Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
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ClinicalTrials.gov Identifier: NCT05988710 |
Recruitment Status :
Recruiting
First Posted : August 14, 2023
Last Update Posted : October 27, 2023
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Condition or disease | Intervention/treatment | Phase |
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Analgesia Abuse Opioids Pain | Drug: Buccal Buprenorphine 300 mcg Drug: Buccal Buprenorphine 600 mcg Drug: Buccal Buprenorphine 900 mcg Drug: Buccal Placebo Drug: Oral Placebo Drug: Oral immediate-release oxycodone 10mg | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | randomized, double blind, double-dummy, placebo-controlled, crossover |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Other |
Official Title: | Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia |
Actual Study Start Date : | October 19, 2023 |
Estimated Primary Completion Date : | October 2026 |
Estimated Study Completion Date : | October 2026 |
Arm | Intervention/treatment |
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Experimental: Buccal Buprenorphine 300mcg and oral Placebo
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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
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Drug: Buccal Buprenorphine 300 mcg
buprenorphine for 300mcg buccal administration Drug: Oral Placebo Placebo for oral administration |
Experimental: Buccal Buprenorphine 600mcg and oral Placebo
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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
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Drug: Buccal Buprenorphine 600 mcg
buprenorphine for 600mcg buccal administration Drug: Oral Placebo Placebo for oral administration |
Experimental: Buccal Buprenorphine 900mcg and oral Placebo
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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
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Drug: Buccal Buprenorphine 900 mcg
buprenorphine for 900mcg buccal administration Drug: Oral Placebo Placebo for oral administration |
Active Comparator: Oral immediate release oxycodone 10mg and buccal placebo
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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
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Drug: Buccal Placebo
Placebo for buccal administration Drug: Oral immediate-release oxycodone 10mg Immediate-release oxycodone for 10 mg oral administration |
Placebo Comparator: Oral placebo and buccal placebo
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 600 mcg and oral placebo, 3) Buccal buprenorphine 900 mg and oral placebo, 4) oral immediate-release oxycodone 10mg and oral placebo, or 5) buccal placebo and oral placebo.
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Drug: Buccal Placebo
Placebo for buccal administration Drug: Oral Placebo Placebo for oral administration |
- 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.
- 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 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).
- 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 ]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).
- QST heat pain threshold [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- Visual Analog Scale (VAS) pain intensity [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS pain unpleasantness [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- McGill Pain Questionnaire - Short Form [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS alertness/drowsiness [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS any drug effects [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS good effects [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS feeling high [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS bad effects [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- VAS desire to use opioids [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- Opioid Adjective Rating Scale [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
- Temporal summation of pain (TSP) [ Time Frame: Baseline through 3.5 hours after study drug administration on each medication condition ]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.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05988710
Contact: Daniel Larach, MD, MSTR, MA | 615-322-6033 | daniel.larach@vumc.org | |
Contact: Gail Mayo | 6159361705 | gail.mayo@vumc.org |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37069 | |
Contact: Daniel Larach Larach, MD, MSTR, MA 615-322-6033 daniel.larach@vumc.org | |
Contact: Gail Mayo 6159361705 gail.mayo@vumc.org |
Principal Investigator: | Daniel Larach, MD, MSTR, MA | Vanderbilt University Medical Center |
Responsible Party: | Daniel Larach, Asst Professor of Anesthesiology, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT05988710 |
Other Study ID Numbers: |
222204 1K23DA057387 ( U.S. NIH Grant/Contract ) |
First Posted: | August 14, 2023 Key Record Dates |
Last Update Posted: | October 27, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Agnosia Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Oxycodone Buprenorphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |