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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 3.5 hours after study drug administration on each medication condition
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

5Treatment 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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) 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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
Group III: 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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
Group IV: 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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
Group V: 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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Placebo
2017
Completed Phase 4
~3500

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,659 Total Patients Enrolled
16 Trials studying Opioid Abuse
338,788 Patients Enrolled for Opioid Abuse
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,121 Total Patients Enrolled
1 Trials studying Opioid Abuse
118 Patients Enrolled for Opioid Abuse
Daniel Larach, MD, MSTR, MAPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

Buccal Buprenorphine (Opioid) Clinical Trial Eligibility Overview. Trial Name: NCT05988710 — Phase 4
Opioid Abuse Research Study Groups: Buccal Buprenorphine 300mcg and oral Placebo, Oral placebo and buccal placebo, Buccal Buprenorphine 600mcg and oral Placebo, Buccal Buprenorphine 900mcg and oral Placebo, Oral immediate release oxycodone 10mg and buccal placebo
Opioid Abuse 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

Frequently Asked Questions

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

Is this experiment accepting participants at present?

"According to the listings on clinicaltrials.gov, this investigation is not actively recruiting patients after having first been posted in September 1st of 2023 and last updated on August 8th of that same year. Nonetheless, there are still 479 other trials searching for participants at present."

Answered by AI

Would I be eligible to join this experiment?

"In order to be taken into consideration for this experiment, individuals in the 18-65 age bracket must have evidence of successful pain management. A total of 72 patients will be accepted."

Answered by AI

How might Buccal Buprenorphine 300 mcg endanger individuals?

"The safety of Buccal Buprenorphine 300 mcg scored a 3 on our team's scale, as this treatment has been granted approval for Phase 4 trial status."

Answered by AI

Are senior citizens being welcomed into this medical trial?

"To be applicable for this medical trial, a patient must fall within the age demographic of 18 to 65. 83 trials are accessible to minors and 343 clinical studies cater to people aged above 65."

Answered by AI

What are the research goals of this investigation?

"The primary study outcome, assessed from Baseline to 3.5 hours after drug administration for each condition, relates to the Quantitative Sensory Testing-based thermal pain tolerance in seconds. Secondary measures include a comparison of mean maximum effect scores between oxycodone 10 mg and placebo on a Drug Liking Visual Analog Scale (VAS; 0 representing strong disliking and 100 indicating strong liking), QST heat pain threshold which is an indicator of sensitivity to noxious stimuli, as well as differences in mean Emax values obtained through VAS Pain Intensity assessments (0 being no discomfort while 100 indicates extreme agony)."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Daniel Larach 2023. "Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05988710.
All > Probuphine
~48 spots leftby Oct 2026
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