This study aims to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) applied to opioid withdrawal symptoms.
This study is a single-center, double-blind, randomized, sham-controlled, parallel-design exploratory clinical trial to evaluate the safety and efficacy of a physical device for medical use (ADTPM 1) in adults with opioid withdrawal symptoms. Eligible participants will be randomized to receive either active stimulation or sham stimulation applied to the auricular region daily for 60 minutes over a 4-week period. The primary objective is to assess the incidence of treatment-emergent adverse events. Secondary objectives include evaluating changes in opioid withdrawal severity, craving, pain, heart rate, depressive symptoms, anxiety, insomnia, somatic symptoms, and DSM-5 criteria for opioid use disorder over time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Participants in this group will use the physical device for medical use (ADTPM 1) applied to the auricular region (ear and surrounding area) for 60 minutes (±10 minutes) per session, at least once daily and a minimum of 7 times per week, over a 4-week treatment period. Additional sessions may be conducted if participants require further relief of withdrawal symptoms. All assessments and permitted concomitant treatments will be administered in accordance with the study protocol.
Control Group (Sham Stimulation, n=12): Participants in this group will use a sham stimulation device that does not deliver active stimulation. The sham device will be applied under the same schedule and conditions-60 minutes (±10 minutes) per session, at least once daily and 7 times per week for 4 weeks. All assessments and permitted concomitant treatments will be identical to those in the active stimulation group.
Kyungpook National University Hospital
Daegu, Daegu, South Korea
RECRUITINGIncidence of Treatment-Emergent Adverse Events (TEAEs)
The primary outcome is the incidence and severity of treatment-emergent adverse events (TEAEs) occurring from the first device application through the end of the 4-week treatment period. TEAEs include, but are not limited to, mild adverse events such as dizziness, somnolence, skin irritation, and headache. Safety will be assessed by monitoring vital signs, conducting physical examinations, and recording adverse events throughout the study period.
Time frame: [Time Frame: Baseline to Week 4]
Change in Clinical Opiate Withdrawal Scale (COWS) Scores
Change from baseline in COWS scores to assess the severity of opioid withdrawal symptoms over time. Higher scores indicate more severe withdrawal symptoms.
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Subjective Opiate Withdrawal Scale (SOWS) Scores
Change from baseline in SOWS scores to evaluate patient-reported withdrawal symptoms. Higher scores indicate more severe withdrawal symptoms.
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Opioid Craving Visual Analogue Scale (OC-VAS)
Change in opioid craving levels measured by a visual analogue scale. Higher scores indicate more severe craving.
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Heart Rate
Change in resting heart rate from baseline to assess physiological responses related to withdrawal. Higher heart rate may reflect increased autonomic arousal associated with withdrawal.
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
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Change in Numerical Rating Scale (NRS)
Change in self-reported pain severity measured by the NRS. Higher scores indicate greater pain intensity.
Time frame: [Time Frame: Baseline, 1 Hour, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
Change in depressive symptom severity from baseline. Higher scores indicate more severe depressive symptoms.
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores
Change in anxiety symptom severity from baseline. Higher scores indicate more severe anxiety symptoms.
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Insomnia Severity Index-Korean (ISI-K) Scores
Change in insomnia symptoms assessed by ISI-K. Higher scores indicate more severe insomnia symptoms.
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Patient Health Questionnaire-15 (PHQ-15) Scores
Change in somatic symptom severity over the treatment period. Higher scores indicate more severe somatic symptoms.
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in DSM-5 Criteria for Opioid Use Disorder
Change in diagnostic status of opioid use disorder as defined by DSM-5. Meeting more criteria indicates greater disorder severity
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]
Change in Opioid Craving Scale (OCS-3) Scores
Change in opioid craving symptoms measured by OCS-3. Higher scores indicate more severe craving.
Time frame: [Time Frame: Baseline, Day 2, Week 1, Week 2, Week 3, Week 4]