Clinical Trial

A 4-year Longitudinal Clinical Study for SUBLOCADE® injections with Adults with Opioid Use Disorder/Opioid Dependence

Protocol Number: INDV-6000-406

Principal Investigator

Dr. Mohamed Elsamra, MD

Medical Director and Psychiatrist

Rukiya Symister, MA, LMFTA, PhD Candidate

Clinical Psychology Doctoral Student Intern, Study Coordinator

Contact Us

For more information about this study, including how to become a study participant, contact:

Rukiya Symister rsymister@elevatehealthandwellnessct.com

Trial Purpose and Description:

This is a 4-year, longitudinal, observational study of participants with Opioid Use Disorder (OUD)/Opioid Dependence. The purpose of this study is to assess the clinical outcomes of long-term treatment with SUBLOCADE® and observe enduring changes in lifestyle, health, and social factors that are part of the recovery process. Abstinence/opioid misuse as well as participants’ physical, psychological, social, and economic well-being will therefore be monitored on a long-term basis to better understand factors associated with recovery from OUD.

Study Population:

Adults with Opioid Use Disorder/Opioid Dependence

Eligibility Criteria:

Adults (18 years and older) who plan to receive SUBLOCADE® injections and are not currently on SUBLOCADE® injections.
Has initiated treatment for OUD/Opioid Dependence with SUBLOCADE® within the last
3 months before the Baseline Visit.
OR
Has completed an Indivior SUBLOCADE® study (e.g., INDV-6000-401, INDV-6000-405) and has received the last dose of SUBLOCADE® in that study within 3 months before the Baseline Visit.
Meets the criteria of the DSM-5 for Opioid Use Disorder/ Opioid Dependence:

Opioids are often taken in larger amounts or over a longer period than intended.
There is a persistent desire or unsuccessful efforts to cut down or control opioid use.
Craving or a strong desire to use opioids.

Exclusion Criteria:

Inability to provide written informed consent to participate in the study.
Participant is in a clinical trial at the time of enrollment that requires medical intervention.
Participant is not currently using opioids to treat a diagnosis other than OUD/opioid dependence.

Compensation available for participation!