Clinical trial NCT05860959: SUBLOCADE Long-term Outcomes
Official title: A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Keywords: Medicine for Opioid Use Disorder (MOUD)
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
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
timeFrame: up to a maximum of 4 years
Secondary outcomes:
measure: 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
timeFrame: up to a maximum of 4 years
measure: Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment
timeFrame: up to a maximum of 4 years
measure: Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment
timeFrame: up to a maximum of 4 years
measure: Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment
timeFrame: up to a maximum of 4 years
measure: 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
timeFrame: up to a maximum of 4 years
measure: Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment
timeFrame: up to a maximum of 4 years
measure: The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms
timeFrame: up to a maximum of 4 years
measure: 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
timeFrame: up to a maximum of 4 years
measure: 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
timeFrame: up to a maximum of 4 years
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Escondido
country: United States
facility: Neighborhood Healthcare-Institute of Health
state: California
city: Westport
country: United States
facility: Elevate Health and Wellness
state: Connecticut
city: Hialeah
country: United States
facility: United Research Institute
state: Florida
city: Hollywood
country: United States
facility: Zenith Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: Jackson Health Community Center
state: Florida
city: Miami
country: United States
facility: G+C Research Group
state: Florida
city: Miami
country: United States
facility: Innovation Clinical 8 St. Inc.
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Clinical Trials, Inc.
state: Florida
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Prairie Village
country: United States
facility: Collective Medical Research.
state: Kansas
city: Scarborough
country: United States
facility: Maine Health
state: Maine
city: Baltimore
country: United States
facility: Maryland Treatment Centers
state: Maryland
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Dearborn
country: United States
facility: THRYV Clinical Studies
state: Michigan
city: Detroit
country: United States
facility: Wayne State University Hospital
state: Michigan
city: Fair Haven
country: United States
facility: North Point Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: SHMG Center for Integrative Medicine
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Psych Care Consultants
state: Missouri
city: Amherst
country: United States
facility: DENT Neurologic Institute
state: New York
city: Binghamton
country: United States
facility: United Health Services
state: New York
city: N. New Hyde Park
country: United States
facility: Core Clinical Trials
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rockville Centre
country: United States
facility: Stuart Wasser Practice
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Pahl Pharmaceutical Professionals LLC
state: Oklahoma
city: Sulphur
country: United States
facility: VAST Clinical Research
state: Oklahoma
city: Corvallis
country: United States
facility: Healing Comfort Clinic, LLC
state: Oregon
city: Narberth
country: United States
facility: Thalia Medical Centre
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Pain and Rehabilitation Center
state: South Carolina
city: Columbia
country: United States
facility: Midlands Neurology
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Houston
country: United States
facility: Biopharma Informatic, Inc. Research Center
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Melbourne
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Stepney
country: Australia
facility: Drug and Alcohol Services South Australia (DASSA)
state: South Australia
city: Richmond
country: Australia
facility: Turning Point
city: Calgary
country: Canada
facility: Smart Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Recovery Alberta
state: Alberta
city: Surrey
country: Canada
facility: Fraser Health Authority
state: British Columbia
city: Burlington
country: Canada
facility: Dr. J.S. Dhillon Medicine Prof. Corp
state: Ontario
city: Edmonton
country: Canada
facility: Savera Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: The Stipley Clinic
state: Ontario
city: Owen Sound
country: Canada
facility: Brightshores Health System
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Rapid Assessment Addiction Medicine Clinic
state: Ontario
city: Toronto
country: Canada
facility: Comprehensive Treatment Clinic
state: Ontario
city: Linköping
country: Sweden
facility: Linkoping University Hospital, Psychiatry Center
city: Stockholm
country: Sweden
facility: Beroendecentrum
Study officials:
References: