Your session is about to expire
← Back to Search
Pharmacotherapy Strategies for Opioid Use Disorder
Study Summary
This trial will look at ways to improve treatment for people with opioid addiction, by testing different combinations of drugs and behavioral therapies. The goal is to find out which approaches are most likely to lead to long-term success and help people stay off opioids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am looking for treatment for opioid addiction and considering buprenorphine or naltrexone.You are female of childbearing potential, willing to practice an effective method of birth control for the duration of participation in the study.I want to stop my medication for opioid use disorder after talking with my doctor.I am open to being assigned to a standard treatment or a standard plus mobile health app treatment.You haven't used opioids (except buprenorphine), cocaine, methamphetamine, or non-prescribed benzodiazepines for at least 12 weeks. You don't have a current alcohol use disorder for at least 12 weeks (but it's okay if you use cannabis).I am willing to switch my buprenorphine treatment if needed.I am seeking treatment for opioid addiction and considering buprenorphine or naltrexone.I have been on buprenorphine for over a year or on XR-NTX for over 6 months for opioid use disorder.I am 18 years old or older.I am open to being assigned any form of buprenorphine treatment.I am 18 years old or older.I am willing to be assigned randomly to one of two treatment groups.I am 18 years old or older.I am open to being assigned any form of buprenorphine treatment.I am open to being assigned to a standard treatment or standard plus a health app.
- Group 1: Retention: SL-BUP standard dose + MMR
- Group 2: Retention: SL-BUP high dose + MMR
- Group 3: Discontinuation: Discontinue XR-NTX with XR-NTX + MM
- Group 4: Discontinuation: Discontinue SL-BUP with XR-BUP + MMD
- Group 5: Retention: SL-BUP standard dose + MM
- Group 6: Retention: XR-NTX + MM
- Group 7: Retention: XR-BUP + MMR
- Group 8: Retention: XR-NTX + MMR
- Group 9: Discontinuation: Discontinue SL-BUP with SL-BUP + MM
- Group 10: Discontinuation: Discontinue XR-BUP with XR-BUP + MM
- Group 11: Discontinuation: Discontinue SL-BUP with XR-BUP + MM
- Group 12: Retention: XR-BUP + MM
- Group 13: Discontinuation: Discontinue SL-BUP with SL-BUP + MMD
- Group 14: Discontinuation: Discontinue XR-BUP with XR-BUP + MMD
- Group 15: Discontinuation: Discontinue XR-NTX with XR-NTX + MMD
- Group 16: Retention: SL-BUP high dose + MM
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 18 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the use of XR-NTX pose any health risks to patients?
"XR-NTX has been evaluated and earned a safety rating of 2, as its efficacy is still being explored in Phase 2 trials."
Could you elucidate the primary functions of XR-NTX?
"XR-NTX is a medication typically used to reduce physical activity, but can also provide relief from opioid dependency, illness and ache."
Has there ever been any precedent research done with XR-NTX?
"XR-NTX was first researched in 2007 at Columbia Addiction Services and Psychotherapy Intervention Research. This drug has a total of 515 completed clinical trials on record, 94 of which are still active primarily based out Orlando, Florida."
How many health facilities are overseeing this clinical experiment?
"Patients across the country can join this study at 24 different clinical sites, such as Aspire Health Partners in Orlando, Florida; Tarzana Treatment Centers Integrated Health Care in Tarzana, California; and Gateway Community Services in Jacksonville, New hampshire."
Are there still opportunities for enrolment in this clinical research?
"As per data on clinicaltrials.gov, this study is now accepting applicants for participation. The trial was first published in June 2021 and the page was last updated in September 2022."
What is the primary aim of this investigation?
"As reported by the trial's sponsor, The Emmes Company, LLC ,the primary outcome measure to be assessed over a 24-week interval is continuous retention in MOUD treatment. Secondary outcomes that will also be observed include weekly opioid abstinence (as recorded via Timeline Followback and backed up with toxicology results), other discontinuation outcomes such as those who did not meet criteria for the primary outcome but relapsed or discontinued without relapse after restarting medication within 24 weeks of discontinuing it, and finally an assessment of patients' progress through 4 domains at week 24 using the Treatment Effectiveness Assessment (TEA)."
What is the size of this experiment's cohort?
"This study necessitates the inclusion of 2630 participants that meet predetermined criteria. These individuals may come from sites such as Aspire Health Partners in Orlando, Florida and Tarzana Treatment Centers Integrated Health Care in Tarzana, California."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- University of New Mexico Addiction and Substance Abuse Program: < 24 hours
- Mountain Manor / Maryland Treatment Centers: < 48 hours
Share this study with friends
Copy Link
Messenger