Opioid Use Disorder
Conditions
Brief summary
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).
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. 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.
Interventions
COMBINATION_PRODUCTHyperbaric Oxygen Treatment Full
Participants in this active treatment arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT)100% oxygen and 2.0 ATA 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.
COMBINATION_PRODUCTHyperbaric Oxygen Treatment Sham
Participants in the sham condition arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT) 21% oxygen and 1.3 ATA 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.
COMBINATION_PRODUCTHyperbaric Oxygen Treatment Partial Pressure
Participants in this partial treatment arm of the protocol will receive Hyperbaric Oxygen Treatment (HBOT)100% oxygen and 1.3 ATA 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.
Sponsors
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, 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.
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. Updated to 3 arms 11/23/24: Participants will be randomized into one of three trial arms: (active arm of n = 12 in HBOT 100% oxygen and 2.0 ATA, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. Score is summed from 16 items with a possible range of 0 to 144. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLayton Matt, MD
Washington State University
Outcome results
None listed