Employment-Based Reinforcement to Motivate Naltrexone Ingestion and Drug Abstinence in the Treatment of Drug Addiction. - 1

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was: Not yet recruiting

Sponsor:

Collaborator:

Johns Hopkins University

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00149669

First received: September 6, 2005

Last updated: November 3, 2005

Last verified: November 2005

History of Changes

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 three groups. All 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 and Abstinence Contingency participants will be required to ingest naltrexone to work, and will receive a brief pay decrease for missing a dose of naltrexone or for providing an opiate or cocaine positive urine sample. 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 two groups 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 two groups exposed to the employment-based naltrexone treatment significantly more than the group exposed to usual-care treatment package. Cocaine abstinence will be increased in the group reinforced for cocaine abstinence significantly more than the group not exposed to abstinence reinforcement.

Condition	Intervention
Behavior Therapy Cocaine Cocaine (IV) Cocaine Abuse Cocaine Dependence Contingency Management HIV Risk Behaviors Heroin Heroin Dependence Naltrexone Opioid Dependence Substance Abuse, Intravenous Sexual Risk Behaviors	Behavioral: Contingency management


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Employment-Based Addiction Pharmacotherapy

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

percentage of urine samples negative for naltrexone
percentage of urine samples negative for opiates
percentage of urine samples negative for cocaine

Secondary Outcome Measures:

HIV risk behaviors
cost benefit analysis
percentage of urine/breath samples negative for other drugs of abuse


Estimated Enrollment:	275

Eligibility


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

Criteria

Inclusion Criteria:

CDU patients will be invited to participate in the study if they: a) self-report injection drug use; b) have observable injection track marks; c) provide opiate-positive urine at intake to the CDU; d) provided cocaine-positive urine at intake to the CDU; e) meet DSM IV criteria for Opiate Dependence; f) are unemployed; g) are between the ages of 18 and 65 years old; h) are medically approved to take naltrexone treatment; i) report no interest in methadone treatment; j) live within reasonable commuting distance to the Therapeutic Workplace (e.g, all Baltimore City zipcodes and the following Baltimore County zipcodes will be included: 21221, 21220, 21222, 21236, 21237, 21234, 21204, 21212).

Exclusion Criteria:

Patients will be excluded if they a) have current major axis I disorders (e.g., Bipolar Disorder, Schizophrenia, Psychosis NOS, Schizophreniform Disorder, Schizoaffective Disorder); b) if they are pregnant or breastfeeding; c) if serum aminotransferases results are over three times normal; d) or if the need for opioids to treat an identified medical problem is anticipated; e) if physical limitations would prevent them from working (e.g., has a cast on their hand preventing them from using fingers to type). In addition, the patients with active tuberculosis are not kept on the CDU, so those individuals will not participate in this research. These criteria should maintain sample homogeneity, thereby minimizing the impact of potential confounding variables while insuring patient safety and ability to provide informed consent.

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: NCT00149669

Contacts


Contact: Karly N Diemer, M.A., B.S.	(410)550-6723	kdiemer@jhmi.edu

Locations


United States, Maryland
The Center for Learning and Health	Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Kenneth Silverman, Ph.D. 410-550-2694 ksilverm@jhmi.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators


Principal Investigator:	Kenneth Silverman, Ph.D.	Johns Hopkins University

More Information

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.


ClinicalTrials.gov Identifier:	NCT00149669 History of Changes
Other Study ID Numbers:	NIDA-19386-1 R01-19386-1
Study First Received:	September 6, 2005
Last Updated:	November 3, 2005

Additional relevant MeSH terms:


Cocaine-Related Disorders Substance-Related Disorders Heroin Dependence Substance Abuse, Intravenous	Chemically-Induced Disorders Mental Disorders Opioid-Related Disorders

ClinicalTrials.gov processed this record on June 26, 2017

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