Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorNu Eyne Co., Ltd.
About this trial
This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
Eligibility criteria
Qualifiers
Participants aged 19 to 80 years
Participants currently dependent on opioids, whether prescribed or non-prescribed
Participants who meet the criteria for opioid use disorder (OUD) according to DSM-5
Participants with a Clinical Opiate Withdrawal Scale (COWS) score of 5 or higher
Disqualifiers
Participants with any current uncontrolled or clinically significant medical condition
Participants with a history of seizures or epilepsy
Participants with a history of neurological disorders or traumatic brain injury
Participants who have used long-acting opioids, such as methadone or buprenorphine, continuously for more than 5 days prior to screening
Trial design
Treatments tested in this trial
- Neurostimulation
- Sham stimulation
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nu Eyne Co., Ltd.
Lead sponsor
C&R Research, Inc.
Collaborator
Source ClinicalTrials.gov