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Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

Primary Purpose

Opioid Use Disorder

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hyperbaric Oxygen Treatment Full
Hyperbaric Oxygen Treatment Partial
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Full treatment

    Partial treatment

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 16, 2023
    Last Updated
    June 26, 2023
    Sponsor
    Washington State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05924022
    Brief Title
    Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering
    Official Title
    Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering in Human Subjects With Opioid Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorder

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Full treatment
    Arm Type
    Experimental
    Arm Description
    Participants are administered 100% oxygen in the HBOT chamber at 2.0 ATA
    Arm Title
    Partial treatment
    Arm Type
    Sham Comparator
    Arm Description
    Participants are administered 21% oxygen in the HBOT chamber at <1.3 ATA.
    Intervention Type
    Biological
    Intervention Name(s)
    Hyperbaric Oxygen Treatment Full
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Hyperbaric Oxygen Treatment Partial
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Adjective Rating Scale of Withdrawal (ARSW)
    Description
    Self-reported opioid withdrawal symptoms will be captured using an online survey and compared from week 1 to week 4 timepoint.
    Time Frame
    Subjects will be assessed for withdrawal signs and symptoms at week 1 and compared with the end of week 4.
    Secondary Outcome Measure Information:
    Title
    Change in Methadone dose
    Description
    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.
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marian Wilson, PhD
    Phone
    509-324-7443
    Email
    marian.wilson@wsu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Layton Matt, MD
    Organizational Affiliation
    Washington State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

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