A Bridge to Treatment: The Therapeutic Workplace and Methadone Treatment - Full Text View

Purpose

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.

Condition	Intervention	Phase
Opiate Dependence	Behavioral: employment based reinforcement	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Did each participant enter methadone treatment at any point in the intervention evaluation period? [ Time Frame: At the 6-month follow-up assessment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Did participant inject drugs? [ Time Frame: At 30-day assessments ] [ Designated as safety issue: No ]
Did participant share needles or works? [ Time Frame: At 30-day assessments ] [ Designated as safety issue: No ]
Did participant inject drugs in a shooting gallery/house or other place where users go to shoot-up? [ Time Frame: At 30-day assessments ] [ Designated as safety issue: No ]

Estimated Enrollment:	162
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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.	Behavioral: 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: 2 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.	Behavioral: 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: 3 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.	Behavioral: 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.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416584

Locations

United States, Maryland
The Center for Learning and Health
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kenneth Silverman, Ph.D.

Professor, Johns Hopkins University School of Medicine

More Information

No publications provided

Responsible Party:	Kenneth Silverman, Professor of Psychiatry and Behavioral Sciences, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01416584 History of Changes
Other Study ID Numbers:	NIDA-23864-1
Study First Received:	August 12, 2011
Last Updated:	March 25, 2013
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013