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Opioid Partial Agonist

Buprenorphine for Opioid Use Disorder

Phase 2
Recruiting
Led By Gail D'Onofrio, MD, MS
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post randomization
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I need ongoing opioid medication for my pain.
Select...
I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization
Secondary outcome measures
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 outcome measures
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
14%
Headache
14%
Constipation
9%
Injection Site Pain
9%
Injection Site Erythema
5%
Injection Site Pruritus
5%
Dermatitis Contac
5%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
CAM2038 q1w, 24 mg
CAM2038 q1w, 32 mg

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
2,468 Previous Clinical Trials
2,617,348 Total Patients Enrolled
University of PennsylvaniaOTHER
2,002 Previous Clinical Trials
42,878,999 Total Patients Enrolled
NYU Langone HealthOTHER
1,368 Previous Clinical Trials
837,726 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

Frequently Asked Questions

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

How many candidates is the clinical trial recruiting?

"Affirmative. According to the clinicaltrials.gov website, this experiment is still recruiting participants and was initially made available on July 8th 2020. This extensive trial requires 2000 people from 17 medical centers in total."

Answered by AI

Are there any openings in this clinical experiment for interested participants?

"Affirmative, the information on clinicaltrials.gov verifies this trial's active recruitment status. It was initially made available to potential enrollees on July 8th 2020 and its details were most recently revised on October 6th 2022."

Answered by AI

Has CAM2038 been utilized by researchers in the past to conduct any other experiments?

"In 2012, CAM2038 was first tested at Shalvata Medical Health Center. To date, 198 studies have been finished and 40 are presently underway in various locations including Portland, Maine."

Answered by AI

What is the ultimate aim of this trial?

"According to the Emmes Company, LLC (the clinical trial sponsor), this experiment's primary objective is gauging patient engagement in formal addiction treatment over a 30-day post randomization timeline. Secondary objectives include assessing Clinical Opiate Withdrawal Scale scores and changes in number of Data 2000 X-waivered ED prescribers over 6 months' time. Additionally, COWS readings at the index visit will be monitored for moderate opioid withdrawal symptoms."

Answered by AI

Are there numerous localities in which this clinical trial is being conducted?

"Currently, 17 different trial sites are operational. These include centres in Portland, Oakland and Tampa; with additional locations available across the country. It is advisable to select a nearby site to reduce any potential travel costs associated with participation."

Answered by AI

Is CAM2038 a viable option for patient care with minimal adverse effects?

"CAM2038's safety has been confirmed by preliminary research, so it earned a score of 2. The Phase 2 trial also did not determine the efficacy of this medication yet."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Other
Georgia
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Grady Memorial Hospital
Temple University Hospital - Episcopal Campus
Medical University of South Carolina
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

Have tried so many types of treatment and failed.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Emergency Department-Initiated Buprenorphine Validation Network Trial
2020. "Emergency Department-Initiated Buprenorphine Validation Network Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04225598.
All > Opioid Dependence > Probuphine
~125 spots leftby Jul 2024
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