Employment-based Reinforcement of Naltrexone Ingestion and Abstinence

NCT00149669 | Completed Results

• 2 other identifiers: NA_00039284R01DA019386
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine-Related Disorders; Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous

Keywords

Behavior Therapy; Cocaine; Cocaine (IV); Cocaine Abuse; Cocaine Dependence; Contingency management; HIV risk behaviors; Heroin; Naltrexone; Opioid Dependence; sexual risk behaviors

Outcome Measures

Primary Outcomes (1)

• Percentage of Urine Samples Positive for Naltrexone

  The number of urine samples positive for naltrexone divided by the total number of urine samples times 100.

  6 months

Secondary Outcomes (2)

• Percentage of Urine Samples Negative for Cocaine

  6 months

• Percentage of Urine Samples Negative for Opiates

  6 months

Other Outcomes (4)

• HIV Risk Behaviors

  6 months

• Cost Benefit Analysis

  6 months

• Percentage of Urine/Breath Samples Negative for Other Drugs of Abuse

  6 months

Study Arms (2)

Work Plus Naltrexone Prescription

NO INTERVENTION

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.

Work Plus Naltrexone Contingency

EXPERIMENTAL

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

Interventions

employment-based reinforcement BEHAVIORAL

Work Plus Naltrexone Contingency participants were required to ingest naltrexone to work, and received a brief pay decrease for missing a dose.

Work Plus Naltrexone Contingency

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

• 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.

  PMID: 23205722 RESULT

• 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.

  PMID: 25134047 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Results Point of Contact

• Title: Kenneth Silverman
• Organization: Johns Hopkins University School of Medicine

ksilverm@jhmi.edu

410-550-2694

Study Officials

• Kenneth Silverman, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 14, 2017
• Results First Posted: August 16, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)