Hyperbaric Oxygen Treatment for Opioid Use Disorder

Overseen By Marian Wilson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington State University

Must not be taking: Antabuse

Disqualifiers: Pregnancy, Emphysema, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking Antabuse for alcohol addiction.

What data supports the effectiveness of hyperbaric oxygen treatment for opioid use disorder?

Research shows that hyperbaric oxygen therapy can help with pain relief in various chronic pain conditions, suggesting it might have potential benefits for opioid use disorder by possibly interacting with opioid receptors. Additionally, it is used effectively in other medical conditions like wound healing and infections, indicating its broad therapeutic potential. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy safe for humans?

Hyperbaric oxygen therapy is generally safe for humans, but it can have side effects like ear pain due to pressure changes, claustrophobia (fear of confined spaces), and, rarely, oxygen toxicity leading to seizures. Most side effects are mild and manageable, especially when the therapy is supervised by trained professionals. ^{1 4 6 7 8}

How is hyperbaric oxygen treatment different from other treatments for opioid use disorder?

Hyperbaric oxygen treatment (HBOT) is unique because it involves breathing pure oxygen in a pressurized room, which may influence opioid receptors and provide pain relief, unlike traditional drug therapies that typically involve medication. This method is also used for other conditions like chronic pain and fracture healing, suggesting a novel approach to treating opioid use disorder. ^{1 3 9 10 11}

Research Team

Layton Matt, MD

Principal Investigator

Washington State University

Eligibility Criteria

This trial is for adults over 18 who are enrolled in a supervised opioid treatment program at the Spokane Regional Health District. Participants must be able to read, speak, and write English and provide written informed consent.

Inclusion Criteria

Enrollment in a supervised opioid treatment program at the Spokane Regional Health District

I am older than 18 years.

Ability to provide written informed consent.

Exclusion Criteria

I have emphysema.

Air cysts in the lung

I do not have any mental health conditions that would make it unsafe for me to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperbaric oxygen therapy (HBOT) at different pressures or sham treatment during methadone tapering

4 weeks

Weekly visits for HBOT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Long-term follow-up

Participants' methadone dose changes are assessed at one month and three months from baseline

3 months

Treatment Details

Interventions

• Hyperbaric Oxygen Treatment

Trial Overview The study tests if hyperbaric oxygen therapy (HBOT) can help with physical and psychological symptoms of opioid withdrawal during methadone dose reduction compared to a sham treatment. It also examines HBOT's role in increasing success rates of tapering off opioids.

Participant Groups

Group I: Full treatment Experimental Treatment 1 Intervention

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

Group II: Partial pressure treatment Active Control 1 Intervention

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

Group III: Sham Placebo Group 1 Intervention

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

Hyperbaric Oxygen Treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hyperbaric Oxygen Therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Diabetic foot ulcers
• Wound healing

Approved in European Union as Hyperbaric Oxygen Therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Diabetic foot ulcers
• Wound healing
• Radiation necrosis

Approved in Canada as Hyperbaric Oxygen Therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Diabetic foot ulcers
• Wound healing

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

Findings from Research

Mice that developed tolerance to opioid agonists showed a reduced pain-relieving response to hyperbaric oxygen (HBO2) therapy, indicating that opioid receptors play a role in the analgesic effects of HBO2.

The study found that both μ-opioid and κ-opioid receptors are involved in mediating the acute pain relief provided by HBO2, suggesting that this therapy may be less effective in patients who are tolerant to opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced antinociceptive responsiveness to hyperbaric oxygen in opioid-tolerant mice. Zhang, Y., Stolz, PA., Shirachi, DY., et al.[2015]

Hyperbaric oxygen therapy (HBO) is effective in improving tissue oxygenation and promoting wound healing, making it a key treatment for conditions like severe carbon monoxide poisoning and diabetic foot wounds.

HBO is considered safe with minimal adverse effects when administered according to standard protocols, although further research is needed to explore its efficacy for other potential uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy (HBO): current standing]. Haltern, C., Siekmann, UP., Rump, AF., et al.[2006]

Hyperbaric oxygen (HBO) therapy is effective in treating various skin disorders, including chronic non-healing ulcers, bacterial infections, and fungal infections, highlighting its role as both a primary treatment and an adjunct to conventional therapies.

