Opioid-use DisorderPhase 2/3NCT03275350
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
A Phase 2/3 study testing Naltrexone Injectable Suspension and Treatment as usual in people with Opioid-use Disorder and Hiv, run by Oregon Health and Science University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Hiv
- What is being tested?
- Naltrexone Injectable Suspension and Treatment as usual
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Feb 2018to 8 Nov 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is at least 18 years old
- Participant has provided written informed consent and HIPAA for medical record abstraction
- Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder
- Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder
- Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)
- Willing to establish ongoing HIV care at the site if not already receiving ongoing care
- If female, willing to take at least one evidence-based measure to avoid becoming pregnant
Who cannot join
- Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:
- Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments
- Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview
- Suicidal or homicidal ideation requiring immediate attention
- Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy
- Participant has an international normalized ratio (INR) > 1.5 or platelet count <100k
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- Participant has a known allergy or sensitivity to naloxone, naltrexone, polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol diluent
- Anticipate undergoing surgery during study participation
- Have chronic pain requiring ongoing pain management with opioid analgesics
- If female, currently (at time of consent) pregnant or breastfeeding or planning on conceiving in the coming months
- Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)
- Received methadone of buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening
- Have taken an investigational drug in another study within 30 days of study consent
- Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior to consent
- Are currently in jail, prison or have a pending legal action which may prevent an individual from completing the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University, Bartlett Specialty Clinic
Baltimore, Maryland, 21287
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
University of Kentucky Bluegrass Care Clinic
Lexington, Kentucky, 40536
Jackson Memorial Hospital
Miami, Florida, 33136
Tarzana Treatment Centers
Tarzana, California, 91356
About this study
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.
Read the 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
- Being tested
- Naltrexone Injectable Suspension, Treatment as usual
- Medical subject headings
- Opioid-Related Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone Injectable SuspensionDrug
Six monthly injections of extended-release naltrexone
Treatment as usualOther
Standard treatment for opioid use disorder provided at each HIV clinic
| Study group | Role | What they receive |
|---|---|---|
| XR-NTX | Active comparator | Extended-release naltrexone Receives: Drug: Naltrexone Injectable Suspension |
| TAU | Active comparator | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
HIV-1 RNA <200 copies/ml
Measured: 12 weeks and 24 weeks
Number of Participants With HIV Viral Suppression, Complete Case
HIV-1 RNA <200 copies/ml
Measured: 12 weeks and 24 weeks
Number of Participants With HIV Viral Suppression, Per-protocol
HIV-1 RNA <200 copies/ml
Measured: 12 weeks and 24 weeks
Secondary outcomes (10)
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.
Measured: Baseline and 24 weeks
CD4 Count
Cluster of Differentiation 4
Absolute value of CD4 count at baseline and 24 weeks.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start5 Feb 2018
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Johns Hopkins University, University of Kentucky, Jackson Health System, Tarzana Treatment Centers, Ruth M. Rothstein CORE Center
- Responsible party
- Principal investigator, P. Todd Korthuis, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275350
- Sponsor's protocol ID
- Clinical Trials Network-0067
- Status last verified
- Apr 2022
- First submitted
- 28 Aug 2017
- Last updated
- 27 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
PubMed 40342086Foot C, Korthuis PT, Tsui JI, Luo SX, Chan B, Cook RR. Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder. Addiction. 2024 Jan;119(1):149-157. doi: 10.1111/add.16334. Epub 2023 Sep 15.
PubMed 37712113Hoffman KA, Baker R, Fanucchi LC, Lum PJ, Kunkel LE, Ponce Terashima J, McCarty D, Jacobs P, Korthuis PT. Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis. Addict Sci Clin Pract. 2021 Nov 10;16(1):67. doi: 10.1186/s13722-021-00277-z.
PubMed 34758887
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
- ClinicalTrials.gov ID
- NCT03275350
- Acronym / sponsor ID
- Clinical Trials Network-0067
- Conditions
- Opioid-use Disorder, Hiv
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Johns Hopkins University, University of Kentucky, Jackson Health System, Tarzana Treatment Centers, Ruth M. Rothstein CORE Center
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Posted 27 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XR-NTX | Active comparator | Drug: Naltrexone Injectable SuspensionExtended-release naltrexone |
| TAU | Active comparator | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is at least 18 years old
- Participant has provided written informed consent and HIPAA for medical record abstraction
- Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder
- Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder
- Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)
Key exclusion criteria (15 listed)
- Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:
- Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments
- Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview
- Suicidal or homicidal ideation requiring immediate attention
- Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone Injectable SuspensionSix monthly injections of extended-release naltrexone | Drug | XR-NTX |
| Treatment as usualStandard treatment for opioid use disorder provided at each HIV clinic | Other | TAU |
Primary outcome
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed
Time frame: 12 weeks and 24 weeks
HIV-1 RNA <200 copies/ml
Number of Participants With HIV Viral Suppression, Complete Case
Time frame: 12 weeks and 24 weeks
HIV-1 RNA <200 copies/ml
Number of Participants With HIV Viral Suppression, Per-protocol
Time frame: 12 weeks and 24 weeks
HIV-1 RNA <200 copies/ml
10 secondary outcomes
Veterans Aging Cohort Study (VACS) Index
Time frame: Baseline and 24 weeks
CD4 Count
Time frame: Baseline and 24 weeks
Engagement in HIV Care: Antiretroviral Therapy Prescribed
Time frame: Baseline and 24 weeks
Engagement in HIV Care: 100% Antiretroviral Therapy Adherence
Time frame: 24 weeks
Number of Participants With 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
Time frame: Baseline and 24 weeks
Number of Participants With Multiple Sex Partners in Past 30 Days
Time frame: Baseline and 24 weeks
Engagement in HIV Care: Quality of Life
Time frame: Baseline and 24 weeks
Average Number of Self-Reported Days of Opioid Use in Last 30 Days
Time frame: Between baseline and 24 weeks
Number of Participants Who Test Positive for Opioids at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40342086Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.
- Derived from this study: PubMed 37712113Foot C, Korthuis PT, Tsui JI, Luo SX, Chan B, Cook RR. Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder. Addiction. 2024 Jan;119(1):149-157. doi: 10.1111/add.16334. Epub 2023 Sep 15.
- Derived from this study: PubMed 34758887Hoffman KA, Baker R, Fanucchi LC, Lum PJ, Kunkel LE, Ponce Terashima J, McCarty D, Jacobs P, Korthuis PT. Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis. Addict Sci Clin Pract. 2021 Nov 10;16(1):67. doi: 10.1186/s13722-021-00277-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naltrexone Injectable Suspension and Treatment as usual in people with Opioid-use Disorder and Hiv, run by Oregon Health and Science University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed (time frame: 12 weeks and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03275350, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.