SUBLOCADE Long-term Outcomes

Sponsor

Indivior Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05860959

Collaborator

(none)

1,200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder

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

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2027

Anticipated Study Completion Date :

Jul 1, 2027

Outcome Measures

Primary Outcome Measures

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 [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.

Secondary Outcome Measures

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 [up to a maximum of 4 years]
DSM-5-Related
Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment [up to a maximum of 4 years]
DSM-5-Related
Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment [up to a maximum of 4 years]
DSM-5-Related
Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment [up to a maximum of 4 years]
DSM-5-Related
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 [up to a maximum of 4 years]
MOUD Use and Retention
Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment [up to a maximum of 4 years]
MOUD Use and Retention
The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms [up to a maximum of 4 years]
MOUD Use and Retention
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 [up to a maximum of 4 years]
Illicit Opioid Use (Self-Reports)
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 [up to a maximum of 4 years]
Opioid Overdose Requiring Intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Indivior Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Indivior Inc.

ClinicalTrials.gov Identifier:

NCT05860959

Other Study ID Numbers:

INDV-6000-406

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Indivior Inc.

Medicine for Opioid Use Disorder (MOUD)

Additional relevant MeSH terms:

Opioid-Related Disorders

Substance-Related Disorders

Study Results

No Results Posted as of May 16, 2023