This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

The Therapeutic Workplace Initiation Study

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kenneth Silverman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00249470
First received: November 3, 2005
Last updated: October 25, 2016
Last verified: October 2016
  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: 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.

  Show Detailed Description

  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:
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 ( US NIH Grant/Contract Award Number )
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 June 27, 2017