Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

NCT05924022 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 20000
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Adjective Rating Scale of Withdrawal (ARSW)

  Self-reported opioid withdrawal symptoms will be captured using an online survey and compared from week 1 to week 4 timepoint. Score is summed from 16 items with a possible range of 0 to 144.

  Subjects will be assessed for withdrawal signs and symptoms at week 1 and compared with the end of week 4.

Secondary Outcomes (1)

• Change in Methadone dose

  The investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained

Study Arms (3)

Full treatment

EXPERIMENTAL

Participants are administered 100% oxygen in the HBOT chamber at 2.0 ATA

Combination Product: Hyperbaric Oxygen Treatment Full

Partial pressure treatment

ACTIVE COMPARATOR

Participants are administered 100% oxygen in the HBOT chamber at 1.3 ATA

Combination Product: Hyperbaric Oxygen Treatment Partial Pressure

Sham

SHAM COMPARATOR

Participants are administered 21% oxygen n the HBOT chamber at 1.3 ATA.

Combination Product: Hyperbaric Oxygen Treatment Sham

Interventions

Hyperbaric Oxygen Treatment Full COMBINATION_PRODUCT

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.

Full treatment

Hyperbaric Oxygen Treatment Sham COMBINATION_PRODUCT

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.

Sham

Hyperbaric Oxygen Treatment Partial Pressure COMBINATION_PRODUCT

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.

Partial pressure treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in a supervised opioid treatment program at the Spokane Regional Health District
• Age greater than 18 years
• Ability to read, speak, and write English
• Ability to provide written informed consent.

You may not qualify if:

• Pregnancy
• Any other medical or psychiatric condition that the PI, Co-PI (physician of record) or the Spokane Hyperbaric Center medical director determine might compromise safe study participation in the HBOT clinic (including but not limited to active psychosis, history of frequent psychiatric hospitalizations, severe anxiety with claustrophobia, aggression)
• Upper respiratory infection
• Emphysema
• Air cysts in the lung
• History of thoracic or ear surgery
• Taking the medication Antabuse for alcohol addiction
• High fever.

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Spokane Regional Health District

Spokane, Washington, 99201, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Layton Matt, MD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the HBOT personnel will be aware of the treatment assignments; the rest of the research team and participants will be blinded to condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized into 1 of 2 trial arms that will receive: 1) a 2-day medically-supervised full-dose HBOT treatment, or 2) a 2-day sub-therapeutic dose HBOT condition as a placebo control. Both groups will be receiving standard of care for addiction withdrawal symptoms, as managed and provided by their clinic physician and neither the full or sub-therapeutic HBOT dose are expected to affect their ongoing treatment. Updated to 3 arms 11/23/24: Participants will be randomized into one of three trial arms: (active arm of n = 12 in HBOT 100% oxygen and 2.0 ATA, active arm of n = 12 in HBOT 100% oxygen and 1.3 ATA, and sham arm of n = 12 in HBOT 21% oxygen and 1.3 ATA). All groups will be receiving standard of care for addiction withdrawal symptoms, as managed and provided by their clinic physician and neither the full or sub-therapeutic HBOT dose are expected to affect their ongoing treatment.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 29, 2023
• Study Start: December 4, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)