Opioid Use DisorderNCT05860959
SUBLOCADE Long-term Outcomes
An observational study of Opioid Use Disorder, run by Indivior Inc. at 49 sites in 4 countries.
Trial summary
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. 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
- 480 participants
- Where
- 49 sitesin 4 countries
- Study dates
- 31 Aug 2023to 31 Aug 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 may enroll if they have initiated treatment with SUBLOCADE within 3 months prior to signing the informed consent form (ICF), or have completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and received their last dose of SUBLOCADE on the study within 3 months prior to signing the ICF, and plan to receive additional SUBLOCADE injections.
Who may be able to join
- Participants must meet all of the following criteria:
- Is an adult ≥ 18 years of age who has signed the informed consent form
- Plans to receive additional SUBLOCADE injections and
- Has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit
- OR
- Has completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and has received the last dose of SUBLOCADE on that study within 3 months prior to Baseline Visit
- Is not currently participating in any clinical trial requiring medical intervention
- Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence
Who cannot join
None listed.
Trial locations and contacts
49 sites in 4 countries.
49 sites in 4 countries
United States35 sites
DENT Neurologic Institute
Amherst, New York, 14226
Maryland Treatment Centers
Baltimore, Maryland, 21229
United Health Services
Binghamton, New York, 13903
Charleston Pain and Rehabilitation Center
Charleston, South Carolina, 29407
Onsite Clinical Solutions LLC
Charlotte, North Carolina, 28277
Alpine Research Organization
Clinton, Utah, 84015
Midlands Neurology
Columbia, South Carolina, 29205
Healing Comfort Clinic, LLC
Corvallis, Oregon, 97330
ATP Clinical Research
Costa Mesa, California, 92626
THRYV Clinical Studies
Dearborn, Michigan, 48124
Vida Clinical Studies
Dearborn Heights, Michigan, 48127
Atlanta VA Medical Center
Decatur, Georgia, 30033-4004
Wayne State University Hospital
Detroit, Michigan, 48201
Neighborhood Healthcare-Institute of Health
Escondido, California, 92025
North Point Medical Center
Fair Haven, Michigan, 48023
SHMG Center for Integrative Medicine
Grand Rapids, Michigan, 49503-4224
Prisma Health
Greenville, South Carolina, 29605
United Research Institute
Hialeah, Florida, 33012
Zenith Clinical Research LLC
Hollywood, Florida, 33021
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77043
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jackson Health Community Center
Miami, Florida, 33126
G+C Research Group
Miami, Florida, 33134
Thalia Medical Centre
Narberth, Pennsylvania, 19072
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Core Clinical Trials
North New Hyde Park, New York, 11042
Pahl Pharmaceutical Professionals LLC
Oklahoma City, Oklahoma, 73112
Collective Medical Research.
Prairie Village, Kansas, 66210
Virginia Commonwealth University
Richmond, Virginia, 23219
Stuart Wasser Practice
Rockville Centre, New York, 11570
Maine Health
Scarborough, Maine, 04074-7163
Baystate Health
Springfield, Massachusetts, 01199
Psych Care Consultants
St Louis, Missouri, 63141-8704
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Elevate Health and Wellness
Westport, Connecticut, 06880
Canada8 sites
Dr. J.S. Dhillon Medicine Prof. Corp
Burlington, Ontario, L7M 4X9
Smart Clinic
Calgary, Alberta, T2E2R2
Recovery Alberta
Edmonton, Alberta, T5J 3E4
The Stipley Clinic
Hamilton, Ontario, L8N 1H3
Brightshores Health System
Owen Sound, Ontario, N4K 6M9
Bluewater Rapid Assessment Addiction Medicine Clinic
Sarnia, Ontario, N7T 5W9
Fraser Health Authority
Surrey, British Columbia, V3T 0H1
Comprehensive Treatment Clinic
Toronto, Ontario, M4J 1M3
Australia4 sites
St Vincent's Hospital Melbourne
Fitzroy, Melbourne, 3065
John Hunter Hospital
Newcastle, New South Wales, 2300
Turning Point
Richmond, VIC 3121
Drug and Alcohol Services South Australia (DASSA)
Stepney, South Australia, 5069
Sweden2 sites
Linkoping University Hospital, Psychiatry Center
Linköping, 58185
Beroendecentrum
Stockholm, SE-11365
About this study
Official title: A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years.
Read the detailed description
This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.
- 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.
Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline
- Definition of early remission: None of the criteria for OUD has been met for at least 3 months but for less than 12 months with the exception that Criterion 4 ("Craving, or a strong desire or urge to use opioids,") may be met.
