SUBLOCADE Long-term Outcomes
Purpose
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
- Opioid Use Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Escondido, California 92025
Westport, Connecticut 06880
Hialeah, Florida 33012
Hollywood, Florida 33021
Miami, Florida 33126
Miami, Florida 33134
Decatur, Georgia 30033-4004
Kansas City, Kansas 66160
Prairie Village, Kansas 66210
Scarborough, Maine 04074-7163
Kristen Silvia, MD
207-883-7926
Baltimore, Maryland 21229
Dearborn Heights, Michigan 48127
Detroit, Michigan 48201
Fair Haven, Michigan 48023
Grand Rapids, Michigan 49503-4224
Tupelo, Mississippi 38801
Amherst, New York 14226
N. New Hyde Park, New York 11042
New York, New York 10029
Rockville Centre, New York 11570
Oklahoma City, Oklahoma 73112
Corvallis, Oregon 97330
Narberth, Pennsylvania 19072
Charleston, South Carolina 29407
Greenville, South Carolina 29605
Houston, Texas 77043
Clinton, Utah 84015
Richmond, Virginia 23219
More Details
- NCT ID
- NCT05860959
- Status
- Recruiting
- Sponsor
- Indivior Inc.
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.