The Therapeutic Workplace Initiation Study - Full Text View

Purpose

The primary purpose of the study is to determine if the central feature of the Therapeutic Workplace, the abstinence reinforcement contingency, is critical to initiate cocaine abstinence in injection drug using methadone patients who use cocaine consistently during methadone treatment. All subjects initially will be invited to attend the Therapeutic Workplace for an initial period, but abstinence will not be required to work during that time. During this initial period, vouchers will be contingent only on workplace attendance and performance on the training programs. Subjects (n=70) who attend the workplace consistently during the first 4 weeks of treatment, but who continue to use cocaine will be randomly assigned to a Work Only or an Abstinence Plus Work group. Subjects in the Work Only group will continue to be able to work independent of their urinalysis results. However, subjects in the Abstinence Plus Work group will be required to provide urine samples that show evidence of recent cocaine abstinence. Subjects in both groups will be invited to stay in the workplace for 6 months. We expect the subjects in the Abstinence and Work group will achieve higher rates of abstinence than the subjects in the Work Only group. This result would show that the abstinence reinforcement contingency (i.e., the requirement to provide cocaine-free urine samples to work and earn vouchers) is important in the initiation of abstinence in the study population.

Condition	Intervention
Cocaine-Related Disorders Opioid-Related Disorders Heroin Dependence Substance Abuse, Intravenous	Behavioral: Abstinence & Work Behavioral: Work Only


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	The Therapeutic Workplace Initiation Study

Further study details as provided by Kenneth Silverman, Johns Hopkins University:

Primary Outcome Measures:

Cocaine Abstinence [ Time Frame: 6 months ]
Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine


Enrollment:	117
Study Start Date:	April 2003
Study Completion Date:	October 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Abstinence & Work Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.	Behavioral: Abstinence & Work Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.
Work Only Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.	Behavioral: Work Only Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Baseline inclusion criteria:

are at least 18 years of age
are enrolled in methadone maintenance treatment in Baltimore
provide a cocaine-positive urine sample at time of initial screening
self-report cocaine use through intravenous route
have visible evidence of intravenous drug use (i.e., track marks).

Baseline exclusion criteria:

report current suicidal ideation
if the individual reports hallucinations
have physical limitations (e.g., broken fingers) that prevent the subject from typing.
Applicants reporting hallucinations are excluded because this is a characteristic of a psychiatric disorder that is likely to result in behaviors that could disrupt the workplace or functioning or limit their ability to provide informed consent.

Main study inclusion criteria:

have attended the workplace regularly during 4-week baseline periods
are still in methadone maintenance treatment at the end of the 4-week baseline period
have provided at least two urine samples that test positive for cocaine during the baseline period
Individuals who are excluded from the main study will be allowed to complete their 8-week training program in the Therapeutic Workplace. They may also be invited to participate in other studies ongoing at the Center for Learning and Health where this research takes place.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249470

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.	Johns Hopkins University

More Information

Publications:

Silverman K, Wong CJ, Needham M, Diemer KN, Knealing T, Crone-Todd D, Fingerhood M, Nuzzo P, Kolodner K. A randomized trial of employment-based reinforcement of cocaine abstinence in injection drug users. J Appl Behav Anal. 2007 Fall;40(3):387-410.


Responsible Party:	Kenneth Silverman, Kenneth Silverman, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00249470 History of Changes
Other Study ID Numbers:	NIDA-12564-1 R01DA012564-01 ( U.S. NIH Grant/Contract )
Study First Received:	November 3, 2005
Results First Received:	September 2, 2016
Last Updated:	October 25, 2016

Keywords provided by Kenneth Silverman, Johns Hopkins University:


HIV HIV risk behaviors Heroin Cocaine Methadone	Opioid Dependence Cocaine Abuse Contingency management alcohol & drug use sexual risk behaviors

Additional relevant MeSH terms:


Disease Substance-Related Disorders Opioid-Related Disorders Cocaine-Related Disorders Heroin Dependence Substance Abuse, Intravenous Pathologic Processes Chemically-Induced Disorders Mental Disorders Cocaine Anesthetics, Local Anesthetics	Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 19, 2017