Employment-Based Depot Naltrexone Clinical Trial

NCT00684788 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: NA_00000928-1R01DA019497
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

Conditions

Opiate Dependence

Keywords

opiate dependence; naltrexone; reinforcement; behavior therapy; cocaine dependence; risk reduction behavior

Outcome Measures

Primary Outcomes (1)

• Percentage of Depot Naltrexone Doses Received

  The number of depot naltrexone injections received/divided by the total number of injections possible for each participant.

  18 Weeks

Secondary Outcomes (6)

• The Time to the First Missed Dose of Depot Naltrexone

  18 weeks

• Percentage of 30-day Assessments Urine Samples Negative for Opiates

  4 months

• Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates

  18 weeks

• Percentage of 30-day Assessments Urine Samples Negative for Cocaine

  4 months

• Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine

  18 weeks

Study Arms (2)

No Intervention

NO INTERVENTION

Participants were offered depot naltrexone injections and were not required to take scheduled injections to work.

Employment-based reinforcement

EXPERIMENTAL

Participants were offered depot naltrexone injections and were required to take scheduled injections to work.

Combination Product: employment-based reinforcement

Interventions

employment-based reinforcement COMBINATION_PRODUCT

Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Employment-based reinforcement

Eligibility Criteria

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

Individuals were eligible if they: * met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence, * reported using heroin on at least 21 of the last 30 days while in community, * were unemployed, * were aged 18-65 years, * were medically approved for naltrexone * lived in or near Baltimore, MD. Individuals were excluded if they * had current DSM-IV major Axis I disorders, * had current suicidal or homicidal ideation, * expressed interest in methadone treatment, * were required to use opioids for medical purposes, * earned more than $200 in taxable income over the previous 30 days, * had physical limitations that would prevent them from using a keyboard, * were pregnant or breastfeeding, * had serum aminotransferase levels more than three times over normal.

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)

• Everly JJ, DeFulio A, Koffarnus MN, Leoutsakos JM, Donlin WD, Aklin WM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to depot naltrexone in unemployed opioid-dependent adults: a randomized controlled trial. Addiction. 2011 Jul;106(7):1309-18. doi: 10.1111/j.1360-0443.2011.03400.x. Epub 2011 May 3.

  PMID: 21320227 RESULT

• DeFulio A, Everly JJ, Leoutsakos JM, Umbricht A, Fingerhood M, Bigelow GE, Silverman K. Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial. Drug Alcohol Depend. 2012 Jan 1;120(1-3):48-54. doi: 10.1016/j.drugalcdep.2011.06.023. Epub 2011 Jul 22.

  PMID: 21782353 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Cocaine-Related Disorders; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Kenneth Silverman
• Organization: Hopkins School of Medicine: Department of Psychiatry

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: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: May 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 3, 2009
• Last Updated: December 26, 2017
• Results First Posted: December 26, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)