A Phase 2/3 interventional study of Naltrexone Injectable Suspension and Treatment as usual in Opioid-use Disorder and Hiv, sponsored by Oregon Health and Science University. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-27.
Sponsored by Oregon Health and Science University · Phase 2/3, Interventional, and Treatment
Among 52 studies testing naltrexone in Opioid-Related Disorders — 1 open to participants now, 2 under way, none of them phase 3. Naltrexone · Opioid-Related Disorders.
Among the 52 studies testing naltrexone in Opioid-Related Disorders, this one is the 20th largest by enrollment, is one of 4 that started in 2018, is one of 7 in phase 2/3, and was the 42nd registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 114 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →1 of the 52 studies testing naltrexone in Opioid-Related Disorders is open now.
Naltrexone: first FDA approval 1984 (REVIA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →52 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 4 started in 2018.
Median enrollment 61 across the 52 interventional studies. Of the 46 that completed or were terminated, 27 (59%) have results posted.
11 of 52 have an industry lead sponsor. The 10 most frequent:
Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Oregon Health and Science University has 4 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
1 of the studies testing naltrexone in Opioid-Related Disorders that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04464980NYU Langone HealthOptimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) | 2026-12-31 |
Among the 52 studies testing naltrexone in Opioid-Related Disorders, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Extended-release naltrexone
Drug: Naltrexone Injectable Suspension
Treatment as usual
Other: Treatment as usual
Six monthly injections of extended-release naltrexone
Standard treatment for opioid use disorder provided at each HIV clinic
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
HIV-1 RNA \<200 copies/ml
Time frame: 12 weeks and 24 weeks
Number of Participants With HIV Viral Suppression, Complete Case
HIV-1 RNA \<200 copies/ml
Time frame: 12 weeks and 24 weeks
Number of Participants With HIV Viral Suppression, Per-protocol
HIV-1 RNA \<200 copies/ml
Time frame: 12 weeks and 24 weeks
Veterans Aging Cohort Study (VACS) Index
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.
Time frame: Baseline and 24 weeks
CD4 Count
Cluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks.
Time frame: Baseline and 24 weeks
Engagement in HIV Care: Antiretroviral Therapy Prescribed
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.
Time frame: Baseline and 24 weeks
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
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.
Time frame: 24 weeks
Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks
At least 1 HIV care visit in past 12 weeks
Time frame: 24 weeks
Number of Participants Who Had Unprotected Sex in Past 30 Days
Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Time frame: Baseline and 24 weeks
Number of Participants With Multiple Sex Partners in Past 30 Days
Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
Time frame: Baseline and 24 weeks
Engagement in HIV Care: Quality of Life
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
Time frame: Baseline and 24 weeks
Average Number of Self-Reported Days of Opioid Use in Last 30 Days
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).
Time frame: Between baseline and 24 weeks
Number of Participants Who Test Positive for Opioids at 24 Weeks
Number and percent of participants with UDS positive for opioids at 24 weeks.
Time frame: 24 weeks
| Milestone | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Started | 55 | 59 |
| Completed | 47 | 51 |
| Not completed | 8 | 8 |
| Withdrew: Lost to follow-up | 4 | 6 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Incarcerated | 1 | 1 |
HIV-1 RNA \<200 copies/ml
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| 12 Weeks | 23 | 21 |
| 24 Weeks | 29 | 29 |
HIV-1 RNA \<200 copies/ml
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| 12 Weeks | 23 | 19 |
| 24 Weeks | 26 | 26 |
HIV-1 RNA \<200 copies/ml
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| 12 weeks | 11 | 16 |
| 24 weeks | 15 | 23 |
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.
| score on a scale | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Baseline | 65.1 ± 18.1 | 68.4 ± 24.7 |
| 24 Weeks | 54.4 ± 20.7 | 63.5 ± 25.4 |
Cluster of Differentiation 4 Absolute value of CD4 count at baseline and 24 weeks.
| cells/mm3 | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Baseline | 380.7 ± 248.2 | 439.8 ± 336.6 |
| 24 Weeks | 459.1 ± 249.1 | 505.1 ± 349.1 |
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.
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Baseline | 37 | 46 |
| 24 Weeks | 45 | 43 |
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.
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Engagement in HIV Care: 100% Antiretroviral Therapy Adherence | 16 | 13 |
At least 1 HIV care visit in past 12 weeks
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks | 31 | 29 |
Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Baseline | 15 | 16 |
| 24 Weeks | 9 | 9 |
Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Baseline | 10 | 6 |
| 24 Weeks | 5 | 6 |
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
| score on a scale | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Baseline | 58 ± 19.1 | 64.3 ± 17.6 |
| 24 Weeks | 67.9 ± 21.2 | 71.2 ± 19.1 |
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).
| days | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Intent-to-treat | 11.73 (0 to 30) | 14.81 (0 to 30) |
| Per-protocol | 6.02 (0 to 30) | 13.58 (0 to 30) |
Number and percent of participants with UDS positive for opioids at 24 weeks.
| Participants | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| Intent-to-treat | 34 | 40 |
| Per-protocol | 10 | 30 |
Collected over 24 weeks. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Extended-release Naltrexone (XR-NTX) | 2/55 (3.6%) | 5/55 (9.1%) | 11/55 (20%) |
| Treatment as Usual (TAU) | 1/59 (1.7%) | 7/59 (11.9%) | 7/59 (11.9%) |
| Event | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| InfectionsInfections and infestations | 2/55 | 3/59 |
| Psychiatric disordersPsychiatric disorders | 2/55 | 1/59 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 0/55 | 2/59 |
| Vascular disordersVascular disorders | 1/55 | 0/59 |
| Respiratory disordersRespiratory, thoracic and mediastinal disorders | 1/55 | 0/59 |
| Neoplasms benign, malignant and unspecifiedNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/55 | 1/59 |
| Event | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) |
|---|---|---|
| InfectionsInfections and infestations | 2/55 | 5/59 |
| Gastrointestinal disordersGastrointestinal disorders | 3/55 | 0/59 |
| Respiratory disordersRespiratory, thoracic and mediastinal disorders | 2/55 | 1/59 |
| Psychiatric disordersPsychiatric disorders | 2/55 | 1/59 |
| Nervous system disordersNervous system disorders | 2/55 | 0/59 |
| InjuryInjury, poisoning and procedural complications | 1/55 | 2/59 |
| Age, Continuous(years) | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Mean | 48 ± 10.8 | 46 ± 11.5 | 47 ± 11.1 |
| Sex: Female, Male(Participants) | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Female | 23 | 20 | 43 |
| Male | 32 | 39 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 5 | 14 |
| Not Hispanic or Latino | 46 | 54 | 100 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 30 | 34 | 64 |
| White | 19 | 23 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 2 | 8 |
| HIV Viral Load(log10 copies/mL) | Extended-release Naltrexone (XR-NTX) | Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Mean | 4.0 ± 0.9 | 4.0 ± 1.1 | 4.0 ± 1.0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Naltrexone
Oregon Health and Science University →