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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenneth Silverman, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01556425
First received: March 5, 2012
Last updated: March 5, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
Drug: Vivitrol
Behavioral: Employment based opiate abstinence reinforcement
Other: Usual Care Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Opiate use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)?

  • Injection of heroin [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Did the participant report injecting heroin in the past week at each of the 24 weekly assessments scheduled after random assignment (Y/N)?


Secondary Outcome Measures:
  • Cocaine Use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Was the participant's urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)?

  • Injection of cocaine [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Did the participant report injecting cocaine in the past week at each of the 24 weekly assessments scheduled after random assignment (Y/N)?

  • Risky injection behavior [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Did the participant report any risky injection behavior (including sharing needles/syringes without disinfecting, sharing cookers/cottons/rinse water, or sharing drug solution) in the past week at each of the 24 weekly assessments after random assignment (Y/N)?


Estimated Enrollment: 124
Study Start Date: May 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vivitrol Only
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
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.
Experimental: VIVITROL & Opiate Abstinence Reinforcement
Like the VIVITROL Only group, this group will be offered VIVITROL injections and will be required to take the injections to attend the workplace and to maintain their maximum pay. However, to reduce or eliminate the opiate use that we expect will persist in participants in the VIVITROL Only group, this group will also receive an employment-based opiate reinforcement contingency. This contingency will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday 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
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.
Behavioral: Employment based opiate abstinence reinforcement
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.
Experimental: Opiate Abstinence Reinforcement Only
This group would receive the same employment-based opiate reinforcement contingency as participants in the VIVITROL & Opiate Abstinence Reinforcement group, but this group will not receive VIVITROL.
Behavioral: Employment based opiate abstinence reinforcement
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.
Usual Care Control
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
Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.

Detailed Description:

Injection heroin use is a chronic problem that fuels the transmission of HIV/AIDS through risky injection behaviors. Methadone and buprenorphine can reduce heroin use and risky injection behavior; however, they have abuse potential, produce physical dependence, can produce lethal overdose, are highly regulated, and some patients simply do not want agonist treatment. Opiate detoxifications can serve as an alternative to agonist treatment, but many injection drug users relapse to heroin use and resume risky injection behaviors after detoxification. Vivitrol®, an extended release formulation of naltrexone, was recently approved by the FDA for the treatment of opioid dependence, but its clinical utility is uncertain given the reluctance of many opioid-dependent adults to maintain its long-term use, and the fact that some patients continue to use opiates while under naltrexone blockade. The investigators research in the first period of this grant showed that employment-based reinforcement can be highly effective in promoting long-term adherence to Vivitrol®. Employment-based reinforcement may be ideally suited to address the limitations of extended release naltrexone by capitalizing on its potential to simultaneously reinforce naltrexone adherence and opiate abstinence. This grant will evaluate the effectiveness of employment-based reinforcement to simultaneously promote high rates of Vivitrol® adherence and increase opiate abstinence. After an opioid detoxification and induction onto oral naltrexone, participants will be invited to attend the Therapeutic Workplace for 24 weeks (where they can work and earn wages) and will be randomly assigned to one of four groups that will differ in whether they receive Vivitrol®, employment-based opiate abstinence reinforcement, both or neither. Participants in Vivitrol® conditions will be required to take scheduled injections to work and earn wages. Participants exposed to opiate abstinence reinforcement will receive a temporary decrease in their workplace pay if they fail to provide an opiate-free urine sample. The study will assess the effects of the interventions on weekly opiate urinalysis results, and on measures of injection drug use and cocaine use. If this study shows that the combined use of Vivitrol® and employment-based reinforcement of adherence and opiate abstinence is effective in maintaining long-term opiate abstinence, this model of employment-based addiction pharmacotherapy could be integrated into community workplaces to disseminate the effective use of Vivitrol®; it could be used to enhance the utility of other new antagonist-like addiction medications; and it could provide an effective means of reducing injection drug use in individuals who persist in injecting heroin and exposing themselves and others to the risk of acquiring or transmitting HIV infection due to their continued injection drug use and risky injection behaviors.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Applicants will be blind to the full details of the eligibility criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556425

Contacts
Contact: Jeanne Harrison, M.S. 410-550-6723 jeanne@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Center for Learning and Health Recruiting
Baltimore, Maryland, United States, 21224
Contact: J H    410-550-7713      
Principal Investigator: Kenneth Silverman, Ph.D.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Kenneth Silverman, Professor of Psychiatry and Behavioral Sciences, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01556425     History of Changes
Other Study ID Numbers: NA_00052254, 2R01DA019497-06
Study First Received: March 5, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014