Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 44 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations (NewHope)

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: NCT01246401
Recruitment Status : Completed
First Posted : November 23, 2010
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
Baystate Medical Center
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 HIV
AIDS
Opioid Dependence
Drug Dependence
Intervention Drug: Extended-Release Naltrexone
Enrollment 151
Recruitment Details 151 subjects consented, 58 lost before randomization
Pre-assignment Details  
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Period Title: Overall Study
Started 66 27
Completed 66 27
Not Completed 0 0
Arm/Group Title Extended-Release Naltrexone Placebo Total
Hide Arm/Group Description

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Total of all reporting groups
Overall Number of Baseline Participants 66 27 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 27 participants 93 participants
46.6  (8.3) 43.9  (7.8) 45.8  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 27 participants 93 participants
Female
11
  16.7%
6
  22.2%
17
  18.3%
Male
55
  83.3%
21
  77.8%
76
  81.7%
Housing status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 27 participants 93 participants
Stable
23
  34.8%
11
  40.7%
34
  36.6%
Unstable
19
  28.8%
4
  14.8%
23
  24.7%
Homeless
24
  36.4%
12
  44.4%
36
  38.7%
Currently prescribed ART  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 27 participants 93 participants
58
  87.9%
24
  88.9%
82
  88.2%
Alcohol Use Severity (AUDIT score)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 27 participants 93 participants
Abstinent or Low-Risk Drinking
42
  63.6%
23
  85.2%
65
  69.9%
Hazardous Drinking
11
  16.7%
2
   7.4%
13
  14.0%
Harmful Drinking
2
   3.0%
0
   0.0%
2
   2.2%
Possible Dependence
10
  15.2%
2
   7.4%
12
  12.9%
Missing
1
   1.5%
0
   0.0%
1
   1.1%
Opioid craving   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 66 participants 27 participants 93 participants
3.2  (3.6) 3.5  (3.8) 3.3  (3.6)
[1]
Measure Description: Opioid craving scale: a 10 item likert scale from 0 to 10 with 10 being highest craving for opioids and 0 representing no craving. Mean scores taken for each group.
Years Reported use of substances  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 27 participants 93 participants
Alcohol 13.5  (15.2) 9.2  (11.6) 12.2  (14.3)
Cannabis 14  (14.3) 12.8  (12.5) 13.6  (13.7)
Cocaine 17.5  (11.4) 18.7  (8.6) 17.9  (10.6)
Heroin 20.1  (11.2) 18.4  (10.2) 19.6  (10.9)
Other Opioids 2.8  (7.2) 3.2  (5.4) 2.9  (6.7)
1.Primary Outcome
Title Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month
Hide Description Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 66 27
Measure Type: Count of Participants
Unit of Measure: Participants
45
  68.2%
16
  59.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended-Release Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments [Not Specified]
Method Welch's T Test
Comments [Not Specified]
2.Secondary Outcome
Title Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL
Hide Description Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additionally, labs will be drawn every 3 months for 1 year to monitor changes in HIV-1 RNA levels. Treatment time period was the first 6 months where the primary outcome data will be based on.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 80 participants had viral load data at 6 months (56 in XR-NTX group and 24 in Placebo group). The remaining 13 participants (10 in XR-NTX group and 3 in Placebo group) with missing viral load data at 6 months were considered as failure - meaning - having a viral load of 400 or more. Thus included into the final analysis.
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 66 27
Measure Type: Count of Participants
Unit of Measure: Participants
40
  60.6%
11
  40.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended-Release Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method Welch's T Test
Comments [Not Specified]
3.Secondary Outcome
Title CD4 Cell Count (Cells/mL)
Hide Description Baseline labs will be drawn while subject is in prison, one to three months prior to release. Additional labs will be drawn every 3 months for 1 year to monitor changes in CD4 levels.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was collected via labs. At month 6, due to attrition, data was only available for a total of 46 subjects. These include, 14 in Placebo and 32 in Extended-Release Naltrexone. The mean and STD are presented below.
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 66 27
Mean (Standard Deviation)
Unit of Measure: cells/ml
Baseline mean CD4 count Number Analyzed 66 participants 27 participants
465.2  (273.8) 580.8  (336.8)
Month 6 mean CD4 count Number Analyzed 32 participants 14 participants
462  (306.6) 485.6  (257.3)
4.Secondary Outcome
Title Time to Opioid Relapse or End of Intervention
Hide Description Measuring days to first relapse based on self reported opioids (heroin) use within the 6 month (180 days) intervention period. If participants had no follow-up visits, and thus no self reported opiate use, they were treated as missing. Those who did not relapse within the 6 month intervention period were treated as having 180 days until relapse.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data collected via Time Line Fall Back (TLFB). 15 in XR-NTX group and 4 in Placebo did not have data because of attrition - treated as missing. An additional 19 people in the treatment arm and 9 in placebo filled out the TLFB at 9 or 12 months, and this data was used to fill in missing information.
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 51 23
Median (Full Range)
Unit of Measure: days
137
(0 to 168)
29
(0 to 168)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Extended-Release Naltrexone, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Wilcoxon one sided
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Addiction Severity
Hide Description

The Addiction Severity Index (ASI) questionnaire will be used to assess addiction severity. The ASI composite scoreprovides reliable and valid measure of patient status in a particular module of interest which can then be usecompared at the beginning of treatment to the evaluation endpoint to note the improvement or lack thereof. In this assessment the drug composite score was calculated using algorithm by Treatment Research Institute. If the score increases then it shows increase in severity where as if it decreases then it shows decrease in severity for that measured module. The scale ranges from 0 to 1.

