The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

NCT01556425 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: NA_000522542R01DA019497-06
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In this 5-year study, the investigators propose to evaluate the separate and combined effects of the FDA-approved formulation of extended release naltrexone (Vivitrol®) and employment-based reinforcement of opiate abstinence in promoting opiate abstinence and reducing risky injection behavior in recently detoxified, opioid-dependent, injection drug users.

Conditions

Opioid Dependence

Keywords

opioid use disorder; treatment; heroin; extended-release naltrexone; incentives; cotningency management; employment-based reinforcement; therapeutic workplace

Outcome Measures

Primary Outcomes (1)

• Percent of Weekly Urine Samples Negative for Opiates

  Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates.

  24 weeks

Secondary Outcomes (1)

• Percent of Weekly Urine Samples Negative for Cocaine

  24 weeks

Study Arms (4)

Vivitrol Only

EXPERIMENTAL

The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.

Drug: Vivitrol

VIVITROL&Opiate Abstinence Reinforcement

EXPERIMENTAL

This group will be offered VIVITROL and will be required to take it to attend the workplace and to maintain maximum pay. This group will also receive employment-based opiate abstinence reinforcement. This contingency will require participants to provide opiate-negative urine samples on M,W, and F to maintain their maximum pay. If a participant in this group provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.

Drug: Vivitrol; Behavioral: Employment-based opiate abstinence reinforcement

Opiate Abstinence Reinforcement Only

EXPERIMENTAL

This group would receive employment-based opiate abstinence reinforcement, but this group will not receive VIVITROL.

Behavioral: Employment-based opiate abstinence reinforcement

Usual Care Control

OTHER

This group will receive neither abstinence reinforcement nor VIVITROL injections, but they will be invited to attend the workplace and outpatient drug abuse counseling.

Other: Usual Care Control

Interventions

Vivitrol DRUG

Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.

VIVITROL&Opiate Abstinence Reinforcement; Vivitrol Only

Employment-based opiate abstinence reinforcement BEHAVIORAL

This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.

Opiate Abstinence Reinforcement Only; VIVITROL&Opiate Abstinence Reinforcement

Usual Care Control OTHER

Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.

Usual Care Control

Eligibility Criteria

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

You may qualify if:

• meet the DSM-IV criteria for opioid dependence,
• report using heroin at least 21 of the last 30 days while living in the community,
• are unemployed,
• are 18-65 years old,
• are medically approved for naltrexone,
• live in or near Baltimore, MD.

You may not qualify if:

• have current DSM-IV major Axis I disorders
• have current suicidal or homicidal ideation
• express interest in methadone treatment
• are required to use opioids for medical purposes
• earned over $200 in taxable income over the previous 30 days while living in the community
• have physical limitations that prevent them from using a keyboard
• are pregnant or breastfeeding
• have serum aminotransferase levels over three times normal
• have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;
• are participating in any other clinical study.

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Bayview Center for Learning and Health

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

  PMID: 40342086 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Small sample size

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

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 16, 2012
• Study Start: May 1, 2012
• Primary Completion: December 12, 2016
• Study Completion: August 6, 2017
• Last Updated: March 12, 2018
• Results First Posted: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)