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Partial Agonist

Pharmacotherapy Strategies for Opioid Use Disorder

Phase 2
Recruiting
Led By Edward V Nunes, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older;
Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or extended-release injection naltrexone (XR-NTX);
Timeline
Screening 1 day
Treatment 18 months
Follow Up 6 months
Awards & highlights

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.

Who is the study for?
Adults with opioid use disorder seeking treatment can join this study. They must be in stable health, speak English, and women should use birth control if applicable. Excluded are those with severe medical or mental conditions, certain substance dependencies, legal constraints that prevent participation, or who have used specific mHealth apps recently.Check my eligibility
What is being tested?
The trial is testing combinations of medications like buprenorphine (BUP) and extended-release naltrexone (XR-NTX), along with behavioral strategies to improve retention in treatment for opioid addiction and to determine safe discontinuation methods for long-term success without relapse.See study design
What are the potential side effects?
Possible side effects include reactions related to the medications such as nausea, headaches, dizziness, potential liver damage from naltrexone; buprenorphine may cause respiratory issues or dependency. Behavioral interventions might lead to emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am seeking treatment for opioid addiction and considering buprenorphine or naltrexone.
Select...
I am 18 years old or older.
Select...
I am looking for treatment for opioid addiction and considering buprenorphine or naltrexone.

Timeline

Screening ~ 1 day
Treatment ~ 18 months
Follow Up ~6 months
This trial's timeline: 1 day for screening, 18 months for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Discontinuation: Completed Discontinuation without Relapse
Retention: Continuous retention in MOUD treatment at 26 weeks
Secondary outcome measures
DSK2: Treatment effectiveness
Discontinuation KS1: Other discontinuation outcomes
Retention KS1: Weekly opioid abstinence
+1 more
Other outcome measures
D-Other 10: Sexual risk
D-Other 11: Rate of incarceration
D-Other 12: Rate of homelessness
+31 more

Trial Design

16Treatment groups
Experimental Treatment
Group I: Retention: XR-NTX + MMRExperimental Treatment2 Interventions
Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group II: Retention: XR-NTX + MMExperimental Treatment2 Interventions
Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group III: Retention: XR-BUP + MMRExperimental Treatment2 Interventions
Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group IV: Retention: XR-BUP + MMExperimental Treatment2 Interventions
Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group V: Retention: SL-BUP standard dose + MMRExperimental Treatment2 Interventions
Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component.
Group VI: Retention: SL-BUP standard dose + MMExperimental Treatment2 Interventions
Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group VII: Retention: SL-BUP high dose + MMRExperimental Treatment2 Interventions
High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group VIII: Retention: SL-BUP high dose + MMExperimental Treatment2 Interventions
High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group IX: Discontinuation: Discontinue XR-NTX with XR-NTX + MMDExperimental Treatment2 Interventions
Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group X: Discontinuation: Discontinue XR-NTX with XR-NTX + MMExperimental Treatment2 Interventions
Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group XI: Discontinuation: Discontinue XR-BUP with XR-BUP + MMDExperimental Treatment2 Interventions
Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group XII: Discontinuation: Discontinue XR-BUP with XR-BUP + MMExperimental Treatment2 Interventions
Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group XIII: Discontinuation: Discontinue SL-BUP with XR-BUP + MMDExperimental Treatment2 Interventions
Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group XIV: Discontinuation: Discontinue SL-BUP with XR-BUP + MMExperimental Treatment2 Interventions
Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Group XV: Discontinuation: Discontinue SL-BUP with SL-BUP + MMDExperimental Treatment2 Interventions
Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Group XVI: Discontinuation: Discontinue SL-BUP with SL-BUP + MMExperimental Treatment2 Interventions
Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MM
2017
N/A
~500
MMR
2006
Completed Phase 3
~2250
XR-NTX
2015
Completed Phase 3
~460

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
837,536 Total Patients Enrolled
New York State Psychiatric InstituteOTHER
475 Previous Clinical Trials
151,717 Total Patients Enrolled
Columbia UniversityOTHER
1,432 Previous Clinical Trials
2,458,783 Total Patients Enrolled

Media Library

SL-BUP (Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04464980 — Phase 2
Opioid Use Disorder Research Study Groups: Retention: SL-BUP standard dose + MMR, Retention: SL-BUP high dose + MMR, Discontinuation: Discontinue XR-NTX with XR-NTX + MM, Discontinuation: Discontinue SL-BUP with XR-BUP + MMD, Retention: SL-BUP standard dose + MM, Retention: XR-NTX + MM, Retention: XR-BUP + MMR, Retention: XR-NTX + MMR, Discontinuation: Discontinue SL-BUP with SL-BUP + MM, Discontinuation: Discontinue XR-BUP with XR-BUP + MM, Discontinuation: Discontinue SL-BUP with XR-BUP + MM, Retention: XR-BUP + MM, Discontinuation: Discontinue SL-BUP with SL-BUP + MMD, Discontinuation: Discontinue XR-BUP with XR-BUP + MMD, Discontinuation: Discontinue XR-NTX with XR-NTX + MMD, Retention: SL-BUP high dose + MM
Opioid Use Disorder Clinical Trial 2023: SL-BUP Highlights & Side Effects. Trial Name: NCT04464980 — Phase 2
SL-BUP (Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04464980 — Phase 2
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04464980 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Pennsylvania
New York
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of New Mexico Addiction and Substance Abuse Program
Shoreline Behavioral Health Services
Bellevue Hospital Center
Other
How many prior treatments have patients received?
3+
0
1

What questions have other patients asked about this trial?

Can you be on methadone? How long is the study? How will I be compensated? Is it long term?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I have never been in a study before I feel I would learn a lot from it. i just think it may really benefit me in staying clean and off of drugs.
PatientReceived 1 prior treatment
I’m on methadone and I’ve tried Suboxone in the past. I still feel like using.
PatientReceived 2+ prior treatments
I'm tired of being hooked on a drug that not only consumes you, but your finances as well, please consider me for this new medication and a chance at a normal life without being on drugs.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. University of New Mexico Addiction and Substance Abuse Program: < 24 hours
  2. Mountain Manor / Maryland Treatment Centers: < 48 hours
~949 spots leftby Jul 2026