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Employment-Based Depot Naltrexone Clinical Trial II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00684775
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : December 25, 2017
Last Update Posted : December 25, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Combination Product: Work Plus Naltrexone Contingency Phase 2

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Employment-Based Depot Naltrexone Clinical Trial II
Actual Study Start Date : May 2008
Primary Completion Date : April 30, 2010
Study Completion Date : April 30, 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Work Plus Naltrexone Prescription
Participants could work and earn vouchers but did not to take Vivitrol Injections to work and earn vouchers.
Experimental: Work Plus Naltrexone Contingency
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
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.
Other Name: contingency management


Outcome Measures

Primary Outcome Measures :
  1. Naltrexone Injections Received [ Time Frame: 24 weeks ]
    The percentage of depot naltrexone doses that participants received

  2. Time to the First Missed Dose [ Time Frame: 24 weeks ]
    The time to the first missed dose of depot naltrexone


Secondary Outcome Measures :
  1. Percentage of 30-day Urine Samples Negative for Opiates [ Time Frame: Collected every 30 days for 150 days ]
    Percentage of urine samples collected at the 30-day assessments that are negative for opiates

  2. Percentage of M-W-F Samples Negative for Cocaine [ Time Frame: Collected every Monday, Wednesday and Friday for 24 weeks ]
    Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine

  3. Average Percentage of 30-day Urine Samples Negative for Cocaine [ Time Frame: Collected every 30 days for 150 days ]
    The percentage of urine samples collected at 30-day assessments that are negative for cocaine.

  4. HIV Risk Behaviors [ Time Frame: 24 weeks ]
    behaviors that place participants at risk for acquiring or transmitting HIV infection

  5. Percentage of M,W,F Urine Samples Negative for Opiates [ Time Frame: Collected every Monday, Wednesday and Friday for 24 weeks ]
    Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684775


Locations
United States, Maryland
The Center for Learning and Health
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kenneth Silverman, Ph.D. Professor, Johns Hopkins University School of Medicine
More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00684775     History of Changes
Other Study ID Numbers: NIDA-19497-2
R01DA019497-02 ( U.S. NIH Grant/Contract )
NA_00000928 ( Other Identifier: Johns Hopkins Medicine IRB )
First Posted: May 28, 2008    Key Record Dates
Results First Posted: December 25, 2017
Last Update Posted: December 25, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents