Overview

This trial is active, not recruiting.

Condition opiate dependence
Treatment employment based reinforcement
Phase phase 2
Sponsor Johns Hopkins University
Collaborator National Institute on Drug Abuse (NIDA)
Start date October 2008
End date October 2013
Trial size 162 participants
Trial identifier NCT01416584, NIDA-23864-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Usual Care Control: Participants in this group will be offered employment in the Therapeutic Workplace without urinalysis testing or the methadone treatment requirement. They will be offered the methadone treatment but are not required to join in order to gain access to the workplace.
employment based reinforcement
Methadone, which can reduce injection heroin use and injection-related HIV risk, will be used. Participants will be offered to enroll in methadone treatment and given access to a Therapeutic Workplace. Participants who are deemed eligible (N=162) will be randomly assigned to one of three groups. All groups will be invited to work in the Therapeutic Workplace and will be prescribed methadone for 6 months.
(Experimental)
Methadone Contingency Group: Participants in this group will only be allowed to work and earn wages as long as they enroll in the methadone treatment and continue to take does of methadone consistently.
employment based reinforcement
Methadone, which can reduce injection heroin use and injection-related HIV risk, will be used. Participants will be offered to enroll in methadone treatment and given access to a Therapeutic Workplace. Participants who are deemed eligible (N=162) will be randomly assigned to one of three groups. All groups will be invited to work in the Therapeutic Workplace and will be prescribed methadone for 6 months.
(Experimental)
Methadone & Abstinence Contingency: Participants will only be able to access work if they enroll in the methadone treatment and consistently take their medication, but also will receive a decrease in base pay if they test positive for opiates or cocaine on the drug screens.
employment based reinforcement
Methadone, which can reduce injection heroin use and injection-related HIV risk, will be used. Participants will be offered to enroll in methadone treatment and given access to a Therapeutic Workplace. Participants who are deemed eligible (N=162) will be randomly assigned to one of three groups. All groups will be invited to work in the Therapeutic Workplace and will be prescribed methadone for 6 months.

Primary Outcomes

Measure
Did each participant enter methadone treatment at any point in the intervention evaluation period?
time frame: At the 6-month follow-up assessment
Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?
time frame: At the 6-month follow-up assessment
Was each participant in methadone treatment at each of the 30-day assessments conducted during the 6-month intervention evaluation period?
time frame: At 30-day assessments
Was the participant's urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation period?
time frame: At 30-day assessments
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: On Monday, Wednesday, and Friday during evaluation period
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: At 30-day assessments
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: At Monday, Wednesday, and Friday throughout the intervention period

Secondary Outcomes

Measure
Did participant inject drugs?
time frame: At 30-day assessments
Did participant share needles or works?
time frame: At 30-day assessments
Did participant inject drugs in a shooting gallery/house or other place where users go to shoot-up?
time frame: At 30-day assessments

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Applicants will be blind to the full details of the eligibility criteria.

Additional Information

Principal investigator Kenneth Silverman, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Johns Hopkins University.