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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
Must not have
Cognitive impairment or psychiatric disorder requiring treatment
Positive drug screen (positive cannabis result allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one to seven days post baseline
Awards & highlights
All Individual Drugs Already Approved

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.
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.
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
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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 am receiving treatment for a cognitive impairment or psychiatric disorder.
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I have not tested positive for drugs, except for cannabis.
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I take benzodiazepines daily or have a prescription for them.
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I am currently taking naltrexone.
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I have difficulty breathing or a lung condition.
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My blood pressure is not well-controlled.
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I am experiencing ongoing pain.
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I am allergic to buprenorphine, naloxone, or baclofen.
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I am on medication for opioid addiction or prescribed opioids for a health issue.

Timeline

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

Treatment Details

Study Objectives

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
1,646 Previous Clinical Trials
2,342,758 Total Patients Enrolled
Karen L Cropsey, Psy.D.Principal InvestigatorUniversity of Alabama at Birmingham
3 Previous Clinical Trials
784 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
~0 spots leftby Dec 2024
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