A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment

NCT ID: NCT01416584

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Opiate Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Methadone Contingency Group

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).

Group Type: EXPERIMENTAL

methadone contingency

Intervention Type: BEHAVIORAL

Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.

Methadone & Abstinence Contingency

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).

Group Type: EXPERIMENTAL

methadone contingency

Intervention Type: BEHAVIORAL

Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.

Methadone & Abstinence Contingency

Intervention Type: BEHAVIORAL

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.

Interventions

methadone contingency

Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Silverman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, Johns Hopkins University School of Medicine

Locations

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

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24607365 (View on PubMed)

Other Identifiers

R01DA023864

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00020746

Identifier Type: -

Identifier Source: org_study_id