- Definition of sustained remission: None of the criteria for OUD has been met for at least 12 months with the exception that Criterion 4 ("Craving, or a strong desire or urge to use opioids,") may be met.
Measured: up to a maximum of 4 years
Secondary outcomes (9)
Key Secondary: Participants with "no symptoms" or improving by ≥1 DSM-5 severity classification within the last 3 months (moderate to mild, or severe to mild or moderate) relative to study Baseline (yes/no) at Month 6 and Years 1, 2, and 3
DSM-5-Related
Measured: up to a maximum of 4 years
Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment
DSM-5-Related
Measured: up to a maximum of 4 years
Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment
DSM-5-Related
Measured: up to a maximum of 4 years
Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment
DSM-5-Related
Measured: up to a maximum of 4 years
Time to discontinuing initial SUBLOCADE treatment and the corresponding reasons for discontinuation, eg, resolution of OUD symptoms, safety concerns, treatment failure, or seeking alternative MOUD treatment
MOUD Use and Retention
Measured: up to a maximum of 4 years
Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment
MOUD Use and Retention
Measured: up to a maximum of 4 years
The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms
MOUD Use and Retention
Measured: up to a maximum of 4 years
Participants with any positive opioid use in the past month (yes/no) at Month 6 and Years 1, 2, and 3 while on initial SUBLOCADE treatment
Illicit Opioid Use (Self-Reports)
Measured: up to a maximum of 4 years
Participants with opioid overdose requiring intervention (yes/no) while on initial SUBLOCADE treatment at least once during the first 6 months, and during Years 1, 2, and 3
Opioid Overdose Requiring Intervention
Measured: up to a maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start31 Aug 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860959
- Sponsor's protocol ID
- INDV-6000-406
- Status last verified
- Dec 2024
- First submitted
- 5 May 2023
- Last updated
- 16 Oct 2025
- 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 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)
- ClinicalTrials.gov ID
- NCT05860959
- Acronym / sponsor ID
- INDV-6000-406
- Conditions
- Opioid Use Disorder
- Keywords
- Medicine for Opioid Use Disorder (MOUD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 16 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.
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years.
Detailed description
This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.
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 may enroll if they have initiated treatment with SUBLOCADE within 3 months prior to signing the informed consent form (ICF), or have completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and received their last dose of SUBLOCADE on the study within 3 months prior to signing the ICF, and plan to receive additional SUBLOCADE injections.
Key inclusion criteria (8 listed)
- Is an adult ≥ 18 years of age who has signed the informed consent form
- Plans to receive additional SUBLOCADE injections and
- Is not currently participating in any clinical trial requiring medical intervention
- Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence
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
Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline
Time frame: up to a maximum of 4 years
* Definition of early remission: None of the criteria for OUD has been met for at least 3 months but for less than 12 months with the exception that Criterion 4 ("Craving, or a strong desire or urge to use opioids,") may be met. * Definition of sustained remission: None of the criteria for OUD has been met for at least 12 months with the exception that Criterion 4 ("Craving, or a strong desire or urge to use opioids,") may be met.
9 secondary outcomes
Key Secondary: Participants with "no symptoms" or improving by ≥1 DSM-5 severity classification within the last 3 months (moderate to mild, or severe to mild or moderate) relative to study Baseline (yes/no) at Month 6 and Years 1, 2, and 3
Time frame: up to a maximum of 4 years
Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment
Time frame: up to a maximum of 4 years
Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment
Time frame: up to a maximum of 4 years
Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment
Time frame: up to a maximum of 4 years
Time to discontinuing initial SUBLOCADE treatment and the corresponding reasons for discontinuation, eg, resolution of OUD symptoms, safety concerns, treatment failure, or seeking alternative MOUD treatment
Time frame: up to a maximum of 4 years
Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment
Time frame: up to a maximum of 4 years
The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms
Time frame: up to a maximum of 4 years
Participants with any positive opioid use in the past month (yes/no) at Month 6 and Years 1, 2, and 3 while on initial SUBLOCADE treatment
Time frame: up to a maximum of 4 years
Participants with opioid overdose requiring intervention (yes/no) while on initial SUBLOCADE treatment at least once during the first 6 months, and during Years 1, 2, and 3
Time frame: up to a maximum of 4 years
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 16 Oct 2025.
- 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.
49 sites in 4 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 49 sites in 4 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada, Australia, Sweden. 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?
Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline (time frame: up to a maximum of 4 years). 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 16 Oct 2025.