Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

This study has been completed.
Sponsor:
Collaborators:
Alkermes, Inc.
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Joshua D. Lee, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01180647
First received: August 10, 2010
Last updated: March 8, 2016
Last verified: March 2016
Results First Received: April 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Opiate Dependence
Interventions: Drug: Extended-Release Naltrexone
Behavioral: Motivational Enhancement Counseling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment of participants took place at NYC jail medical clinics (Rikers Island; EMTC, RMSC) with follow-up visits taking place at Bellevue Hospital. The last participant completed in June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 48 consented participants enrolled into study between January 2010-May 2013, 34 were randomized into one of two trial arms, with n=17 to Extended-Release Naltrexone arm and n=17 to the Motivational Enhancement Counseling Only arm (treatment-as-usual).

Reporting Groups
  Description
Extended-release Naltrexone (XR-NTX)

A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.

Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).

Motivational Enhancement Counseling Only

The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.


Participant Flow:   Overall Study
    Extended-release Naltrexone (XR-NTX)     Motivational Enhancement Counseling Only  
STARTED     17     17  
COMPLETED     12     11  
NOT COMPLETED     5     6  
Lost to Follow-up                 5                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis determined based on: (1) successful randomization into one of two treatment arms (ETAU;XR-NTX) and (2) actual release from jail back to the community. One participant who successfully randomized to XR-NTX was never released from jail custody and was instead sent to prison and therefore excluded from final analysis.

Reporting Groups
  Description
Extended-release Naltrexone (XR-NTX)

A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.

Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).

Motivational Enhancement Counseling Only

The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Total Total of all reporting groups

Baseline Measures
    Extended-release Naltrexone (XR-NTX)     Motivational Enhancement Counseling Only     Total  
Number of Participants  
[units: participants]
  16     17     33  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     17     33  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Full Range)
  40  
  (26 to 52)  
  47  
  (39 to 58)  
  44  
  (26 to 58)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     16     17     33  
Region of Enrollment  
[units: participants]
     
United States     16     17     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post-Release Opioid Relapse   [ Time Frame: Four weeks post-release ]

2.  Secondary:   Participation in Community Drug Treatment Post-release   [ Time Frame: Four weeks post-release ]

3.  Secondary:   Any Opioid Use Post-release   [ Time Frame: Four weeks post-release ]

4.  Secondary:   Injection Drug Use Post-release   [ Time Frame: Four weeks post-release ]

5.  Secondary:   Accidental Drug Overdose   [ Time Frame: Four weeks post-release ]

6.  Secondary:   Adverse Events and Serious Adverse Events   [ Time Frame: Eight weeks post-release ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of this pilot study are: small sample size, no females enrolled in study, and no placebo control group.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joshua D. Lee
Organization: NYU School of Medicine
phone: 212-263-4242
e-mail: joshua.lee@nyumc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joshua D. Lee, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01180647     History of Changes
Other Study ID Numbers: NYU IRB Number: 09-0372
Study First Received: August 10, 2010
Results First Received: April 13, 2015
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration