Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

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

Age range

18–65 years

Sex

All

Healthy volunteers

Yes

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

Location