Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Обзор

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.

Вмешательства

• Препарат Buccal Buprenorphine 300 mcg
  buprenorphine for 300mcg buccal administration
• Препарат Buccal Buprenorphine 600 mcg
  buprenorphine for 600mcg buccal administration
• Препарат 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.
• Препарат Buccal Placebo
  Placebo for buccal administration
• Препарат Oral Placebo
  Placebo for oral administration
• Препарат Oral immediate-release oxycodone 10mg
  Immediate-release oxycodone for 10 mg oral administration
• Препарат Buccal Buprenorphine 450mcg
  buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

Первичные конечные точки

• 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 [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• Quantitative sensory testing (QST) thermal pain tolerance in seconds [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]

Вторичные конечные точки (12)

• Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions [Срок оценки: 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 [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• QST heat pain threshold [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• Visual Analog Scale (VAS) pain intensity [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS pain unpleasantness [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• McGill Pain Questionnaire - Short Form [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS alertness/drowsiness [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS any drug effects [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS good effects [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS feeling high [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS bad effects [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]
• VAS desire to use opioids [Срок оценки: Baseline through 3.5 hours after study drug administration on each medication condition]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT05988710 · 222204 · 1K23DA057387

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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