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Recruiting NCT05988710

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Phase IV Interventional Analgesia Abuse Opioids Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buccal Buprenorphine 300 mcg, Buccal Buprenorphine 600 mcg, Buccal Buprenorphine 900 mcg, Buccal Placebo.
Who it may be relevant to
Registry conditions: Analgesia, Abuse Opioids, Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs.

Interventions

  • Drug Buccal Buprenorphine 300 mcg
    buprenorphine for 300mcg buccal administration
  • Drug Buccal Buprenorphine 600 mcg
    buprenorphine for 600mcg buccal administration
  • Drug Buccal Buprenorphine 900 mcg
    buprenorphine for 900mcg buccal administration. Note: This arm has been discontinued as of 06/25/2024 and has been replaced with the 450mcg buprenorphine buccal administration arm.
  • Drug Buccal Placebo
    Placebo for buccal administration
  • Drug Oral Placebo
    Placebo for oral administration
  • Drug Oral immediate-release oxycodone 10mg
    Immediate-release oxycodone for 10 mg oral administration
  • Drug Buccal Buprenorphine 450mcg
    buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

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 [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • Quantitative sensory testing (QST) thermal pain tolerance in seconds [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
Secondary outcome measures (12)
  • Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • QST heat pain threshold [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • Visual Analog Scale (VAS) pain intensity [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS pain unpleasantness [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • McGill Pain Questionnaire - Short Form [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS alertness/drowsiness [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS any drug effects [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS good effects [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS feeling high [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS bad effects [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]
  • VAS desire to use opioids [Time frame: Baseline through 3.5 hours after study drug administration on each medication condition]

Eligibility criteria

Inclusion criteria

  • Intact cognitive status and ability to provide informed consent
  • Ability to read and write in English sufficiently to understand and complete study questionnaires
  • Age 18-65
  • Opioid-naive status (defined as no use of full mu-opioid receptor (MOR) agonist, partial MOR agonist, or mixed agonist/antagonist medications for the prior 3 months by patient report

Exclusion criteria

  • Liver/kidney disease
  • Chronic pain
  • Current/prior substance use disorder
  • Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility)
  • Seizure disorder
  • Certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders)
  • Recent use of medications that may interfere with study drug metabolism
  • Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session)
  • The presence of any medical conditions felt by the study physician to render participant unsafe
  • Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs (explicitly including moderate-to-severe nausea or vomiting with prior opioids)
  • Recent use of marijuana, delta-8 THC, CBD, and similar products
  • Recent use of kratom
  • Severe asthma
  • Long QT syndrome
  • Parkinson disease
  • Weight <60 kg

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT05988710 · 222204 · 1K23DA057387

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