NCT01246401: NewHope

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

Completed Phase 1/Phase 2 Results posted Last updated 4 March 2020

What this trial tests

Phase 1/Phase 2 trial testing Extended-Release Naltrexone in HIV in 151 participants. Completed in 1 July 2016.

Timeline

1 March 2011

Primary endpoint
1 March 2016

1 July 2016

Quick facts

Lead sponsor	Yale University
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	151
Start date	1 March 2011
Primary completion	1 March 2016
Estimated completion	1 July 2016
Sites	3 locations across United States

Drugs / interventions tested

• Extended-Release Naltrexone

Conditions studied

• HIV — all drugs for HIV →
• AIDS — all drugs for AIDS →
• Opioid Dependence — all drugs for Opioid Dependence →
• Drug Dependence — all drugs for Drug Dependence →

Sponsor

Yale University

Who can join

18 and older, any sex, with HIV or AIDS. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Participants Who Had Undetectable HIV-1 RNA Levels at Less Than 400 Copies/mL at Six Month
  Time frame: 6 months
  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.

Sponsor's own description

Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for opioid dependence who are transitioning from the structure of a correctional setting to the community.

Hypotheses:

i. XR-NTX will result in improved HIV clinical outcomes, including lower changes in HIV-1 RNA levels, higher CD4 counts and higher rates of retention in care.

ii. XR-NTX will result in improved opioid treatment outcomes, including longer time to opioid relapse, lower addiction severity and lower craving for opioid.

iii. XR-NTX will result in reduced drug- and sex-related HIV risk behaviors compared to the control group.

iv. XR-NTX will result in decreased rates of reincarceration after 12 months of release to the community.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical care of incarcerated people with HIV, viral hepatitis, or tuberculosis.
   Rich JD, Beckwith CG, Macmadu A, Marshall BDL, et al · · 2016 · cited 88× · PMID 27427452 · DOI 10.1016/s0140-6736(16)30379-8
2. Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial.
   Springer SA, Di Paola A, Azar MM, Barbour R, et al · · 2018 · cited 83× · PMID 29373393 · DOI 10.1097/qai.0000000000001634
3. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community.
   Di Paola A, Lincoln T, Skiest DJ, Desabrais M, et al · · 2014 · cited 30× · PMID 25240704 · DOI 10.1016/j.cct.2014.09.002
4. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone.
   Vagenas P, Di Paola A, Herme M, Lincoln T, et al · · 2014 · cited 24× · PMID 24674234 · DOI 10.1016/j.jsat.2014.02.008
5. Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial.
   Lee JD, Friedmann PD, Boney TY, Hoskinson RA, et al · · 2015 · cited 21× · PMID 25602580 · DOI 10.1016/j.cct.2015.01.005
6. The relationship between reincarceration and treatment of opioid use disorder with extended-release naltrexone among persons with HIV.
   Parchinski K, Di Paola A, Wilson AP, Springer SA. · · 2023 · cited 3× · PMID 37159815 · DOI 10.1016/j.dadr.2023.100159