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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 belowSelect...
I need ongoing opioid medication for my pain.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post randomization
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 moreOther 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 • NCT0261175214%
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
2,485 Previous Clinical Trials
2,620,380 Total Patients Enrolled
University of PennsylvaniaOTHER
2,015 Previous Clinical Trials
42,872,026 Total Patients Enrolled
NYU Langone HealthOTHER
1,373 Previous Clinical Trials
839,120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was given opioids (not BUP) in the ED and my withdrawal symptoms were mild.I tested positive for opioids, but not just fentanyl, and meet the criteria for moderate to severe opioid use disorder.I am willing to follow all study procedures and attend follow-up assessments.You have a significant addiction to opioids that has been diagnosed using specific criteria.You have been diagnosed with moderate to severe opioid use disorder (OUD) according to the DSM-5 guidelines.You are currently experiencing severe mental health issues that prevent you from understanding and consenting to the study.I need ongoing opioid medication for my pain.I am 18 years old or older.Your level of opioid withdrawal, as measured by the Clinical Opiate Withdrawal Scale (COWS), is less than 8.I am willing to follow all study procedures and daily assessments.I have a health or mental condition that needed hospital care.
Research Study Groups:
This trial has the following groups:- Group 1: XR-BUP
- Group 2: Standard SL-BUP
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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