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Trial record 35 of 39 for:    " February 17, 2010":" March 19, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Alcohol Pharmacotherapy for HIV+ Prisoners (INSPIRE)

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ClinicalTrials.gov Identifier: NCT01077310
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : November 25, 2016
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 100

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Extended-release Naltrexone Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 67 33
Completed 67 33
Not Completed 0 0
Arm/Group Title Extended-release Naltrexone Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 67 33 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 33 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
67
 100.0%
33
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 33 participants 100 participants
44.9  (8.1) 45.2  (8.9) 45.0  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 33 participants 100 participants
Female
16
  23.9%
5
  15.2%
21
  21.0%
Male
51
  76.1%
28
  84.8%
79
  79.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 33 participants 100 participants
Hispanic 11 8 19
Black (non Hispanic) 46 19 65
White (non Hispanic) 10 6 16
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants 33 participants 100 participants
67 33 100
Alcohol use severity by AUDIT  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 33 participants 100 participants
Abstinent or Low Risk Drinking 2 0 2
Hazardous Drinking 5 2 7
Harmful Drinking 0 4 4
Possible Dependence 60 27 87
1.Primary Outcome
Title Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL
Hide Description Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.
Time Frame Baseline to month 6 post release
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.
Arm/Group Title Intramuscular Naltrexone Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 67 33
Measure Type: Number
Unit of Measure: percent of participants
54 42
2.Secondary Outcome
Title Alcohol Treatment Outcome: Time to Alcohol Relapse
Hide Description Self reported time to first heavy drinking day after release from incarceration, up to 6 months
Time Frame Post release
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Naltrexone Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 67 33
Mean (Standard Deviation)
Unit of Measure: days
Age 20-29 24.1  (25.8) 9.5  (10.6)
Age 30-39 78.9  (49.5) 73.9  (90.1)
Agge 40-49 98.8  (70.4) 85.0  (66.9)
Age 50+ 60.3  (74.1) 64.1  (66.4)
3.Secondary Outcome
Title Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day
Hide Description The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day
Time Frame 12 weeks prior to release from prison (baseline) to 6 months post release
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Naltrexone, Received 0-3 Injections Placebo, Received 0-3 Injections Extended-release Naltrexone, Received 4-6 Injections Placebo, Received 4-6 Injections
Hide Arm/Group Description:

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.

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.

[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 19 27 14
Mean (Standard Deviation)
Unit of Measure: standard units of alcohol
-16.6  (22.2) -29.6  (27.5) -17.4  (25.0) -14.9  (16.3)
4.Secondary Outcome
Title Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days
Hide Description change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.
Time Frame change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Naltrexone, Received 0-3 Injections Placebo, Received 0-3 Injections Extended-release Naltrexone, Received 4-6 Injections Placebo, Received 4-6 Injections
Hide Arm/Group Description:

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.

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.

[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 40 19 27 14
Mean (Standard Deviation)
Unit of Measure: percent of heavy drinking days
-38.3  (44.8) -51.3  (41.1) -63.6  (38.8) -54.9  (46.9)
5.Other Pre-specified Outcome
Title Mean Change in CD4 Cell Count (Cells/mL)
Hide Description Baseline labs will be drawn while subjects is in prison, one to three months prior to release. Additionally, blood will be drawn every 3 months for 1 year to monitor changes in CD4 cell count.
Time Frame Baseline and every 3 months for 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These data were not able to be collected for analysis.
Arm/Group Title Extended-release Naltrexone, Received 0-3 Injections Placebo, Received 0-3 Injections Extended-release Naltrexone, Received 4-6 Injections Placebo, Received 4-6 Injections
Hide Arm/Group Description:

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.

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.

[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame full study duration, up to 48 weeks post release
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended-release Naltrexone Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Extended-release Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Extended-release Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/67 (0.00%)      0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Extended-release Naltrexone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/67 (13.43%)      2/33 (6.06%)    
Gastrointestinal disorders     
Nausea  [1]  9/67 (13.43%)  22 2/33 (6.06%)  4
General disorders     
headache  [2]  5/67 (7.46%)  14 2/33 (6.06%)  3
Indicates events were collected by systematic assessment
[1]
known medication side affect
[2]
known drug side effect
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
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01077310     History of Changes
Other Study ID Numbers: 0908005572
1R01AA018944 ( U.S. NIH Grant/Contract )
First Submitted: February 19, 2010
First Posted: March 1, 2010
Results First Submitted: August 4, 2016
Results First Posted: November 25, 2016
Last Update Posted: May 30, 2017