Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

Sponsor

Washington State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05924022

Collaborator

(none)

Enrollment

Arms

18.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aims of this study are to 1) explore the efficacy of hyperbaric oxygen therapy (HBOT) 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).

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Biological: Hyperbaric Oxygen Treatment Full Biological: Hyperbaric Oxygen Treatment Partial	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Only the HBOT personnel will be aware of the treatment assignments; the rest of the research team and participants will be blinded to condition.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jun 20, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Full treatment Participants are administered 100% oxygen in the HBOT chamber at 2.0 ATA	Biological: Hyperbaric Oxygen Treatment Full Participants in the active treatment arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT) 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.
Sham Comparator: Partial treatment Participants are administered 21% oxygen in the HBOT chamber at <1.3 ATA.	Biological: Hyperbaric Oxygen Treatment Partial Participants in the sham condition arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT) 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.

Arm

Intervention/Treatment

Experimental: Full treatment

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

Biological: Hyperbaric Oxygen Treatment Full

Participants in the active treatment arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT) 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.

Sham Comparator: Partial treatment

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

Biological: Hyperbaric Oxygen Treatment Partial

Participants in the sham condition arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT) 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.

Outcome Measures

Primary Outcome Measures

Change in Adjective Rating Scale of Withdrawal (ARSW) [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.

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Washington State University

Investigators

Principal Investigator: Layton Matt, MD, Washington State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marian Wilson, Associate Professor, Washington State University

ClinicalTrials.gov Identifier:

NCT05924022

Other Study ID Numbers:

20000

First Posted:

Jun 29, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Opioid-Related Disorders

Study Results

No Results Posted as of Jun 29, 2023