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Opioid Partial Agonist

Buprenorphine for Opioid Use Disorder

Phase 2
Waitlist Available
Led By David Fiellin, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Require continued prescription opioids for a pain condition
Be 18 years or older
Must not have
Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains < 8 during ED stay
Have a medical or psychiatric condition that requires hospitalization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post randomization
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will recruit patients with opioid use disorder who present to the emergency department, and compare the effectiveness of two different medication treatments for engaging them in formal addiction treatment 7 days later.

Who is the study for?
Adults who visit the emergency department (ED) with moderate to severe opioid use disorder, not currently on medication-assisted treatment, and have a certain level of withdrawal symptoms are eligible. They must speak English or Spanish at sites with translated materials, provide contact information for follow-up, and consent to study procedures.
What is being tested?
The trial is testing two forms of buprenorphine: sublingual (under the tongue) versus extended-release (long-acting injection), to see which is more effective in engaging patients in addiction treatment one week after an ED visit. It includes training EDs across the U.S., randomizing participants into groups, and validating electronic health record data.
What are the potential side effects?
Buprenorphine can cause side effects like nausea, vomiting, constipation, muscle aches or cramps, cravings for opioids, difficulty sleeping (insomnia), irritability or mood swings. Some people might also experience injection site reactions with the long-acting form.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need ongoing opioid medication for my pain.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was given opioids (not BUP) in the ED and my withdrawal symptoms were mild.
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I have a health or mental condition that needed hospital care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization
Secondary study objectives
Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration
Ancillary Component: Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration
Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration
+9 more
Other study objectives
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Abstinent Years
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): Engagement
RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP using ICER (incremental cost-effectiveness ratio): QALYs

Side effects data

From 2016 Phase 2 trial • 47 Patients • NCT02611752
24%
Constipation
12%
Nausea
12%
Injection Site Pain
8%
Injection Site Pruritus
8%
Injection site Haemorrhage
8%
Dermatitis Contac
8%
Acne
8%
Ventricular Tachycardia
8%
Faeces Hard
8%
Injection Site Erythema
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
CAM2038 q1w, 32 mg
CAM2038 q1w, 24 mg

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: XR-BUPExperimental Treatment1 Intervention
Injectable buprenorphine
Group II: Standard SL-BUPActive Control1 Intervention
Sublingual buprenorphine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAM2038
2015
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,606 Previous Clinical Trials
3,327,869 Total Patients Enrolled
University of PennsylvaniaOTHER
2,084 Previous Clinical Trials
42,725,048 Total Patients Enrolled
NYU Langone HealthOTHER
1,415 Previous Clinical Trials
854,203 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
913 Previous Clinical Trials
570,801 Total Patients Enrolled
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,031,458 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
204 Previous Clinical Trials
1,314,685 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,050,138 Total Patients Enrolled
National Drug Abuse Treatment Clinical Trials NetworkNETWORK
6 Previous Clinical Trials
972 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,091 Previous Clinical Trials
1,152,746 Total Patients Enrolled
Alameda Health SystemOTHER
6 Previous Clinical Trials
1,326 Total Patients Enrolled

Media Library

Buprenorphine Sublingual Product (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04225598 — Phase 2
Opioid Use Disorder Research Study Groups: XR-BUP, Standard SL-BUP
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Sublingual Product Highlights & Side Effects. Trial Name: NCT04225598 — Phase 2
Buprenorphine Sublingual Product (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225598 — Phase 2
~369 spots leftby Dec 2025
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