Clinical trial NCT01416584: 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
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Dependence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-08-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Months in Methadone Treatment
timeFrame: 6 months
measure: Percentage of Monthly Urine Sample Negative for Opiates
timeFrame: 6 months
measure: Percentage of Monthly Urine Samples Negative for Cocaine
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of M,W,F Urine Samples Negative for Cocaine
timeFrame: 6 months
measure: Percentage of M,W,F Urine Samples Negative for Opiates
timeFrame: 6 months
Other outcomes:
measure: Did Participant Share Needles or Works?
timeFrame: 6 months
measure: Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?
timeFrame: 6 months
measure: Did Participant Inject Drugs?
timeFrame: 6 months
measure: In Methadone Treatment at End of Treatment
timeFrame: 6 months
measure: Entered Methadone Treatment
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142
state: Maryland
Study officials:
affiliation: Professor, Johns Hopkins University School of Medicine
name: Kenneth Silverman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.