A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Opiate Dependence Clinical Trial

Official title:

A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416584
• Other study ID #: NA_00020746
• Secondary ID: R01DA023864
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: December 1, 2017
• Start date: October 2008
• Est. completion date: April 2014

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• methadone contingency
Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
• Methadone & Abstinence Contingency
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.

Locations

Country	Name	City	State
United States	Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Did Participant Share Needles or Works?	Percent of months that participants reported sharing needles or works.	6 months
Other	Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?	The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.	6 months
Other	Did Participant Inject Drugs?	Percent of months that participants reported injecting drugs.	6 months
Other	In Methadone Treatment at End of Treatment	Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?	6 months
Other	Entered Methadone Treatment	Did the participant enter methadone treatment at any point in the 6-month treatment period?	6 months
Primary	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
Primary	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
Primary	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	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
Secondary	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