Opioid Use DisorderPhase 3CHOICESNCT01908062
Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
A Phase 3 study testing Extended Release Naltrexone and Treatment As usual in people with Opioid Use Disorder and Alcohol Use Disorder, run by Oregon Health and Science University at 2 sites in 2 countries.
Trial summary
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Opioid Use Disorder, Alcohol Use Disorder
- What is being tested?
- Extended Release Naltrexone and Treatment As usual
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2014to Mar 2015
- Phase
- Phase 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe opioid use disorder and/or alcohol use disorder.
- Be willing to be randomized to antagonist-based therapy or treatment as usual (TAU) for treatment of opioid and/or alcohol use disorders.
- Be HIV-infected as defined by history of positive HIV serology or HIV RNA pcr >10,000 copies/mL).
- Be willing to establish ongoing HIV care at community treatment program(CTP) if not already receiving ongoing care.
- Be willing to initiate antiretroviral therapy (ART) if not already prescribed ART, regardless of CD4 count.
- Be at least 18 years old.
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- Be able to provide written informed consent and HIPAA (if applicable) for medical record abstraction.
- Be able to communicate in English.
- If female, be willing to take measures to avoid becoming pregnant.
Who cannot join
- Individuals will be excluded from pilot study participation if they:
- Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
- Examples include:
- Disabling or terminal medical illness (e.g., active opportunistic infection, uncompensated heart failure, cirrhosis or end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
- Severe, untreated or inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
- Current severe benzodiazepine or other depressant or sedative hypnotic use requiring medical detoxification;
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- Suicidal or homicidal ideation requiring immediate attention.
- Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times upper limit of normal on screening phlebotomy. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
- Have international normalized ratio (INR) > 1.5 or platelet count <100k. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
- Have known allergy or sensitivity to naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluents.
- Anticipate undergoing surgery during study participation.
- Have chronic pain requiring ongoing pain management with opioid analgesics.
- Pending legal action or other reasons that might prevent an individual from completing the study.
- Currently pregnant or breastfeeding.
- Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX, (e.g. excess fat tissue over the buttocks).
- Received methadone or 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 ECG findings that, in the opinion of the study medical clinician would preclude safe participation in the study. Results from ECGs conducted within the past 30 days which are abstracted from medical record information are acceptable.
- Have had treatment with XR-NTX for opioid or alcohol dependence in the 3 months prior to screening.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.
- Conditions
- Opioid Use Disorder, Alcohol Use Disorder
- Being tested
- Extended Release Naltrexone, Treatment As usual
- Keywords
- Substance related disorders, HIV, naltrexone
- Medical subject headings
- Opioid-Related Disorders, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release NaltrexoneDrug
Also called Vivitrol
Treatment As usualOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups. Receives: Other: Treatment As usual |
| Extended Release Naltrexone | Experimental | Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days. Receives: Drug: Extended Release Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization
Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
Measured: 4 weeks
Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks
Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.
Measured: 16 weeks
Secondary outcomes (9)
HIV Viral Suppression at 16 Weeks
Plasma HIV viral load of < 200 copies/mL compared with screening
Measured: 16 weeks
Mean Days of Opioid Use in Past 30 Days
Change in 30 day opioid use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.
Measured: Baseline and 16 weeks
HIV Care Engagement
Change in the proportion of participants prescribed antiretroviral therapy (ART) within 16 weeks following randomization, compared to baseline.
Measured: Baseline and 16 weeks
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Change in liver enzymes between screening and Week 16. AST = Aspartate transaminase ALT = Alanine transaminase
Measured: Baseline and 16 weeks
Number of Participants With Urine Drug Screen (UDS) Positive for Opioids
Measured: Baseline and 16 weeks
Mean Days of Alcohol Use in Past 30 Days
Change in 30 day alcohol use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.
