Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924022
• Other study ID #: 20000
• Status: Recruiting
• Phase: Phase 1
• Start date: December 4, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: Washington State University
• Contact: Marian Wilson, PhD
• Phone: 509-324-7443
• Email: marian.wilson[@]wsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Combination Product:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Spokane Regional Health District	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Subjects will be assessed for withdrawal signs and symptoms at week 1 and compared with the end of week 4.
Secondary	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.	The investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained