NCT03275350

Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.

Detailed description

The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care clinics. The study is an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in HIV-infected participants with untreated opioid use disorder. Each participant will be engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and enrollment procedures.

Conditions

• Opioid-use Disorder
• Hiv

Interventions

Type	Name	Description
DRUG	Naltrexone Injectable Suspension	Six monthly injections of extended-release naltrexone
OTHER	Treatment as usual	Standard treatment for opioid use disorder provided at each HIV clinic

Timeline

• Start date: 2018-02-05
• Primary completion: 2019-11-08
• Completion: 2019-11-08
• First posted: 2017-09-07
• Last updated: 2022-04-27
• Results posted: 2022-04-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study