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Full treatment for Opioid Use Disorder
Phase 1
Recruiting
Led By Layton Matt, MD
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained
Awards & highlights
Study Summary
This trial aims to study if hyperbaric oxygen therapy (HBOT) is effective in reducing signs and symptoms of opioid withdrawal when compared to a sham treatment. The study also wants to see if HB
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of HBOT may include ear pressure changes, sinus pain, temporary vision changes, fatigue, headache or feeling lightheaded. These are generally mild and resolve after treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the investigators will capture clinical chart dose records at one month and three months from baseline to determine if change in methadone was sustained
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Adjective Rating Scale of Withdrawal (ARSW)
Secondary outcome measures
Change in Methadone dose
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Full treatmentExperimental Treatment1 Intervention
Participants are administered 100% oxygen in the HBOT chamber at 2.0 ATA
Group II: Partial treatmentPlacebo Group1 Intervention
Participants are administered 21% oxygen in the HBOT chamber at <1.3 ATA.
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Who is running the clinical trial?
Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,690 Total Patients Enrolled
Layton Matt, MDPrincipal InvestigatorWashington State University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential risks associated with undergoing a complete therapeutic regimen?
"Given the limited safety and efficacy data available for Full treatment, it has been rated a 1 on our scale. This corresponds to its Phase 1 trial status."
Answered by AI
What is the current number of participants being recruited for this medical study?
"Indeed, as per clinicaltrials.gov data, this trial is actively seeking volunteers. The initiative was initially listed on December 4th, 2023 and underwent its latest revision on February 4th, 2024. A total of 24 participants are sought after from a single designated site."
Answered by AI
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