description
Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?
Time Frame
6 months
Title
Percentage of M,W,F Urine Samples Negative for Opiates
Description
Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Did Participant Share Needles or Works?
Description
Percent of months that participants reported sharing needles or works.
Time Frame
6 months
Title
Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?
Description
The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.
Time Frame
6 months
Title
Did Participant Inject Drugs?
Description
Percent of months that participants reported injecting drugs.
Time Frame
6 months
Title
In Methadone Treatment at End of Treatment
Description
Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?
Time Frame
6 months
Title
Entered Methadone Treatment
Description
Did the participant enter methadone treatment at any point in the 6-month treatment period?
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, Ph.D.
Organizational Affiliation
Professor, Johns Hopkins University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24607365
Citation
Holtyn AF, Koffarnus MN, DeFulio A, Sigurdsson SO, Strain EC, Schwartz RP, Leoutsakos JM, Silverman K. The therapeutic workplace to promote treatment engagement and drug abstinence in out-of-treatment injection drug users: a randomized controlled trial. Prev Med. 2014 Nov;68:62-70. doi: 10.1016/j.ypmed.2014.02.021. Epub 2014 Mar 4.
Results Reference
derived

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A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

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