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Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

NCT ID: NCT05988710

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Analgesia Abuse Opioids Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized, double blind, double-dummy, placebo-controlled, crossover
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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 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.

Group Type EXPERIMENTAL

Buccal Buprenorphine 300 mcg

Intervention Type DRUG

buprenorphine for 300mcg buccal administration

Oral Placebo

Intervention Type DRUG

Placebo for oral administration

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 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.

Group Type EXPERIMENTAL

Buccal Buprenorphine 600 mcg

Intervention Type DRUG

buprenorphine for 600mcg buccal administration

Oral Placebo

Intervention Type DRUG

Placebo for oral administration

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 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.

Group Type EXPERIMENTAL

Buccal Buprenorphine 900 mcg

Intervention Type DRUG

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.

Oral Placebo

Intervention Type DRUG

Placebo for oral administration

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 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.

Group Type ACTIVE_COMPARATOR

Buccal Placebo

Intervention Type DRUG

Placebo for buccal administration

Oral immediate-release oxycodone 10mg

Intervention Type DRUG

Immediate-release oxycodone for 10 mg oral administration

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 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.

Group Type PLACEBO_COMPARATOR

Buccal Placebo

Intervention Type DRUG

Placebo for buccal administration

Oral Placebo

Intervention Type DRUG

Placebo for oral administration

Buccal Buprenorphine 450mcg 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 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.

Group Type EXPERIMENTAL

Oral Placebo

Intervention Type DRUG

Placebo for oral administration

Buccal Buprenorphine 450mcg

Intervention Type DRUG

buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

Interventions

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Buccal Buprenorphine 300 mcg

buprenorphine for 300mcg buccal administration

Intervention Type DRUG

Buccal Buprenorphine 600 mcg

buprenorphine for 600mcg buccal administration

Intervention Type 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.

Intervention Type DRUG

Buccal Placebo

Placebo for buccal administration

Intervention Type DRUG

Oral Placebo

Placebo for oral administration

Intervention Type DRUG

Oral immediate-release oxycodone 10mg

Immediate-release oxycodone for 10 mg oral administration

Intervention Type DRUG

Buccal Buprenorphine 450mcg

buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

Intervention Type DRUG

Eligibility Criteria

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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 (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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Daniel Larach

Asst Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Larach, MD, MSTR, MA

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Larach, MD, MSTR, MA

Role: CONTACT

Phone: 615-322-6033

Email: [email protected]

Gail Mayo

Role: CONTACT

Phone: 6159361705

Email: [email protected]

Facility Contacts

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Daniel Larach Larach, MD, MSTR, MA

Role: primary

Gail Mayo

Role: backup

Other Identifiers

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1K23DA057387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

222204

Identifier Type: -

Identifier Source: org_study_id