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
Kansas City, Kansas 66160
More Details
- 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.