AnalgesiaPhase 4NCT05988710
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
A Phase 4 study testing Buccal Buprenorphine 300 mcg, Buccal Buprenorphine 600 mcg and Buccal Buprenorphine 900 mcg in people with Analgesia and Abuse Opioids, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Abuse Opioids, Pain
- What is being tested?
- Buccal Buprenorphine 300 mcg, Buccal Buprenorphine 600 mcg and Buccal Buprenorphine 900 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2023to Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37069
Daniel Larach Larach, MD, MSTR, MA, 615-322-6033, daniel.larach@vumc.org
Gail Mayo, 6159361705, gail.mayo@vumc.org
About this study
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.
- Conditions
- Analgesia, Abuse Opioids, Pain
- Being tested
- Buccal Buprenorphine 300 mcg, Buccal Buprenorphine 600 mcg, Buccal Buprenorphine 900 mcg, Buccal Placebo, Oral Placebo
- Medical subject headings
- Agnosia, Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Buprenorphine 300 mcgDrug
buprenorphine for 300mcg buccal administration
Buccal Buprenorphine 600 mcgDrug
buprenorphine for 600mcg buccal administration
Buccal Buprenorphine 900 mcgDrug
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.
Buccal PlaceboDrug
Placebo for buccal administration
Oral PlaceboDrug
Placebo for oral administration
Oral immediate-release oxycodone 10mgDrug
Immediate-release oxycodone for 10 mg oral administration
Buccal Buprenorphine 450mcgDrug
buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.
| Study group | Role | What they receive |
|---|---|---|
| Buccal Buprenorphine 300mcg and oral Placebo | Experimental | In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. Receives: Drug: Buccal Buprenorphine 300 mcg; Drug: Oral Placebo |
| Buccal Buprenorphine 600mcg and oral Placebo | Experimental | In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. Receives: Drug: Buccal Buprenorphine 600 mcg; Drug: Oral Placebo |
| Buccal Buprenorphine 900mcg and oral Placebo | Experimental | In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. Receives: Drug: Buccal Buprenorphine 900 mcg; Drug: Oral Placebo |
| Oral immediate release oxycodone 10mg and buccal placebo | Active comparator | In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. Receives: Drug: Buccal Placebo; Drug: Oral immediate-release oxycodone 10mg |
| Oral placebo and buccal placebo | Placebo comparator | In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. Receives: Drug: Buccal Placebo; Drug: Oral Placebo |
| Buccal Buprenorphine 450mcg and oral Placebo | Experimental | In randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. Receives: Drug: Oral Placebo; Drug: Buccal Buprenorphine 450mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Difference in mean Emax of the drug liking VAS between oxycodone 10 mg and an equianalgesic dose of buprenorphine conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
Quantitative sensory testing (QST) thermal pain tolerance in seconds
Mean time in seconds elapsed from onset of the heat pain stimulus to participants withdrawal from the stimulus. Heat pain tolerance is an indicator of pain sensitivity. This will determine the equianalgesic dose of buccal buprenorphine compared to oxycodone 10 mg. Equivalence to oxycodone will be defined as the buprenorphine does that produces a mean thermal pain tolerance increase within 0.5 standard deviation of the oxycodone. response.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
Secondary outcomes (14)
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Measured: 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
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between oxycodone 10 mg and placebo conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
QST heat pain threshold
Mean time in seconds elapsed from onset of the thermal stimulus to the point at which heat stimulus is first experienced as painful. Thermal pain threshold is an indicator of pain sensitivity.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
Visual Analog Scale (VAS) pain intensity
Difference in mean Emax of the pain intensity VAS between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS pain intensity is a measure of experienced pain intensity on 0 to 100 scale when 0 is no pain and 100 is worst pain imaginable.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS pain unpleasantness
Difference in mean Emax of the pain unpleasantness VAS between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS pain unpleasantness is a measure of experienced pain unpleasantness on 0 to 100 scale, when 0 is no unpleasantness and 100 is most unpleasant imaginable.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
McGill Pain Questionnaire - Short Form
Mean of maximum McGill Pain Questionnaire - Short Form score between oxycodone 10mg, equianalgesic dose of buprenorphine and placebo. The score ranges from 0-33 where 0 represents no pain and 33 represents most intense pain. Positive change values indicate decreased pain responsiveness.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS alertness/drowsiness
Difference in mean Emax of the VAS alertness/drowsiness between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. The VAS alertness/drowsiness assesses alertness and drowsiness following drug administration on 0 to 100 sale, when 0 is extreme drowsiness, 50 is neutral, and 100 is extreme alertness.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS any drug effects
Difference in mean Emax of the VAS any drug effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS any drug effects assesses presence of any drug effects felt by participant on 0 to 100 scale, when 0 is no drug effects and 100 is extreme drug effects.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS good effects
Difference in mean Emax of the VAS good effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS good effects assesses presence of drug effects characterized as good felt by participant on scale 0 to 100 when 0 is no good drug effects and 100 is extreme good drug effects.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS feeling high
Difference in mean Emax of the VAS feeling high between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS feeling high assesses presence of "feeling high" by participant on 0 to 100 scale when o is not feeling high at all and 100 is feeling extremely high.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS bad effects
Difference in mean Emax of the VAS bad effects between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS bad effects assesses presence of drug effects characterized as bad felt by participant on 0 to 100 scale when 0 is no bad drug effects and 100 is extreme bad drug effects.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
VAS desire to use opioids
Difference in mean Emax of the VAS desire to use opioids between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS desire to use opioids assesses participant's desire to use opioids on a 0-100 scale when 0 is no desire to use opioids and 100 is extreme desire to use opioids.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
Opioid Adjective Rating Scale
Difference in mean Emax of the VAS Opioid Adjective Rating Scale between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo. VAS Opioid Adjective Rating Scale is a 12 item questionnaire which evaluates common sensory and somatic effects of opioid (e.g., itching, vomiting, sweating, nausea, dry mouth). Each effect is rated on 0 to 4 scale when 0 is not at all and 4 is extremely.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
Temporal summation of pain (TSP)
Change in pain intensity between first and most painful TSP stimuli (mean of two TSP trials) compared between oxycodone 10 mg, equianalgesic dose of buprenorphine and placebo conditions. Pain intensity will be measured on a 0-10 Numeric Rating Scale when when 0 is no pain and 100 is worst pain imaginable.
