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New treatment option for Analgesia
Official title Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
ClinicalTrials.gov ID: NCT05988710
What this study is testing
What is Buccal Buprenorphine 300 mcg?
Buccal Buprenorphine 300 mcg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for analgesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.