Who is sponsoring NCT03275350?

NCT03275350 is sponsored by Oregon Health and Science University.

What drugs are being tested in NCT03275350?

Interventions in NCT03275350: Naltrexone Injectable Suspension, Treatment as usual.

What condition does NCT03275350 study?

NCT03275350 studies Opioid-use Disorder, Hiv.

Is NCT03275350 still recruiting?

NCT03275350 is currently completed. Last updated 27 April 2022.

Are results published for NCT03275350?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-27 · How we verify

NCT03275350

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Results posted Last updated 27 April 2022

What this trial tests

Phase 2, PHASE3 trial testing Naltrexone Injectable Suspension in Opioid-use Disorder in 114 participants. Completed in 8 November 2019.

Timeline

5 February 2018

Primary endpoint
8 November 2019

8 November 2019

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	114
Start date	5 February 2018
Primary completion	8 November 2019
Estimated completion	8 November 2019
Sites	5 locations across United States

Drugs / interventions tested

Naltrexone Injectable Suspension — full drug profile →
Treatment as usual

Conditions studied

Opioid-use Disorder — all drugs for Opioid-use Disorder →
Hiv — all drugs for Hiv →

Sponsor

Oregon Health and Science University

Who can join

18 and older, any sex, with Opioid-use Disorder or Hiv. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed Primary · 12 weeks and 24 weeks

HIV-1 RNA \<200 copies/ml

12 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	23
Treatment as Usual (TAU)	21

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	29
Treatment as Usual (TAU)	29

Number of Participants With HIV Viral Suppression, Complete Case Primary · 12 weeks and 24 weeks

HIV-1 RNA \<200 copies/ml

12 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	23
Treatment as Usual (TAU)	19

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	26
Treatment as Usual (TAU)	26

Number of Participants With HIV Viral Suppression, Per-protocol Primary · 12 weeks and 24 weeks

HIV-1 RNA \<200 copies/ml

12 weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	11
Treatment as Usual (TAU)	16

24 weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	15
Treatment as Usual (TAU)	23

Veterans Aging Cohort Study (VACS) Index Secondary · Baseline and 24 weeks

Absolute value of participant VACS Index at baseline and 24 weeks Veterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.

Baseline

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	65.1	± 18.1
Treatment as Usual (TAU)	68.4	± 24.7

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	54.4	± 20.7
Treatment as Usual (TAU)	63.5	± 25.4

CD4 Count Secondary · Baseline and 24 weeks

Cluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks.

Baseline

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	380.7	± 248.2
Treatment as Usual (TAU)	439.8	± 336.6

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	459.1	± 249.1
Treatment as Usual (TAU)	505.1	± 349.1

Engagement in HIV Care: Antiretroviral Therapy Prescribed Secondary · Baseline and 24 weeks

Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.

Baseline

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	37
Treatment as Usual (TAU)	46

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	45
Treatment as Usual (TAU)	43

Engagement in HIV Care: 100% Antiretroviral Therapy Adherence Secondary · 24 weeks

Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	16
Treatment as Usual (TAU)	13

Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks Secondary · 24 weeks

At least 1 HIV care visit in past 12 weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	31
Treatment as Usual (TAU)	29

Number of Participants Who Had Unprotected Sex in Past 30 Days Secondary · Baseline and 24 weeks

Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).

Baseline

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	15
Treatment as Usual (TAU)	16

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	9
Treatment as Usual (TAU)	9

Number of Participants With Multiple Sex Partners in Past 30 Days Secondary · Baseline and 24 weeks

Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).

Baseline

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	10
Treatment as Usual (TAU)	6

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	5
Treatment as Usual (TAU)	6

Engagement in HIV Care: Quality of Life Secondary · Baseline and 24 weeks

Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24. Minimum value: 0 Maximum value: 100 Higher scores mean a better outcome

Baseline

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	58	± 19.1
Treatment as Usual (TAU)	64.3	± 17.6

24 Weeks

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	67.9	± 21.2
Treatment as Usual (TAU)	71.2	± 19.1

Average Number of Self-Reported Days of Opioid Use in Last 30 Days Secondary · Between baseline and 24 weeks

Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).

Intent-to-treat

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	11.73	0 – 30
Treatment as Usual (TAU)	14.81	0 – 30

Per-protocol

Group	Value	95% CI
Extended-release Naltrexone (XR-NTX)	6.02	0 – 30
Treatment as Usual (TAU)	13.58	0 – 30

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Extended-release Naltrexone (XR-NTX)

Serious: 5/55 (9%)

Deaths: 2/55

Treatment as Usual (TAU)

Serious: 7/59 (12%)

Deaths: 1/59

Serious adverse events (6 terms)

Reaction	System	Extended-release Naltrexon…	Treatment as Usual (TAU)
Infections	Infections and infestations	—	—
Psychiatric disorders	Psychiatric disorders	—	—
Injury, poisoning and procedural complications	Injury, poisoning and procedural complications	—	—
Vascular disorders	Vascular disorders	—	—
Respiratory disorders	Respiratory, thoracic and mediastinal disorders	—	—
Neoplasms benign, malignant and unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Extended-release Naltrexon…	Treatment as Usual (TAU)
Infections	Infections and infestations	—	—
Gastrointestinal disorders	Gastrointestinal disorders	—	—
Injury	Injury, poisoning and procedural complications	—	—
Respiratory disorders	Respiratory, thoracic and mediastinal disorders	—	—
Psychiatric disorders	Psychiatric disorders	—	—
Nervous system disorders	Nervous system disorders	—	—

Most-reported serious reactions: Infections, Psychiatric disorders, Injury, poisoning and procedural complications, Vascular disorders, Respiratory disorders, Neoplasms benign, malignant and unspecified.

Data from ClinicalTrials.gov NCT03275350 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.
Hoffman KA, Baker R, Kunkel LE, Waddell EN, et al · · 2019 · cited 30× · PMID 31752905 · DOI 10.1186/s12913-019-4721-x
HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.
Korthuis PT, Cook RR, Lum PJ, Waddell EN, et al · · 2022 · cited 20× · PMID 35129242 · DOI 10.1111/add.15836
Associations between fentanyl use and initiation, persistence, and retention on medications for opioid use disorder among people living with uncontrolled HIV disease.
Cook RR, Torralva R, King C, Lum PJ, et al · · 2021 · cited 14× · PMID 34600253 · DOI 10.1016/j.drugalcdep.2021.109077
Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder.
Foot C, Korthuis PT, Tsui JI, Luo SX, et al · · 2024 · cited 8× · PMID 37712113 · DOI 10.1111/add.16334
Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis.
Hoffman KA, Baker R, Fanucchi LC, Lum PJ, et al · · 2021 · cited 7× · PMID 34758887 · DOI 10.1186/s13722-021-00277-z
Treatment Initiation, Substance Use Trajectories, and the Social Determinants of Health in Persons Living With HIV Seeking Medication for Opioid Use Disorder.
Cook RR, Jaworski EN, Hoffman KA, Waddell EN, et al · · 2023 · cited 3× · PMID 37842910 · DOI 10.1177/08897077231200745

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03275350 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oregon Health and Science University
Last refreshed: 27 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03275350.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03275350

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (6 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Opioid-use Disorder

Other Oregon Health and Science University trials

Verify against primary sources