Employment-based Reinforcement of Naltrexone Ingestion and Abstinence

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00149669

First Posted: September 8, 2005

Last Update Posted: September 14, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Johns Hopkins University

Purpose

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent injection drug users. Participants will be offered an opioid detoxification and naltrexone induction. Participants who complete the naltrexone induction will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to work and earn salary. Work Plus Naltrexone Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work Plus Naltrexone Prescription participants will be prescribed naltrexone, but will not be required to ingest it to work. This study will provide a rigorous evaluation of a novel employment-based intervention, the Therapeutic Workplace, to promote naltrexone ingestion and drug abstinence in a population of injection drug users who are at considerable risk of spreading or contracting HIV infection. Hypotheses being tested in this study are: Naltrexone ingestion will be maintained in the group exposed to the employment-based naltrexone treatment significantly more than the group exposed to usual-care treatment package. Opiate abstinence will be maintained in the group exposed to the employment-based naltrexone treatment significantly more than the group exposed to usual-care treatment package.

Condition	Intervention
Cocaine-Related Disorders Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous	Behavioral: employment-based reinforcement


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Employment-Based Addiction Pharmacotherapy

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Other Outcome Measures:

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


Enrollment:	67
Study Start Date:	December 2005
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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).	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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Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

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:

Dunn KE, Defulio A, Everly JJ, Donlin WD, Aklin WM, Nuzzo PA, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to oral naltrexone treatment in unemployed injection drug users. Exp Clin Psychopharmacol. 2013 Feb;21(1):74-83. doi: 10.1037/a0030743. Epub 2012 Dec 3.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dunn K, DeFulio A, Everly JJ, Donlin WD, Aklin WM, Nuzzo PA, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to oral naltrexone in unemployed injection drug users: 12-month outcomes. Psychol Addict Behav. 2015 Jun;29(2):270-6. doi: 10.1037/adb0000010. Epub 2014 Aug 18.


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 Submitted:	September 6, 2005
First Posted:	September 8, 2005
Results First Submitted:	September 2, 2016
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

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