| Primary | Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month | 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. | 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. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Welch's T Test | | 0.431 | | | | | | | | | | | | | | Superiority | | |
|
| Secondary | Particpants Who Had Undetectable HIV-1 RNA Levels at Less Than 50 Copies/mL | 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. | 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. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | CD4 Cell Count (Cells/mL) | 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. | 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. | Posted | | Mean | Standard Deviation | cells/ml | | Baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Time to Opioid Relapse or End of Intervention | 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. | 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. | Posted | | Median | Full Range | days | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Addiction Severity | 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. | 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). | Posted | | Mean | Standard Deviation | units on a scale | | baseline, and 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Craving for Opioids | 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. | 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). | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Antiretroviral Therapy (ART) Adherence 100% | Number of subjects with 100% adherence at 6 months measured using Visual Analogue Scale: 0% to 100% | 56 participants with missing data were considered as failure - meaning - with adherence less than 100%, and included into the analysis. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Participants With Opiate Abstinence Via By Doing Urine Toxicology Test | Percent of subjects with no opiate use at 6 month. Missing data was treated as failure (opiate positive). | | Posted | | Count of Participants | | Participants | | 6 month | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Opioid Abstinence at 6 Months for Those With More Than 4 Injections | 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. | 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. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Participants With 3 or Fewer XR-NTX Injections | All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections | | OG001 | 4 or More XR-NTX Injections | All participants who received 4 or more XR-NTX injections |
| |
| Secondary | ART Adherence for 4 or More Injections XR-NTX Versus Placebo and 3 or Less Injections of XR-NTX | 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. | All client with missing data at 6 months were considered as failure - meaning - they had less than 100% ART adherence. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo + Participants With 3 or Fewer XR-NTX Injections | All participants receiving Placebo as well as participants who received 3 or less XR-NTX injections | | OG001 | 4 or More XR-NTX Injections | All participants who received 4 or more XR-NTX injections |
| |