Measured: Baseline and 16 weeks
Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol
Measured: Baseline and 16 weeks
Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16
Measured: 16 weeks
Participant Safety: Precipitated Withdrawal
Proportion of participants assigned to XR-NTX who develop precipitated opioid withdrawal.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
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 (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 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)
- Responsible party
- Principal investigator, P. Todd Korthuis, MD, Oregon Health and Science University
- Investigators
- Philip T Korthuis, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908062
- Sponsor's protocol ID
- NIDA-CTN-0055
- Other IDs
- U10DA015815
- Acronym
- CHOICES
- Status last verified
- Mar 2019
- First submitted
- 23 Jul 2013
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 40342086Korthuis PT, Lum PJ, Vergara-Rodriguez P, Ahamad K, Wood E, Kunkel LE, Oden NL, Lindblad R, Sorensen JL, Arenas V, Ha D, Mandler RN, McCarty D; CTN-0055 CHOICES Investigators. Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial. Addiction. 2017 Jun;112(6):1036-1044. doi: 10.1111/add.13753. Epub 2017 Feb 8.
PubMed 28061017
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
- ClinicalTrials.gov ID
- NCT01908062
- Acronym / sponsor ID
- CHOICES / NIDA-CTN-0055
- Conditions
- Opioid Use Disorder, Alcohol Use Disorder
- Keywords
- Substance related disorders, HIV, naltrexone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment As usualThe current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups. |
| Extended Release Naltrexone | Experimental | Drug: Extended Release NaltrexoneExtended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe opioid use disorder and/or alcohol use disorder.
- Be willing to be randomized to antagonist-based therapy or treatment as usual (TAU) for treatment of opioid and/or alcohol use disorders.
- Be HIV-infected as defined by history of positive HIV serology or HIV RNA pcr >10,000 copies/mL).
- Be willing to establish ongoing HIV care at community treatment program(CTP) if not already receiving ongoing care.
- Be willing to initiate antiretroviral therapy (ART) if not already prescribed ART, regardless of CD4 count.
Key exclusion criteria (19 listed)
- Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
- Disabling or terminal medical illness (e.g., active opportunistic infection, uncompensated heart failure, cirrhosis or end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
- Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times upper limit of normal on screening phlebotomy. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
- Have international normalized ratio (INR) > 1.5 or platelet count <100k. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
- Have known allergy or sensitivity to naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluents.
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 |
|---|---|---|
| Extended Release NaltrexoneAlso: Vivitrol | Drug | Extended Release Naltrexone |
| Treatment As usual | Other | Treatment as Usual |
Primary outcome
Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization
Time frame: 4 weeks
Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks
Time frame: 16 weeks
Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.
9 secondary outcomes
HIV Viral Suppression at 16 Weeks
Time frame: 16 weeks
Mean Days of Opioid Use in Past 30 Days
Time frame: Baseline and 16 weeks
HIV Care Engagement
Time frame: Baseline and 16 weeks
Participant Safety: Change in Liver Enzymes Between Baseline and Week 16
Time frame: Baseline and 16 weeks
Number of Participants With Urine Drug Screen (UDS) Positive for Opioids
Time frame: Baseline and 16 weeks
Mean Days of Alcohol Use in Past 30 Days
Time frame: Baseline and 16 weeks
Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol
Time frame: Baseline and 16 weeks
Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16
Time frame: 16 weeks
Participant Safety: Precipitated Withdrawal
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- 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 28061017Korthuis PT, Lum PJ, Vergara-Rodriguez P, Ahamad K, Wood E, Kunkel LE, Oden NL, Lindblad R, Sorensen JL, Arenas V, Ha D, Mandler RN, McCarty D; CTN-0055 CHOICES Investigators. Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial. Addiction. 2017 Jun;112(6):1036-1044. doi: 10.1111/add.13753. Epub 2017 Feb 8.
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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.
Philip T Korthuis, MD, MPH principal investigator
Oregon Health and Science University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended Release Naltrexone and Treatment As usual in people with Opioid Use Disorder and Alcohol Use Disorder, run by Oregon Health and Science University at 2 sites in 2 countries.
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 9 inclusion and 19 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 phase mean?
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 26 Feb 2019). 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 Successful Initiation of Treatment Within 4 Weeks of Randomization (time frame: 4 weeks). The study lists 2 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 NCT01908062, which also lists 2 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 19 Mar 2019.