Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety (NCT05056753) | Clinical Trial Compass
CompletedNot Applicable
Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety
United States80 participantsStarted 2022-01-20
Plain-language summary
In this randomized, double-blind, controlled, parallel group study (conducted over 12-months), enrollment is expected of up to 60 subjects (30 men and 30 women) ages 18+ who are currently going through withdrawal of OUD and being treated at local substance abuse clinics. The study visits will include screening, baseline, Weeks 1, 2, 3, and 4, with both safety and efficacy assessments.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Minimum age of 18 (female and male)
* Confirmed diagnosis of opioid use disorder and deemed appropriate to participate in this study as referred by the medial director of a local outpatient treatment clinic for OUD
* Concurrent craving for drug
* In otherwise good physical health
* Access to a phone (communication device) and willingness to communicate with study staff
* Ability to understand and provide informed consent in English
Exclusion Criteria:
* Inability to provide verifiable contact information or unwillingness to assist with follow-up
* Unwilling to allow potential access to medical, drug treatment records or criminal history or criminal activity records that in the opinion of the site investigator would interfere with the conduct of the study
* History of violence or violent, erratic behavior that would indicate a risk to other participants, study staff or to the participant her/himself
* Psychoses, major depression, bipolar disorder, or other mental disorder that in the opinion of the site investigator, would interfere with the participant's ability to participate in the study
* A score of \> 2 on the Beck Depression Inventory-II (BDI-II) \[Suicidality\]
* A score of \< 6 on the Clinical Opiate Withdrawal Scale, which indicates mild opiate withdrawal symptoms
* Prior history of severe brain injury or seizures
* Prone to fainting
* Suffering from a recent injury from which they are still recovering or needing medications for recovery
* Not…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.