Employment-Based Depot Naltrexone Clinical Trial

Opiate Dependence Clinical Trial

Official title:

Employment-Based Depot Naltrexone Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684788
• Other study ID #: NA_00000928-1
• Secondary ID: R01DA019497
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: November 29, 2017
• Start date: May 2006
• Est. completion date: May 3, 2009

Study information

• Verified date: November 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction will be 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. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 3, 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Combination Product:
• employment-based reinforcement
Participants in the "Work Plus Naltrexone Contingency" condition were required to take scheduled doses of depot naltrexone to work and earn wages.

Locations

Country	Name	City	State
United States	The Center for Learning and Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Time to the First Missed Dose of Depot Naltrexone	The number of weeks until the first missed dose of depot naltrexone	18 weeks
Secondary	Percentage of 30-day Assessments Urine Samples Negative for Opiates	(The number of urine samples that were negative for opiates/total number of urine samples)x 100	4 months
Secondary	Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates	Total number of opiate-negative urine samples divided by the total number of possible urine samples X 100	18 weeks
Secondary	Percentage of 30-day Assessments Urine Samples Negative for Cocaine	(The number of urine samples that were negative for cocaine/total number of urine samples)x 100	4 months
Secondary	Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine	Total number of cocaine-negative urine samples divided by the total number of possible urine samples X 100	18 weeks
Secondary	HIV Risk Behaviors	Went to a crack house	4 months