SUBLOCADE Long-term Outcomes

Description

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.

Conditions

Opioid Use Disorder

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Study Overview

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Study Details

Study overview

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.

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

SUBLOCADE Long-term Outcomes

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Costa Mesa

ATP Clinical Research, Costa Mesa, California, United States, 92626

Escondido

Neighborhood Healthcare-Institute of Health, Escondido, California, United States, 92025

Westport

Elevate Health and Wellness, Westport, Connecticut, United States, 06880

Hialeah

United Research Institute, Hialeah, Florida, United States, 33012

Hollywood

Zenith Clinical Research LLC, Hollywood, Florida, United States, 33021

Miami

Jackson Health Community Center, Miami, Florida, United States, 33126

Miami

G+C Research Group, Miami, Florida, United States, 33134

Miami

Innovation Clinical 8 St. Inc., Miami, Florida, United States, 33144

Palmetto Bay

Innovation Clinical Trials, Inc., Palmetto Bay, Florida, United States, 33157

Decatur

Atlanta VA Medical Center, Decatur, Georgia, United States, 30033-4004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indivior Inc.,

Study Record Dates

2027-08