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临床试验/NCT05924022
NCT05924022已完成1 期

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

Washington State University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年12月4日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Change in Adjective Rating Scale of Withdrawal (ARSW)

研究概览

简要总结

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).

详细描述

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.

Edited 11/23/24: An additional study arm was added to better address the question about the level of HBOT needed for effects. The new participant sample size of 36 was chosen based on power analysis guided by our 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. Participants will be randomized into one of three trial arms: (active arm of n = 12 in HBOT 100% oxygen and 2.0 ATA, partial active arm of n = 12 in HBOT 100% oxygen and 1.3 ATA, and sham arm of n = 12 in HBOT 21% oxygen and 1.3 ATA). All 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Partial pressure treatment

Active Comparator

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

干预措施: Hyperbaric Oxygen Treatment Partial Pressure (Combination Product)

Full treatment

Experimental

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

干预措施: Hyperbaric Oxygen Treatment Full (Combination Product)

Sham

Sham Comparator

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

干预措施: Hyperbaric Oxygen Treatment Sham (Combination Product)

结局指标

主要结局

Change in Adjective Rating Scale of Withdrawal (ARSW)

时间窗: 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. Score is summed from 16 items with a possible range of 0 to 144.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marian Wilson

Associate Professor

Washington State University

研究点 (1)

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