Opioid Use DisorderNCT05878210
Evaluating the SUBLOCADE Treatment Exit Strategy
An observational study of Opioid Use Disorder, run by Indivior Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Nov 2023to 9 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and discontinue SUBLOCADE treatment.
Who may be able to join
- Participants must meet all of the following criteria:
- The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria:
- Has been treated with at least 12 injections of SUBLOCADE.
- In the opinion of the investigator, has had their OUD symptoms (ie, overdose, illicit/nonmedical use, withdrawal) controlled for at least 9 months.
- In the opinion of the investigator, has had any other substance use disorder (excluding alcohol, nicotine, or cannabis) symptoms controlled for at least 9 months.
- Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of SUBLOCADE.
- Has signed the ICF and is 18 years of age or older.
- Is not currently using opioids to treat a diagnosis other than OUD.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Comprehensive Addiction Medicine
Portland, Maine, 04102
About this study
Official title: A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy
The purpose of this study is to observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue MOUD.
Read the detailed description
This is a Phase IV, observational, multicentre, open-label, study in participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue MOUD treatment.
- Conditions
- Opioid Use Disorder
- Keywords
- Medicine for Opioid Use Disorder (MOUD)
- Medical subject headings
- Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful taper by the end of 6-month follow-up.
- Successful taper is defined as no consistent self-reported illicit/nonmedical opioid use and not restarting long-term MOUD treatment due to opioid withdrawal or illicit/nonmedical opioid use during follow up.
- Consistent self-reported illicit/nonmedical opioid use is defined as self-reported 4 consecutive use weeks (ie, weeks with at least 1 day of illicit/nonmedical opioid use per week) or 7 consecutive days of illicit/nonmedical opioid use.
Measured: 6 months
Secondary outcomes (6)
Key secondary - At each given month, for participants not restarting MOUD and not consistently using illicit/nonmedical opioid up to the start of that month:
Average clinical experience score (range: 0 to 4 with higher score = worse outcome) on opioid withdrawal severity during the past month
Measured: 6 months
Participants restarting MOUD (yes/no) during study follow-up
Yes/No
Measured: 6 months
Participants who reported withdrawal symptoms (yes/no) during the past month
Yes/No
Measured: 6 months
Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month
Yes/No
Measured: 6 months
Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month
Yes/No
Measured: 6 months
Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month
Yes/No
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start24 Nov 2023
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- (804) 594-4488, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878210
- Sponsor's protocol ID
- INDV-6000-407
- Status last verified
- Jan 2026
- First submitted
- 4 May 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study to Evaluate the SUBLOCADE Treatment Exit Strategy
- ClinicalTrials.gov ID
- NCT05878210
- Acronym / sponsor ID
- INDV-6000-407
- Conditions
- Opioid Use Disorder
- Keywords
- Medicine for Opioid Use Disorder (MOUD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
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 observe and assess the successful taper and opioid withdrawal experience after participants stop receiving SUBLOCADE because their healthcare provider determines their disease symptoms have been controlled for at least 9 months and they, together with their healthcare provider, plan to discontinue MOUD.
Detailed description
This is a Phase IV, observational, multicentre, open-label, study in participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have had disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and both healthcare provider and participant plan to discontinue MOUD treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a history of OUD, who have been on SUBLOCADE treatment for at least 12 injections, have disease symptoms controlled for at least 9 months in the opinion of the healthcare provider, and discontinue SUBLOCADE treatment.
Key inclusion criteria (8 listed)
- The participant, together with their healthcare provider (the investigator), have previously determined that it is appropriate to stop MOUD treatment, and the participant meets the following criteria:
- Is willing to complete the Baseline Visit 4 to 8 weeks after the last dose of SUBLOCADE.
- Has signed the ICF and is 18 years of age or older.
- Is not currently using opioids to treat a diagnosis other than OUD.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of successful taper by the end of 6-month follow-up.
Time frame: 6 months
* Successful taper is defined as no consistent self-reported illicit/nonmedical opioid use and not restarting long-term MOUD treatment due to opioid withdrawal or illicit/nonmedical opioid use during follow up. * Consistent self-reported illicit/nonmedical opioid use is defined as self-reported 4 consecutive use weeks (ie, weeks with at least 1 day of illicit/nonmedical opioid use per week) or 7 consecutive days of illicit/nonmedical opioid use.
6 secondary outcomes
Key secondary - At each given month, for participants not restarting MOUD and not consistently using illicit/nonmedical opioid up to the start of that month:
Time frame: 6 months
Participants restarting MOUD (yes/no) during study follow-up
Time frame: 6 months
Participants who reported withdrawal symptoms (yes/no) during the past month
Time frame: 6 months
Participants who used ancillary medications to treat opioid withdrawal symptoms (yes/no) during the past month
Time frame: 6 months
Participants who used rescue MOUD (yes/no) to treat opioid withdrawal symptoms during the past month
Time frame: 6 months
Participants who had self-reported illicit/nonmedical opioid use (yes/no) during the past month
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- 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.
(804) 594-4488 study director
Indivior Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Indivior Inc. 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 8 inclusion and 0 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 22 Jan 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of successful taper by the end of 6-month follow-up. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.