The mean composite scores for drug use from baseline to 6 months were compared using Nonparametric test.

Time Frame baseline, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
An additional subject's data from the experimental group was not collected at baseline. For the 6 months data, the total number of participants with completed assessment used for the analysis was 46 (31 in XR-NTX group and 15 in Placebo group).
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 65 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline Number Analyzed 65 participants 27 participants
0.37  (0.16) 0.42  (0.14)
6 month Number Analyzed 31 participants 15 participants
0.12  (0.13) 0.16  (0.16)
6.Secondary Outcome
Title Craving for Opioids
Hide Description Craving at baseline compared to 6 month. This is assessed through a self report scale rated 0 to 10; 0 meaning not craving and 10 meaning highest craving. Change in craving score was categorized as 1)no change between baseline and 6 month; 2)increased craving - baseline craving was reported lower than at 6 month; 3)decreased craving - baseline craving was reported higher than 6 month craving.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data available at 6 month determined who was included into the analysis. In this case a total of 47 data points (those with both baseline and 6 month data points) were included into the analysis (32 Extended-Release Naltrexone and 15 Placebo).
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 32 15
Measure Type: Count of Participants
Unit of Measure: Participants
No change
12
  37.5%
7
  46.7%
Increased craving at 6 mo
6
  18.8%
3
  20.0%
Decreased craving at 6 mo
14
  43.8%
5
  33.3%
7.Secondary Outcome
Title Antiretroviral Therapy (ART) Adherence 100%
Hide Description Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100%
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
56 participants with missing data were considered as failure - meaning - with adherence less than 100%, and included into the analysis.
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 66 27
Measure Type: Count of Participants
Unit of Measure: Participants
25
  37.9%
12
  44.4%
8.Secondary Outcome
Title Participants With Opiate Abstinence Via By Doing Urine Toxicology Test
Hide Description Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive).
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description:

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Overall Number of Participants Analyzed 66 27
Measure Type: Count of Participants
Unit of Measure: Participants
NEG Opi at Day of Release
44
  66.7%
17
  63.0%
NEG Opi at 6 month
13
  19.7%
5
  18.5%
9.Secondary Outcome
Title Opioid Abstinence at 6 Months for Those With More Than 4 Injections
Hide Description Based on self reported opioids (heroin) use. All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections were compared to those who receive 4 or more XR-NTX injection.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Collected via Time Line Fall Back (TLFB). Total N analyzed is 74. 12 of the clients had initial or some TLFB data indicating relapse but were counted as lost at 6 months for outcome 4. 19 Clients did not have TLFB data or if they did within 6 month it did not indicate any relapse. These were treated as missing and not included in analysis.
Arm/Group Title Placebo + Participants With 3 or Fewer XR-NTX Injections 4 or More XR-NTX Injections
Hide Arm/Group Description:
All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
All participants who received 4 or more XR-NTX injections
Overall Number of Participants Analyzed 58 16
Measure Type: Count of Participants
Unit of Measure: Participants
18
  31.0%
13
  81.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo + Participants With 3 or Fewer XR-NTX Injections, 4 or More XR-NTX Injections
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03962
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX
Hide Description The arm/group number of the participants vary from the primary outcome because this is a treatment effect analysis. All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.
Arm/Group Title Placebo + Participants With 3 or Fewer XR-NTX Injections 4 or More XR-NTX Injections
Hide Arm/Group Description:
All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections
All participants who received 4 or more XR-NTX injections
Overall Number of Participants Analyzed 77 16
Measure Type: Count of Participants
Unit of Measure: Participants
23
  29.9%
14
  87.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended-Release Naltrexone Placebo
Hide Arm/Group Description

Participants will receive intramuscular (IM) injections of Naltrexone once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

Participants will receive IM injections of Placebo once monthly for 6 months, the first injection being prior release

Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg

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 (%) Affected / at Risk (%)
Total   0/66 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Extended-Release Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/66 (19.70%)   4/27 (14.81%) 
Blood and lymphatic system disorders     
Signs of Edema   2/66 (3.03%)  2/27 (7.41%) 
Gastrointestinal disorders     
Nausea   1/66 (1.52%)  1/27 (3.70%) 
Vomiting   1/66 (1.52%)  0/27 (0.00%) 
Diarrhea   3/66 (4.55%)  0/27 (0.00%) 
General disorders     
Fatigue   6/66 (9.09%)  1/27 (3.70%) 
Metabolism and nutrition disorders     
Decreased Apetite   2/66 (3.03%)  1/27 (3.70%) 
Increased Apetite   2/66 (3.03%)  1/27 (3.70%) 
Musculoskeletal and connective tissue disorders     
Immediate Injection Reaction   10/66 (15.15%)  2/27 (7.41%) 
Nervous system disorders     
Headache   5/66 (7.58%)  0/27 (0.00%) 
Skin and subcutaneous tissue disorders     
Injection Site Reaction   2/66 (3.03%)  0/27 (0.00%) 
Skin and Soft Tissue Infection   2/66 (3.03%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sandra Springer
Organization: Yale University
EMail: sandra.springer@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01246401     History of Changes
Other Study ID Numbers: 1007007169
First Submitted: November 22, 2010
First Posted: November 23, 2010
Results First Submitted: February 27, 2017
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017