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 because the information has not been verified recently.
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Employment-Based Addiction Pharmacotherapy

Resource links provided by NLM:


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
Genders Eligible for Study:   Both
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
Johns Hopkins University
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
  More Information

No publications provided

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
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Heroin Dependence
Substance Abuse, Intravenous
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014