Employment-based Reinforcement of Naltrexone Ingestion and Abstinence
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ClinicalTrials.gov Identifier: NCT00149669 |
Recruitment Status
:
Completed
First Posted
: September 8, 2005
Results First Posted
: August 16, 2017
Last Update Posted
: September 14, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cocaine-Related Disorders Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous | Behavioral: employment-based reinforcement | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Employment-Based Addiction Pharmacotherapy |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |
Arm | Intervention/treatment |
---|---|
No Intervention: Work Plus Naltrexone Prescription
Participants were prescribed naltrexone, but were not be required to ingest it to work. Participants could work and earn money, independent of whether or not they continued to take naltrexone.
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Experimental: Work Plus Naltrexone Contingency
Participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose (employment-based reinforcement of naltrexone ingestion).
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Behavioral: employment-based reinforcement
Work Plus Naltrexone Contingency participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose.
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- Percentage of Urine Samples Positive for Naltrexone [ Time Frame: 6 months ]The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.
- Percentage of Urine Samples Negative for Cocaine [ Time Frame: 6 months ]the number of urine samples that were negative for cocaine divided by the total number of urine samples) x 100
- Percentage of Urine Samples Negative for Opiates [ Time Frame: 6 months ]The number of urine samples negative for opiates divided by the total number of urine samples times 100.
- HIV Risk Behaviors [ Time Frame: 6 months ]Behaviors that place participants at risk for acquiring or transmitting HIV
- Cost Benefit Analysis [ Time Frame: 6 months ]The costs and economic benefits of the intervention
- Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse [ Time Frame: 6 months ]The percentage of urine and breath samples that are negative for other drugs of abuse
- Cocaine Positive Urine Samples [ Time Frame: 6 months ]The number of urine samples that were positive for cocaine

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Volunteers were eligible to participate if they
- were between the ages of 18 and 65 years,
- were unemployed (i.e., reporting no work in the past 30 days and earning $200 in taxable income per month),
- self-reported injection drug use and had visible track marks (assessed via visual inspection),
- provided a urine sample that tested positive for both opiates and cocaine upon entry into detoxification,
- met DSM-IV-TR criteria for opiate dependence,
- were medically approved to be maintained on naltrexone by the study physician,
- and lived within reasonable commuting distance to the research unit (i.e., in Baltimore City and the immediate surrounding area).
Volunteers were excluded if they
- had active hallucinations, delusions, or a thought disorder;
- were judged to be of imminent threat to harm self or others;
- were currently incarcerated, in a halfway house, or under constant monitoring;
- were pregnant or breastfeeding;
- had serum aminotransferase levels over 3 times normal;
- required opiates for other medical problems (and thus could not be maintained on naltrexone, which would block the effects on any opiate);
- reported an interest in methadone treatment;
- had active tuberculosis;
- or had physical limitations that would prevent typing

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): NCT00149669
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00149669 History of Changes |
Other Study ID Numbers: |
NA_00039284 R01DA019386 ( U.S. NIH Grant/Contract ) NA_00039284 ( Other Identifier: Johns Hopkins Medicine IRB ) |
First Posted: | September 8, 2005 Key Record Dates |
Results First Posted: | August 16, 2017 |
Last Update Posted: | September 14, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Johns Hopkins University:
Behavior Therapy Cocaine Cocaine (IV) Cocaine Abuse Cocaine Dependence Contingency management |
HIV risk behaviors Heroin Naltrexone Opioid Dependence 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 Naltrexone Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |