Trial Outcomes & Findings for Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations (NCT NCT01246401)
NCT ID: NCT01246401
Last Updated: 2020-03-19
Results Overview
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.
COMPLETED
PHASE1/PHASE2
151 participants
6 months
2020-03-19
Participant Flow
151 subjects consented, 58 lost before randomization
Participant milestones
| Measure |
Extended-Release Naltrexone
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
|
Placebo
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 Study
STARTED
|
66
|
27
|
|
Overall Study
COMPLETED
|
66
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Baseline characteristics by cohort
| Measure |
Extended-Release Naltrexone
n=66 Participants
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
|
Placebo
n=27 Participants
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
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Housing status
Stable
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Housing status
Unstable
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Housing status
Homeless
|
24 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Currently prescribed ART
|
58 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Alcohol Use Severity (AUDIT score)
Abstinent or Low-Risk Drinking
|
42 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Alcohol Use Severity (AUDIT score)
Hazardous Drinking
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Alcohol Use Severity (AUDIT score)
Harmful Drinking
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Alcohol Use Severity (AUDIT score)
Possible Dependence
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Alcohol Use Severity (AUDIT score)
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Opioid craving
|
3.2 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Years Reported use of substances
Alcohol
|
13.5 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
12.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Years Reported use of substances
Cannabis
|
14 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
12.8 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
13.6 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Years Reported use of substances
Cocaine
|
17.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
18.7 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
17.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Years Reported use of substances
Heroin
|
20.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
18.4 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
19.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Years Reported use of substances
Other Opioids
|
2.8 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
3.2 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
2.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=66 Participants
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
|
Placebo
n=27 Participants
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
|
|---|---|---|
|
Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month
|
45 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=66 Participants
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
|
Placebo
n=27 Participants
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
|
|---|---|---|
|
Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL
|
40 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=66 Participants
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
|
Placebo
n=27 Participants
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
|
|---|---|---|
|
CD4 Cell Count (Cells/mL)
Baseline mean CD4 count
|
465.2 cells/ml
Standard Deviation 273.8
|
580.8 cells/ml
Standard Deviation 336.8
|
|
CD4 Cell Count (Cells/mL)
Month 6 mean CD4 count
|
462 cells/ml
Standard Deviation 306.6
|
485.6 cells/ml
Standard Deviation 257.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=51 Participants
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
|
Placebo
n=23 Participants
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
|
|---|---|---|
|
Time to Opioid Relapse or End of Intervention
|
137 days
Interval 0.0 to 168.0
|
29 days
Interval 0.0 to 168.0
|
SECONDARY outcome
Timeframe: baseline, and 6 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=65 Participants
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
|
Placebo
n=27 Participants
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
|
|---|---|---|
|
Addiction Severity
baseline
|
0.37 units on a scale
Standard Deviation 0.16
|
0.42 units on a scale
Standard Deviation 0.14
|
|
Addiction Severity
6 month
|
0.12 units on a scale
Standard Deviation 0.13
|
0.16 units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=32 Participants
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
|
Placebo
n=15 Participants
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
|
|---|---|---|
|
Craving for Opioids
No change
|
12 Participants
|
7 Participants
|
|
Craving for Opioids
Increased craving at 6 mo
|
6 Participants
|
3 Participants
|
|
Craving for Opioids
Decreased craving at 6 mo
|
14 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 56 participants with missing data were considered as failure - meaning - with adherence less than 100%, and included into the analysis.
Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100%
Outcome measures
| Measure |
Extended-Release Naltrexone
n=66 Participants
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
|
Placebo
n=27 Participants
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
|
|---|---|---|
|
Antiretroviral Therapy (ART) Adherence 100%
|
25 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 6 monthPercent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive).
Outcome measures
| Measure |
Extended-Release Naltrexone
n=66 Participants
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
|
Placebo
n=27 Participants
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
|
|---|---|---|
|
Participants With Opiate Abstinence Via By Doing Urine Toxicology Test
NEG Opi at Day of Release
|
44 Participants
|
17 Participants
|
|
Participants With Opiate Abstinence Via By Doing Urine Toxicology Test
NEG Opi at 6 month
|
13 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=58 Participants
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
|
Placebo
n=16 Participants
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
|
|---|---|---|
|
Opioid Abstinence at 6 Months for Those With More Than 4 Injections
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence.
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.
Outcome measures
| Measure |
Extended-Release Naltrexone
n=77 Participants
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
|
Placebo
n=16 Participants
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
|
|---|---|---|
|
ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX
|
23 Participants
|
14 Participants
|
Adverse Events
Extended-Release Naltrexone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extended-Release Naltrexone
n=66 participants at risk
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
|
Placebo
n=27 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.6%
5/66
|
0.00%
0/27
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
3.0%
2/66
|
0.00%
0/27
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66
|
3.7%
1/27
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66
|
0.00%
0/27
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
3/66
|
0.00%
0/27
|
|
Metabolism and nutrition disorders
Decreased Apetite
|
3.0%
2/66
|
3.7%
1/27
|
|
Metabolism and nutrition disorders
Increased Apetite
|
3.0%
2/66
|
3.7%
1/27
|
|
General disorders
Fatigue
|
9.1%
6/66
|
3.7%
1/27
|
|
Skin and subcutaneous tissue disorders
Skin and Soft Tissue Infection
|
3.0%
2/66
|
3.7%
1/27
|
|
Blood and lymphatic system disorders
Signs of Edema
|
3.0%
2/66
|
7.4%
2/27
|
|
Musculoskeletal and connective tissue disorders
Immediate Injection Reaction
|
15.2%
10/66
|
7.4%
2/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place