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Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

NCT05924022 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-22

No results posted yet for this study

Summary

The aims of this study are to 1) explore the efficacy of hyperbaric oxygen therapy (HBOT) applied at two different pressures compared to sham treatment in relieving signs and symptoms (both physical and psychological) of opioid withdrawal in human subjects associated with methadone dose reductions; and 2): explore whether HBOT can increase the odds of successful methadone dose reduction in patients who are interested in tapering their opioid dose. The investigators aim to explore, through qualitative methods, individual's experiences with treatment for opioid use disorder (OUD).

Conditions

Interventions

COMBINATION_PRODUCT

Hyperbaric Oxygen Treatment Full

Participants in this active treatment arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT)100% oxygen and 2.0 ATA prior to and the day of medically supervised 5% methadone dose reductions while sitting in a wheelchair-accessible, multi-place sealed pressurized chamber for 90 minutes each session.

COMBINATION_PRODUCT

Hyperbaric Oxygen Treatment Sham

Participants in the sham condition arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT) 21% oxygen and 1.3 ATA prior to and the day of medically supervised 5% methadone dose reductions while sitting in a wheelchair-accessible, multi-place sealed pressurized chamber for 90 minutes each session receiving less than a fully pressurized 100% oxygen dose.

COMBINATION_PRODUCT

Hyperbaric Oxygen Treatment Partial Pressure

Participants in this partial treatment arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT)100% oxygen and 1.3 ATA prior to and the day of medically supervised 5% methadone dose reductions while sitting in a wheelchair-accessible, multi-place sealed pressurized chamber for 90 minutes each session.

Sponsors & Collaborators

  • Washington State University

    lead OTHER

Principal Investigators

  • Layton Matt, MD · Washington State University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-09-30
Completion
2025-12-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05924022 on ClinicalTrials.gov