Clinical trial NCT05988710: Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Official title: Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Analgesia
Abuse Opioids
Pain
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, double blind, double-dummy, placebo-controlled, crossover
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: Quantitative sensory testing (QST) thermal pain tolerance in seconds
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
Secondary outcomes:
measure: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: QST heat pain threshold
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: Visual Analog Scale (VAS) pain intensity
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS pain unpleasantness
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: McGill Pain Questionnaire - Short Form
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS alertness/drowsiness
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS any drug effects
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS good effects
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS feeling high
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS bad effects
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: VAS desire to use opioids
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: Opioid Adjective Rating Scale
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
measure: Temporal summation of pain (TSP)
timeFrame: Baseline through 3.5 hours after study drug administration on each medication condition
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel Larach, MD, MSTR, MA
role: PRINCIPAL_INVESTIGATOR
References: