Employment-Based Depot Naltrexone Clinical Trial II

Opiate Dependence Clinical Trial

Official title:

Employment-Based Depot Naltrexone Clinical Trial II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684775
• Other study ID #: NIDA-19497-2
• Secondary ID: R01DA019497-02NA
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: December 27, 2017
• Start date: May 2008
• Est. completion date: April 30, 2010

Study information

• Verified date: December 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 to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) 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. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections 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: 38
• Est. completion date: April 30, 2010
• Est. primary completion date: April 30, 2010
• 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 (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.

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Combination Product:
• Work Plus Naltrexone Contingency
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.

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)

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. Dr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Naltrexone Injections Received	The percentage of depot naltrexone doses that participants received	24 weeks
Primary	Time to the First Missed Dose	The time to the first missed dose of depot naltrexone	24 weeks
Secondary	Percentage of 30-day Urine Samples Negative for Opiates	Percentage of urine samples collected at the 30-day assessments that are negative for opiates	Collected every 30 days for 150 days
Secondary	Percentage of M-W-F Samples Negative for Cocaine	Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine	Collected every Monday, Wednesday and Friday for 24 weeks
Secondary	Average Percentage of 30-day Urine Samples Negative for Cocaine	The percentage of urine samples collected at 30-day assessments that are negative for cocaine.	Collected every 30 days for 150 days
Secondary	HIV Risk Behaviors	behaviors that place participants at risk for acquiring or transmitting HIV infection	24 weeks
Secondary	Percentage of M,W,F Urine Samples Negative for Opiates	Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates	Collected every Monday, Wednesday and Friday for 24 weeks