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Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01077310
First received: February 19, 2010
Last updated: October 4, 2016
Last verified: October 2016
Results First Received: August 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
Problem Drinking
Hazardous Drinking
Human Immunodeficiency Virus
AIDS
Interventions: Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)
Drug: Placebo

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Extended-release Naltrexone

Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Placebo

Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.

Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.


Participant Flow:   Overall Study
    Extended-release Naltrexone   Placebo
STARTED   67   33 
COMPLETED   67   33 
NOT COMPLETED   0   0 



  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.
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Reporting Groups
  Description
Extended-release Naltrexone

Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.

Placebo

Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.

Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.

Total Total of all reporting groups

Baseline Measures
   Extended-release Naltrexone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   33   100 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   67   33   100 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.9  (8.1)   45.2  (8.9)   45.0  (8.4) 
Gender 
[Units: Participants]
     
Female   16   5   21 
Male   51   28   79 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic   11   8   19 
Black (non Hispanic)   46   19   65 
White (non Hispanic)   10   6   16 
Region of Enrollment 
[Units: Participants]
     
United States   67   33   100 
Alcohol use severity by AUDIT 
[Units: Participants]
     
Abstinent or Low Risk Drinking   2   0   2 
Hazardous Drinking   5   2   7 
Harmful Drinking   0   4   4 
Possible Dependence   60   27   87 


  Outcome Measures
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1.  Primary:   Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL   [ Time Frame: Baseline to month 6 post release ]

2.  Secondary:   Alcohol Treatment Outcome: Time to Alcohol Relapse   [ Time Frame: Post release ]

3.  Secondary:   Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day   [ Time Frame: 12 weeks prior to release from prison (baseline) to 6 months post release ]

4.  Secondary:   Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days   [ Time Frame: change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release ]

5.  Other Pre-specified:   Mean Change in CD4 Cell Count (Cells/mL)   [ Time Frame: Baseline and every 3 months for 1 year ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No


  Serious Adverse Events


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  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
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  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: Principle Investigator
Organization: Yale School of Medicine
phone: 203-737-2883
e-mail: sandra.springer@yale.edu


Publications of Results:
Other Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01077310     History of Changes
Other Study ID Numbers: 0908005572
1R01AA018944 ( US NIH Grant/Contract Award Number )
Study First Received: February 19, 2010
Results First Received: August 4, 2016
Last Updated: October 4, 2016
Health Authority: United States: Institutional Review Board