COMPLETED

SUBLOCADE Long-term Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-31
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05860959

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Is an adult ≥ 18 years of age who has signed the informed consent form
  2. * Plans to receive additional SUBLOCADE injections and
  3. * Has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit
  4. * OR
  5. * 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
  6. * Is not currently participating in any clinical trial requiring medical intervention
  7. * Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

ATP Clinical Research
Costa Mesa, California, 92626
United States
Neighborhood Healthcare-Institute of Health
Escondido, California, 92025
United States
Elevate Health and Wellness
Westport, Connecticut, 06880
United States
United Research Institute
Hialeah, Florida, 33012
United States
Zenith Clinical Research LLC
Hollywood, Florida, 33021
United States
Jackson Health Community Center
Miami, Florida, 33126
United States
G+C Research Group
Miami, Florida, 33134
United States
Atlanta VA Medical Center
Decatur, Georgia, 30033-4004
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Collective Medical Research.
Prairie Village, Kansas, 66210
United States
Maine Health
Scarborough, Maine, 04074-7163
United States
Maryland Treatment Centers
Baltimore, Maryland, 21229
United States
Baystate Health
Springfield, Massachusetts, 01199
United States
THRYV Clinical Studies
Dearborn, Michigan, 48124
United States
Vida Clinical Studies
Dearborn Heights, Michigan, 48127
United States
Wayne State University Hospital
Detroit, Michigan, 48201
United States
North Point Medical Center
Fair Haven, Michigan, 48023
United States
SHMG Center for Integrative Medicine
Grand Rapids, Michigan, 49503-4224
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
Psych Care Consultants
St Louis, Missouri, 63141-8704
United States
DENT Neurologic Institute
Amherst, New York, 14226
United States
United Health Services
Binghamton, New York, 13903
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Core Clinical Trials
North New Hyde Park, New York, 11042
United States
Stuart Wasser Practice
Rockville Centre, New York, 11570
United States
Onsite Clinical Solutions LLC
Charlotte, North Carolina, 28277
United States
Pahl Pharmaceutical Professionals LLC
Oklahoma City, Oklahoma, 73112
United States
Healing Comfort Clinic, LLC
Corvallis, Oregon, 97330
United States
Thalia Medical Centre
Narberth, Pennsylvania, 19072
United States
Charleston Pain and Rehabilitation Center
Charleston, South Carolina, 29407
United States
Midlands Neurology
Columbia, South Carolina, 29205
United States
Prisma Health
Greenville, South Carolina, 29605
United States
Biopharma Informatic, Inc. Research Center
Houston, Texas, 77043
United States
Alpine Research Organization
Clinton, Utah, 84015
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Indivior Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-31
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Medicine for Opioid Use Disorder (MOUD)

Additional Relevant MeSH Terms

  • Opioid Use Disorder