Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder

NCT06086275 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2023P002634
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Participants will be given naltrexone to produce opioid blockade to eliminate the risk for opioid dependence in individuals without OUD. Timed blood samples will be collected up to 24 hours.

Conditions

Opioid Use Disorder

Keywords

opioid use disorder; buprenorphine

Outcome Measures

Primary Outcomes (1)

• Plasma-Concentration Curves (AUC) of Buprenorphine

  The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 8, and 24 hours. Samples will be centrifuged and frozen until analysis.

  Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.

Secondary Outcomes (8)

• Maximum Plasma Concentration

  Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.

• Time to Maximum Plasma Concentration

  Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.

• Volume of Distribution

  Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.

• Elimination half-life

  Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.

• Total Clearance

  Baseline, 0.5, 1, 2, 4, 8, and 24 hours after study drug administration.

Study Arms (3)

8mg PO buprenorphine

EXPERIMENTAL

After the open-label period, the participant will receive 8mg PO, then 16mg PO will be administered in the following visit.

Drug: Buprenorphine

16mg PO buprenorphine

EXPERIMENTAL

After the open-label period, the participant will receive 16mg PO, then 8mg PO will be administered in the following visit.

Drug: Buprenorphine

0.15mg IV Dose

EXPERIMENTAL

The first dose administered will be fixed to an open-label 0.15mg IV dose.

Drug: Buprenorphine

Interventions

Buprenorphine DRUG

At each visit, the participant will receive a single dose of buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO.

0.15mg IV Dose; 16mg PO buprenorphine; 8mg PO buprenorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking adults aged 18 and above.
• In good physical health as determined by routine medical screening consisting of a complete physical exam, safety labs and EKG.
• Baseline vital signs with HR between 60 and 100, SBP between 90 and 160mmHg, and respiratory rate between 12 and 20 breaths per minute.
• Prior personal history of opioid use, therapeutic or non-therapeutic in past the 12 months.

You may not qualify if:

• DSM-5 diagnosis of any substance use disorder excluding tobacco.
• Presence of any alcohol, cannabis, opioids (including methadone, buprenorphine) or any other illicit substances on urine toxicology at any study visit, including cocaine, amphetamines, and benzodiazepines.
• Receiving treatment with opioid analgesic in last 60 days, or anticipate requiring opioids during the proposed trial, or up to 30 days after the trial completion
• Baseline PHQ-9 or GAD7 \> 10 (i.e. moderate depression/anxiety)
• History of chronic pain
• Psychotic disorder, active suicidality or homicidally, or any psychiatric condition that impair ability to provide informed consent.
• History of hypersensitivity or allergy to buprenorphine or naltrexone
• Pregnant or breastfeeding.
• Liver function test greater than 3 times upper normal limit.
• Receiving medications that are strong or moderate CYP34A inducers or inhibitors (including but not limited to ketoconazole, itraconazole, clarithromycin, fluconazole, erythromycin), in the past 30 days.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Utah: collaborator

Study Sites (1)

Brigham and Women's hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All portions will be open label
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will first receive the IV arm in fixed order, in an open-label fashion. Subsequently, participants will be randomized to the two PO.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 17, 2023
• Study Start: June 4, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (1)