NCT05924022

Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering in Human Subjects With Opioid Use Disorder

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Washington State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The investigators will conduct a prospective, randomized, sham treatment-controlled trial to examine the efficacy of HBOT for improving signs and symptoms of opioid withdrawal in methadone-maintained OUD patients as they undergo two planned methadone dose reductions spaced two weeks apart. A participant sample size of 24 was chosen based on power analysis guided by the investigators' earlier study that indicate that clinically meaningful results can be found with a minimum of 8 per group related to variables of highest interest i.e., pain and withdrawal symptoms. Additionally to this trial, participants will be asked to partake in a semi-structured interview in which they will be asked to discuss (1) Beginning Treatment, (2) Life in Recovery, and (3) HBOT \& Further Treatment. Edited 11/23/24: An additional study arm was added to better address the question about the level of HBOT needed for effects. The new participant sample size of 36 was chosen based on power analysis guided by our earlier study that indicate that clinically meaningful results can be found with a minimum of 8 per group related to variables of highest interest i.e., pain and withdrawal symptoms. Participants will be randomized into one of three trial arms: (active arm of n = 12 in HBOT 100% oxygen and 2.0 ATA, partial 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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2023-06-29
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study