RECRUITING

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Quick Facts

Study Start:2023-10-19
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05988710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Intact cognitive status and ability to provide informed consent
  2. * Ability to read and write in English sufficiently to understand and complete study questionnaires
  3. * Age 18-65
  4. * 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
  1. * Liver/kidney disease
  2. * Chronic pain
  3. * Current/prior substance use disorder
  4. * Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility)
  5. * Seizure disorder
  6. * Certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders)
  7. * Recent use of medications that may interfere with study drug metabolism
  8. * Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session)
  9. * The presence of any medical conditions felt by the study physician to render participant unsafe
  10. * Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs

Contacts and Locations

Study Contact

Daniel Larach, MD, MSTR, MA
CONTACT
615-322-6033
daniel.larach@vumc.org
Gail Mayo
CONTACT
6159361705
gail.mayo@vumc.org

Principal Investigator

Daniel Larach, MD, MSTR, MA
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37069
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Daniel Larach, MD, MSTR, MA, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-19
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-10-19
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Analgesia
  • Abuse Opioids
  • Pain