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Opioid

Buccal Buprenorphine vs. Oxycodone for Pain

Phase 4
Recruiting
Led By Daniel Larach, MD, MSTR, MA
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intact cognitive status and ability to provide informed consent
Age 18-65
Must not have
Liver/kidney disease
Seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 3.5 hours after study drug administration on each medication condition
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial compares the abuse potential of low-dose buprenorphine to oxycodone in healthy participants across 5 sessions. Quantitative Sensory Testing will measure pain responsiveness & drug liking to determine abuse potential.

Who is the study for?
This trial is for healthy adults aged 18-65 who can consent and have not used opioids in the last three months. It's not for those with severe mental health issues, substance use disorders, chronic pain, liver/kidney disease, seizure disorders, or recent drug use that could affect the study.
What is being tested?
The study tests if low-dose buccal buprenorphine (placed between cheek and gum) has less potential for abuse compared to oral oxycodone while still providing pain relief. Participants will try different doses of buprenorphine, a placebo, and oxycodone in separate sessions.
What are the potential side effects?
Buprenorphine may cause nausea, dizziness, sweating or constipation. Oxycodone can lead to similar effects plus risk of addiction. Placebos typically have no active ingredients but can sometimes 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 mentally capable of understanding and agreeing to the trial.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have liver or kidney disease.
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I have a seizure disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 3.5 hours after study drug administration on each medication condition
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3.5 hours after study drug administration on each medication condition for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale (VAS) between oxycodone 10 mg and an equianalgesic dose of buprenorphine
Quantitative sensory testing (QST) thermal pain tolerance in seconds
Secondary study objectives
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions
McGill Pain Questionnaire - Short Form
+11 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Buccal Buprenorphine 900mcg and oral PlaceboExperimental Treatment2 Interventions
In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.
Group II: Buccal Buprenorphine 600mcg and oral PlaceboExperimental Treatment2 Interventions
In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.
Group III: Buccal Buprenorphine 450mcg and oral PlaceboExperimental Treatment2 Interventions
In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.
Group IV: Buccal Buprenorphine 300mcg and oral PlaceboExperimental Treatment2 Interventions
In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.
Group V: Oral immediate release oxycodone 10mg and buccal placeboActive Control2 Interventions
In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.
Group VI: Oral placebo and buccal placeboPlacebo Group2 Interventions
In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Placebo
2017
Completed Phase 4
~4590

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,428 Total Patients Enrolled
25 Trials studying Pain
3,207 Patients Enrolled for Pain
Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,381 Total Patients Enrolled
6 Trials studying Pain
532 Patients Enrolled for Pain
Daniel Larach, MD, MSTR, MAPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
465 Total Patients Enrolled

Media Library

Buccal Buprenorphine (Opioid) Clinical Trial Eligibility Overview. Trial Name: NCT05988710 — Phase 4
Pain Research Study Groups: Buccal Buprenorphine 900mcg and oral Placebo, Buccal Buprenorphine 450mcg and oral Placebo, Buccal Buprenorphine 600mcg and oral Placebo, Oral placebo and buccal placebo, Oral immediate release oxycodone 10mg and buccal placebo, Buccal Buprenorphine 300mcg and oral Placebo
Pain Clinical Trial 2023: Buccal Buprenorphine Highlights & Side Effects. Trial Name: NCT05988710 — Phase 4
Buccal Buprenorphine (Opioid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05988710 — Phase 4
~75 spots leftby Oct 2026
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