Employment-Based Depot Naltrexone Clinical Trial II

NCT00684775 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: NIDA-19497-2R01DA019497-02NA_00000928
• Study Type: interventional
• Target: 38
• 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

Outcome Measures

Primary Outcomes (2)

• Naltrexone Injections Received

  The percentage of depot naltrexone doses that participants received

  24 weeks

• Time to the First Missed Dose

  The time to the first missed dose of depot naltrexone

  24 weeks

Secondary Outcomes (5)

• Percentage of 30-day Urine Samples Negative for Opiates

  Collected every 30 days for 150 days

• Percentage of M-W-F Samples Negative for Cocaine

  Collected every Monday, Wednesday and Friday for 24 weeks

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

  Collected every 30 days for 150 days

• HIV Risk Behaviors

  24 weeks

• Percentage of M,W,F Urine Samples Negative for Opiates

  Collected every Monday, Wednesday and Friday for 24 weeks

Study Arms (2)

Work Plus Naltrexone Prescription

NO INTERVENTION

Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.

Work Plus Naltrexone Contingency

EXPERIMENTAL

Participants could work and earn vouchers and had to take Vivitrol Injections to work and earn vouchers: employment-based reinforcement.

Combination Product: Work Plus Naltrexone Contingency

Interventions

Work Plus Naltrexone Contingency COMBINATION_PRODUCT

Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.

Also known as: contingency management

Work Plus Naltrexone Contingency

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 (DSM)-IV criteria for opioid dependence, * reported using heroin at least 21 of the last 30 days while living in the community, * were unemployed, * were 18-65 years old, * were medically approved for naltrexone, * lived in or near Baltimore, MD. Individuals were excluded if they: * were pregnant or breastfeeding, * had serum aminotransferase levels over three times normal, * had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation, * expressed interest in methadone treatment, * were required to use opioids for medical purposes, * earned over $200 in taxable income over the previous 30 days, * had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.

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 (1)

• 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 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ksilverm@jhmi.edu

410-550-2694

Study Officials

• Kenneth Silverman, Ph.D.

  Professor, Johns Hopkins University School of Medicine

  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, 2008
• Primary Completion: April 30, 2010
• Study Completion: April 30, 2010
• Last Updated: January 23, 2018
• Results First Posted: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)