SUBLOCADE Long-term Outcomes

Opioid Use Disorder Clinical Trial

Official title:

A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05860959
• Other study ID #: INDV-6000-406
• Status: Recruiting
• Start date: August 31, 2023
• Est. completion date: August 2027

Study information

• Verified date: May 2024
• Source: Indivior Inc.
• Contact: Global Director Clinical Development
• Phone: (804) 594-4488
• Email: trialdisclosure[@]indivior.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Locations

Country	Name	City	State
Canada	The Smart Clinic	Calgary	Alberta
Canada	Savera Medical Centre	Edmonton	Ontario
Canada	The Hamilton Clinic	Hamilton	Ontario
Canada	Bluewater Rapid Assessment Addiction Medicine Clinic	Sarnia	Ontario
Canada	Comprehensive Treatment Clinic	Toronto	Ontario
United States	DENT Neurologic Institute	Amherst	New York
United States	Maryland Treatment Centers	Baltimore	Maryland
United States	Onsite Clinical Solutions LLC	Charlotte	North Carolina
United States	Alpine Research Organization	Clinton	Utah
United States	Midlands Neurology	Columbia	South Carolina
United States	THRYV Clinical Studies	Dearborn	Michigan
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Neighborhood Healthcare-Institute of Health	Escondido	California
United States	North Point Medical Center	Fair Haven	Michigan
United States	Corewell Health Medical Group West	Grand Rapids	Michigan
United States	Prisma Health	Greenville	South Carolina
United States	G+C Research Group	Miami	Florida
United States	Innovation Clinical 8 St. Inc.	Miami	Florida
United States	Jackson Health Community Center	Miami	Florida
United States	Thalia Medical Centre	Narberth	Pennsylvania
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Pahl Pharmaceutical Professionals LLC	Oklahoma City	Oklahoma
United States	Innovation Clinical Trials, Inc.	Palmetto Bay	Florida
United States	Collective Medical Research.	Prairie Village	Kansas
United States	Stuart Wasser Practice	Rockville Centre	New York
United States	Psych Care Consultants	Saint Louis	Missouri
United States	Maine Health	Scarborough	Maine
United States	Baystate Health	Springfield	Massachusetts
United States	VAST Clinical Research	Sulphur	Oklahoma
United States	Elevate Health and Wellness	Westport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to a maximum of 4 years
Secondary	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	up to a maximum of 4 years
Secondary	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	up to a maximum of 4 years
Secondary	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	up to a maximum of 4 years
Secondary	Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment	DSM-5-Related	up to a maximum of 4 years
Secondary	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	up to a maximum of 4 years
Secondary	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	up to a maximum of 4 years
Secondary	The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms	MOUD Use and Retention	up to a maximum of 4 years
Secondary	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)	up to a maximum of 4 years
Secondary	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	up to a maximum of 4 years