Opioid Use DisorderPhase 1NCT05924022
Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering
A Phase 1 study testing Hyperbaric Oxygen Treatment Full and Hyperbaric Oxygen Treatment Partial Pressure in people with Opioid Use Disorder, run by Washington State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Hyperbaric Oxygen Treatment Full and Hyperbaric Oxygen Treatment Partial Pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 15 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spokane Regional Health District
Spokane, Washington, 99201
About this study
Official title: Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering in Human Subjects With Opioid Use Disorder
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).
Read the 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
- Being tested
- Hyperbaric Oxygen Treatment Full, Hyperbaric Oxygen Treatment Sham, Hyperbaric Oxygen Treatment Partial Pressure
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Treatment FullCombination 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.
Hyperbaric Oxygen Treatment ShamCombination 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.
Hyperbaric Oxygen Treatment Partial PressureCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Full treatment | Experimental | Participants are administered 100% oxygen in the HBOT chamber at 2.0 ATA Receives: Combination Product: Hyperbaric Oxygen Treatment Full |
| Partial pressure treatment | Active comparator | Participants are administered 100% oxygen in the HBOT chamber at 1.3 ATA Receives: Combination Product: Hyperbaric Oxygen Treatment Partial Pressure |
| Sham | Sham comparator | Participants are administered 21% oxygen n the HBOT chamber at 1.3 ATA. Receives: Combination Product: Hyperbaric Oxygen Treatment Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 study design is for two 5% methadone dose reductions spaced two weeks apart to examine whether treatment group is better able to sustain the reduction.
Measured: The investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start4 Dec 2023
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian Wilson, Washington State University
- Investigators
- Layton Matt, MD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924022
- Sponsor's protocol ID
- 20000
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering in Human Subjects With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05924022
- Acronym / sponsor ID
- 20000
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Full treatment | Experimental | Combination Product: Hyperbaric Oxygen Treatment FullParticipants are administered 100% oxygen in the HBOT chamber at 2.0 ATA |
| Partial pressure treatment | Active comparator | Combination Product: Hyperbaric Oxygen Treatment Partial PressureParticipants are administered 100% oxygen in the HBOT chamber at 1.3 ATA |
| Sham | Sham comparator | Combination Product: Hyperbaric Oxygen Treatment ShamParticipants are administered 21% oxygen n the HBOT chamber at 1.3 ATA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Treatment FullParticipants 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 | Full treatment |
| Hyperbaric Oxygen Treatment ShamParticipants 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 | Sham |
| Hyperbaric Oxygen Treatment Partial PressureParticipants 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. | Combination product | Partial pressure treatment |
Primary outcome
Change in Adjective Rating Scale of Withdrawal (ARSW)
Time frame: Subjects will be assessed for withdrawal signs and symptoms at week 1 and compared with the end of week 4.
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.
1 secondary outcome
Change in Methadone dose
Time frame: The investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Layton Matt, MD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperbaric Oxygen Treatment Full and Hyperbaric Oxygen Treatment Partial Pressure in people with Opioid Use Disorder, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adjective Rating Scale of Withdrawal (ARSW) (time frame: Subjects will be assessed for withdrawal signs and symptoms at week 1 and compared with the end of week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.