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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA018944 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.
INSPIRE is a randomized controlled trial of injectable intramuscular NTX (XR-NTX) versus intramuscular placebo among Human Immunodeficiency (HIV) infected prisoners meeting DSM-IV criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. While the COMBINE trial has demonstrated the effectiveness of oral naltrexone in a group of active alcohol dependent persons in decreasing relapse to alcohol use over placebo, naltrexone has not been studied in people who have a history of current alcohol dependence prior to incarceration, are incarcerated and not actively using alcohol and are likely to return to alcohol use when released. In this study, we conduct a placebo-controlled trial to determine if naltrexone has an effect in this group, which could be important in making the case for having naltrexone available to alcohol dependent or problem drinking HIV+ prisoners prior to release. We will compare their HIV treatment (HIV-1 RNA levels, CD4 count), alcohol treatment (time to relapse to heavy drinking, percent of days drinking, percent of days abstinent and alcohol craving) and HIV risk behavior (sexual and drug-related risks) outcomes. The hypotheses include:
i. XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts.
ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intramuscular naltrexone | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivitrol- Intramuscular naltrexone (depot-formulation) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL | 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. | Baseline to month 6 post release |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Treatment Outcome: Time to Alcohol Relapse | Self reported time to first heavy drinking day after release from incarceration, up to 6 months | Post release |
| Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in CD4 Cell Count (Cells/mL) | 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. | Baseline and every 3 months for 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra A Springer, MD | Yale University | Principal Investigator |
| Frederick L Altice, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Clinical Research | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24384538 | Background | Springer SA, Altice FL, Herme M, Di Paola A. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community. Contemp Clin Trials. 2014 Mar;37(2):209-18. doi: 10.1016/j.cct.2013.12.006. Epub 2013 Dec 31. | |
| 24674234 | Result | Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. J Subst Abuse Treat. 2014 Jul;47(1):35-40. doi: 10.1016/j.jsat.2014.02.008. Epub 2014 Mar 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL | 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. | Logistic regression backward stepwise models were used to find predictors of HIV viral suppression. | Posted | Number | percent of participants | Baseline to month 6 post release |
|
full study duration, up to 48 weeks post release
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | known medication side affect |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principle Investigator | Yale School of Medicine | 203-737-2883 | sandra.springer@yale.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Placebo | Drug | 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. |
|
|
The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day
| 12 weeks prior to release from prison (baseline) to 6 months post release |
| Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days | change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration. | change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release |
| 26560326 | Result | Springer SA, Brown SE, Di Paola A, Altice FL. Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system. Drug Alcohol Depend. 2015 Dec 1;157:158-65. doi: 10.1016/j.drugalcdep.2015.10.023. Epub 2015 Oct 28. |
| 29781884 | Derived | Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):92-100. doi: 10.1097/QAI.0000000000001759. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol use severity by AUDIT | Number | participants |
|
| OG001 | 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. |
|
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| Secondary | Alcohol Treatment Outcome: Time to Alcohol Relapse | Self reported time to first heavy drinking day after release from incarceration, up to 6 months | Posted | Mean | Standard Deviation | days | Post release |
|
|
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| Secondary | Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day | The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day | Posted | Mean | Standard Deviation | standard units of alcohol | 12 weeks prior to release from prison (baseline) to 6 months post release |
|
|
|
| Secondary | Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days | change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration. | Posted | Mean | Standard Deviation | percent of heavy drinking days | change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release |
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|
|
| Other Pre-specified | Mean Change in CD4 Cell Count (Cells/mL) | 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. | These data were not able to be collected for analysis. | Posted | Baseline and every 3 months for 1 year |
|
|
| 0 |
| 67 |
| 9 |
| 67 |
| EG001 | 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. | 0 | 33 | 2 | 33 |
| headache | General disorders | Systematic Assessment | known drug side effect |
|
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| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |
| Agge 40-49 |
|
| Age 50+ |
|