While HBO therapy shows promise in clinical practice, it is important to be aware of its contraindications and potential toxic effects, ensuring patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyper Baric Oxygen Therapy. Dutta, RK., Kumar, R.[2019]

Hyperbaric oxygen (HBO) therapy, which involves administering 100% oxygen under pressure, is an evidence-based treatment for various surgical conditions, including gas gangrene, crush injuries, and necrotizing infections, among others.

When used appropriately and under the supervision of trained medical professionals, HBO therapy can significantly enhance healing and improve outcomes in surgical patients, although there is a need for better education and more facilities to support its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen and surgery. MacFarlane, C., Cronjé, FJ.[2017]

Hyperbaric oxygenation (HBO) therapy significantly inhibits the proliferation of both normal and cancerous mammary cells, showing a time-dependent effect across all cell types studied, including primary and metastatic tumor cells.

HBO enhances the effectiveness of certain chemotherapy drugs like melphalan, gemcitabine, and paclitaxel, while not increasing cell death, suggesting it could be a beneficial adjunct therapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen inhibits benign and malignant human mammary epithelial cell proliferation. Granowitz, EV., Tonomura, N., Benson, RM., et al.[2013]

Hyperbaric oxygen therapy (HBOT) is associated with a higher incidence of adverse effects (30.11%) compared to control groups (10.43%), particularly when the treatment involves more than 10 sessions or chamber pressures exceed 2.0 ATA.

The most common side effect reported was ear discomfort, indicating that while HBOT can be beneficial, careful monitoring for adverse reactions is necessary, especially under specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. Zhang, Y., Zhou, Y., Jia, Y., et al.[2023]

The most common side effects of hyperbaric oxygen (HBO2) therapy are middle ear barotrauma, affecting up to 2% of patients, which can be managed through techniques like autoinflation or tympanostomy tubes.

While rare, more severe side effects from HBO2 therapy can include oxygen toxicity leading to issues like progressive myopia and pulmonary dyspnea, with serious complications like seizures occurring at higher oxygen pressures, particularly in patients with acidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of hyperbaric oxygen therapy. Camporesi, EM.[2014]

In a review of over 1.5 million hyperbaric oxygen therapy treatments, only 0.68% were linked to adverse events, indicating that serious complications are rare.

The most common issues reported were barotrauma and confinement anxiety, while severe events like oxygen toxicity occurred in less than 0.05 per 1000 treatments, suggesting that HBO therapy is a safe and low-risk treatment when following proper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. Jokinen-Gordon, H., Barry, RC., Watson, B., et al.[2022]

In a retrospective review of 181 patients treated with hyperbaric oxygen (HBO) therapy, 81.8% experienced successful or improved outcomes across various conditions, indicating its efficacy as an adjunctive treatment.

Specific success rates included 95.7% for osteoradionecrosis and 88.1% for soft tissue radiation necrosis, suggesting HBO is particularly effective for these indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment outcome for different indications from a single center. Skeik, N., Porten, BR., Isaacson, E., et al.[2015]

Hyperbaric oxygenation (HBO) significantly accelerates the elimination of alcoholic abstinence syndrome (AAS) symptoms in 40 patients, compared to those receiving only drug therapy.

HBO treatment notably reduces psychoneurological symptoms and improves heart function, especially when administered early in Stage II AAS, with optimal results seen from two sessions daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of hyperbaric oxygenation on the dynamics of the alcohol abstinence syndrome]. Epifanova, NM., Isakov, IuV., Churkin, EA.[2016]

This systematic review found no clinical trials that provided evidence for the effectiveness of hyperbaric oxygen therapy (HBOT) in treating delayed healing or established non-union of bony fractures, indicating a lack of supporting data.

The authors concluded that high-quality clinical trials are necessary to determine whether HBOT has any beneficial role in managing these types of bone injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Bennett, MH., Stanford, R., Turner, R.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Reduced antinociceptive responsiveness to hyperbaric oxygen in opioid-tolerant mice. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy (HBO): current standing]. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Hyper Baric Oxygen Therapy. [2019]

4. South Africa pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen and surgery. [2017]

5. Greece pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen inhibits benign and malignant human mammary epithelial cell proliferation. [2013]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Side effects of hyperbaric oxygen therapy. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment outcome for different indications from a single center. [2015]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of hyperbaric oxygenation on the dynamics of the alcohol abstinence syndrome]. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. [2018]