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Employment-Based Depot Naltrexone Clinical Trial II

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ClinicalTrials.gov Identifier: NCT00684775
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : December 26, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

May 23, 2008
May 28, 2008
August 30, 2016
December 26, 2017
January 23, 2018
May 2008
April 30, 2010   (Final data collection date for primary outcome measure)
  • Naltrexone Injections Received [ Time Frame: 24 weeks ]
    The percentage of depot naltrexone doses that participants received
  • Time to the First Missed Dose [ Time Frame: 24 weeks ]
    The time to the first missed dose of depot naltrexone
  • The number of depot naltrexone doses that participants received [ Time Frame: When all participants have completed the study ]
  • The time to the first missed dose of depot naltrexone [ Time Frame: When all participants have completed the study ]
Complete list of historical versions of study NCT00684775 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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.
  • HIV Risk Behaviors [ Time Frame: 24 weeks ]
    behaviors that place participants at risk for acquiring or transmitting HIV infection
  • 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
  • Percentage of urine samples collected at the 30-day assessments that are positive for opiates [ Time Frame: When all participants have completed the study ]
  • Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for cocaine [ Time Frame: When all participants have completed the study ]
  • Percentage of urine samples collected at the 30-day assessments that are positive for cocaine [ Time Frame: When all participants have completed the study ]
  • HIV Risk Behaviors [ Time Frame: When all participants have completed the study ]
  • Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for opiates [ Time Frame: When all participants have completed the study ]
Not Provided
Not Provided
 
Employment-Based Depot Naltrexone Clinical Trial II
Employment-Based Depot Naltrexone Clinical Trial II
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Opiate Dependence
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
  • 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.
    Intervention: Combination Product: Work Plus Naltrexone Contingency
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. Drug Alcohol Depend. 2012 Jan 1;120(1-3):48-54. doi: 10.1016/j.drugalcdep.2011.06.023. Epub 2011 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
40
April 30, 2010
April 30, 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00684775
NIDA-19497-2
R01DA019497-02 ( U.S. NIH Grant/Contract )
NA_00000928 ( Other Identifier: Johns Hopkins Medicine IRB )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kenneth Silverman, Ph.D. Professor, Johns Hopkins University School of Medicine
Johns Hopkins University
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP