The Therapeutic Workplace Initiation Study
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ClinicalTrials.gov Identifier: NCT00249470 |
Recruitment Status
:
Completed
First Posted
: November 7, 2005
Results First Posted
: December 16, 2016
Last Update Posted
: December 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine-Related Disorders Opioid-Related Disorders Heroin Dependence Substance Abuse, Intravenous | Behavioral: Abstinence & Work Behavioral: Work Only | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 117 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Therapeutic Workplace Initiation Study |
Study Start Date : | April 2003 |
Actual Primary Completion Date : | May 2004 |
Actual Study Completion Date : | October 2004 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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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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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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- Cocaine Abstinence [ Time Frame: 6 months ]Percentage of Monday, Wednesday, Friday urine samples that are negative for cocaine
- Percent Opiate Negative [ Time Frame: every month for 6 months ](total number of opiate-negative urine samples divided by the total number of urine samples provided)*100
- HIV Risk Behaviors [ Time Frame: every month for 6 months ]Report no injection drug use or crack cocaine use.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249470
United States, Maryland | |
The Center for Learning and Health | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Kenneth Silverman, Ph.D. | Johns Hopkins University |
Publications of Results:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00249470 History of Changes |
Other Study ID Numbers: |
WIRB 2162 R01DA012564 ( U.S. NIH Grant/Contract ) |
First Posted: | November 7, 2005 Key Record Dates |
Results First Posted: | December 16, 2016 |
Last Update Posted: | December 27, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by 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 |