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Buprenorphine + Baclofen for Acute Pain

Phase 2 & 3
Waitlist Available
Led By Karen L Cropsey, Psy.D.
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one to seven days post baseline
Awards & highlights

Study Summary

This trial will test whether the drug baclofen can make the pain-relieving effects of buprenorphine stronger in healthy people with acute pain.

Who is the study for?
This trial is for healthy adults who speak English and do not have a history of opioid or substance use disorders (except nicotine), no known allergies to buprenorphine, naloxone, or baclofen, no pain conditions, uncontrolled high blood pressure, breathing issues, benzodiazepine prescriptions or daily use. They must not be on naltrexone treatment, pregnant/nursing women are excluded as well.Check my eligibility
What is being tested?
The study is testing whether adding baclofen at two different doses (5 mg and 10 mg) can improve the pain relief provided by buprenorphine in people experiencing acute pain. Some participants will receive a placebo instead of baclofen to compare effects.See study design
What are the potential side effects?
Possible side effects may include drowsiness, weakness, fatigue from buprenorphine; and muscle relaxation effects like dizziness or nausea from baclofen. Placebos typically have no active ingredients but can cause perceived side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through one week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through one week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Conditioned pain modulation
Pain Threshold
Pain tolerance
+2 more
Secondary outcome measures
26-item Visual Analog Scale ("Subjective drug effects")
26-item Visual Analog Scale (VAS)
Drug Effects Questionnaire-5
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Baclofen 5mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive 5 mg of Baclofen.
Group II: Baclofen 10mgExperimental Treatment1 Intervention
Participants randomized to this arm will receive 10 mg of Baclofen.
Group III: PlaceboPlacebo Group1 Intervention
Participants randomized to this arm will receive Placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baclofen 10mg
2013
N/A
~10

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,014 Total Patients Enrolled
Karen L Cropsey, Psy.D.Principal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
734 Total Patients Enrolled

Media Library

Buprenorphine Plus Baclofen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04251819 — Phase 2 & 3
Pain relief Research Study Groups: Baclofen 5mg, Baclofen 10mg, Placebo
Pain relief Clinical Trial 2023: Buprenorphine Plus Baclofen Highlights & Side Effects. Trial Name: NCT04251819 — Phase 2 & 3
Buprenorphine Plus Baclofen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04251819 — Phase 2 & 3
Pain relief Patient Testimony for trial: Trial Name: NCT04251819 — Phase 2 & 3

Frequently Asked Questions

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

What goals is this research looking to achieve?

"This study's primary goal is to measure pain tolerance over a one-week period. Secondary outcomes that will be used to evaluate the success of the intervention include the Opioid Symptom Checklist (a list of true/false questions measuring opioid effects), the McGill Pain Questionnaire-Short Form (15 descriptors [11 sensory; 4 affective] rated on a scale of 0-3 in terms of intensity), and the Drug Effects Questionnaire-5 (which assesses drug effects using VAS ratings from "not at all" to "very much")."

Answered by AI

What conditions or symptoms is Baclofen 5 MG commonly prescribed for?

"The recommended dosage of Baclofen 5 MG is most commonly used to mitigate pain, however it can also be useful in treating conditions like multiple sclerosis, myalgia, and spinal cord injuries."

Answered by AI

Are there any other clinical trials that have tested Baclofen 5 MG?

"There are currently 4 clinical trials underway for Baclofen 5 MG. 3 of those studies have reached Phase 3. 88 different locations around the world are conducting research on this medication, with a large number of those based in Birmingham, Alabama."

Answered by AI

Is this research currently looking for more participants?

"That is correct, the clinical trial is looking for patients as of right now. The first posting was on 1/21/2021, and the last update was on 5/26/2022. They are enrolling 60 participants total at just 1 location."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Alabama, Birmingham
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Currently taking Celebrex and its not working so good anymore to help with pain that is more often severe.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers
Karen Cropsey 2021. "Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04251819.
All > Acute Pain
~2 spots leftby Dec 2024
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