Measured: Baseline through 3.5 hours after study drug administration on each medication condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Oct 2023
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double blind, double-dummy, placebo-controlled, crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Daniel Larach, Vanderbilt University Medical Center
- Investigators
- Daniel Larach, MD, MSTR, MA, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988710
- Sponsor's protocol ID
- 222204
- Other IDs
- 1K23DA057387
- Status last verified
- Jan 2026
- First submitted
- 1 Aug 2023
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
- ClinicalTrials.gov ID
- NCT05988710
- Acronym / sponsor ID
- 222204
- Conditions
- Analgesia, Abuse Opioids, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- randomized, double blind, double-dummy, placebo-controlled, crossover
| Arm | Type | Receives |
|---|---|---|
| Buccal Buprenorphine 300mcg and oral Placebo | Experimental | Drug: Buccal Buprenorphine 300 mcg, Drug: Oral PlaceboIn randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. |
| Buccal Buprenorphine 600mcg and oral Placebo | Experimental | Drug: Buccal Buprenorphine 600 mcg, Drug: Oral PlaceboIn randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. |
| Buccal Buprenorphine 900mcg and oral Placebo | Experimental | Drug: Buccal Buprenorphine 900 mcg, Drug: Oral PlaceboIn randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. |
| Oral immediate release oxycodone 10mg and buccal placebo | Active comparator | Drug: Buccal Placebo, Drug: Oral immediate-release oxycodone 10mgIn randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. |
| Oral placebo and buccal placebo | Placebo comparator | Drug: Buccal Placebo, Drug: Oral PlaceboIn randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. |
| Buccal Buprenorphine 450mcg and oral Placebo | Experimental | Drug: Oral Placebo, Drug: Buccal Buprenorphine 450mcgIn randomized order (crossover) across 5 laboratory sessions approximately 5 days apart, participants will receive: 1) Buccal buprenorphine 300 mcg and oral placebo, 2) Buccal buprenorphine 450 mcg and oral placebo 3) Buccal buprenorphine 600 mcg and oral placebo, 4) Buccal buprenorphine 900 mg and oral placebo, 5) oral immediate-release oxycodone 10mg and oral placebo, or 6) buccal placebo and oral placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal Buprenorphine 300 mcgbuprenorphine for 300mcg buccal administration | Drug | Buccal Buprenorphine 300mcg and oral Placebo |
| Buccal Buprenorphine 600 mcgbuprenorphine for 600mcg buccal administration | Drug | Buccal Buprenorphine 600mcg and oral Placebo |
| Buccal Buprenorphine 900 mcgbuprenorphine 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 Buprenorphine 900mcg and oral Placebo |
| Buccal PlaceboPlacebo for buccal administration | Drug | Oral immediate release oxycodone 10mg and buccal placebo, Oral placebo and buccal placebo |
| Oral PlaceboPlacebo for oral administration | Drug | Buccal Buprenorphine 300mcg and oral Placebo, Buccal Buprenorphine 450mcg and oral Placebo, Buccal Buprenorphine 600mcg and oral Placebo, Buccal Buprenorphine 900mcg and oral Placebo, Oral placebo and buccal placebo |
| Oral immediate-release oxycodone 10mgImmediate-release oxycodone for 10 mg oral administration | Drug | Oral immediate release oxycodone 10mg and buccal placebo |
| Buccal Buprenorphine 450mcgbuprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm. | Drug | Buccal Buprenorphine 450mcg and oral Placebo |
Primary outcome
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
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
Difference in mean Emax of the drug liking VAS between oxycodone 10 mg and an equianalgesic dose of buprenorphine conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
Quantitative sensory testing (QST) thermal pain tolerance in seconds
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
Mean time in seconds elapsed from onset of the heat pain stimulus to participants withdrawal from the stimulus. Heat pain tolerance is an indicator of pain sensitivity. This will determine the equianalgesic dose of buccal buprenorphine compared to oxycodone 10 mg. Equivalence to oxycodone will be defined as the buprenorphine does that produces a mean thermal pain tolerance increase within 0.5 standard deviation of the oxycodone. response.
14 secondary outcomes
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale between equianalgesic dose of buprenorphine and placebo conditions
Time frame: 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
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
QST heat pain threshold
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
Visual Analog Scale (VAS) pain intensity
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS pain unpleasantness
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
McGill Pain Questionnaire - Short Form
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS alertness/drowsiness
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS any drug effects
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS good effects
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS feeling high
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS bad effects
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
VAS desire to use opioids
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
Opioid Adjective Rating Scale
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
Temporal summation of pain (TSP)
Time frame: Baseline through 3.5 hours after study drug administration on each medication condition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Larach, MD, MSTR, MA principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buccal Buprenorphine 300 mcg, Buccal Buprenorphine 600 mcg and Buccal Buprenorphine 900 mcg in people with Analgesia and Abuse Opioids, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Larach, MD, MSTR, MA (615-322-6033, daniel.larach@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline through 3.5 hours after study drug administration on each medication condition). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.