The goal of this clinical trial is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol in firefighters who engage in heavy drinking, have at least a mild alcohol use disorder, and report above-average posttraumatic stress symptoms (PTS).
The main questions it aims to answer are:
* How feasible do firefighter participants rate the study procedures on the Feasibility of Intervention Measure? * How do firefighter participants rate the acceptability of the study procedures (Acceptability of Intervention Measure) and the appropriateness of the tAN device (Intervention Appropriateness Measure)?
Researchers will compare an active tAN condition (receiving therapeutic stimulation from the Sparrow device) to an active sham condition (receiving stimulation below a therapeutic level) to see if the intervention reduces PTS symptom severity and heavy drinking events, and to evaluate the clinical effects on insomnia, mental health symptoms, and quality of life.
Participants will:
* Use the Sparrow device for at least 1 hour/day for 5 days/week throughout a 4-week treatment phase. * Complete daily measures of traumatic event exposure, PTS symptom severity, alcohol use, and trauma-related drinking motivations. * Complete audio journals capturing their experience with symptoms and the device. * Wear sensors to record heart rate, heart rate variability, and sleep data throughout the intervention phase.
Complete assessments immediately following treatment (Week 4) and one month later (Week 8).
Active-duty firefighter aged 18 to 64 years old.
Endorse at least one heavy drinking event within the past month based on sex-assigned-at-birth thresholds (males: 5+ standard drinks on a single day and/or 15+ over 7 days; females: 4+ standard drinks on a single day and/or 8+ over 7 days).
Meet DSM-5 criteria for mild, moderate, or severe alcohol use disorder. Report at least moderate posttraumatic stress (PTS) symptoms, defined as a PTSD Checklist for DSM-5 (PCL-5) score of 20 or greater.
Willing to attend research visits, complete EMA measurements, use the study device, and provide informed consent in English.
Currently engaged in evidence-based PTSD psychotherapy or AUD-focused counseling at the time of randomization, or has experienced a past-month change in PTSD- or AUD-relevant medication.
High risk for moderate to severe alcohol withdrawal syndrome, indicated by a Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score of 4 or greater.
Unmedicated psychotic disorder or unmedicated bipolar disorder with a manic episode in the past month.
History of epileptic seizures, neurological diseases, or traumatic brain injury with lasting effects.
Parallel
Transcutaneous auricular neurostimulation (tAN)
DeviceThe research version of Spark's Sparrow Ascent for vagus and trigeminal nerve stimulation provided through a disposable earpiece that attaches to the ear. The device allows the participant to self-administer stimulation when they choose.
Active Sham
DeviceSame research device as the active tAN condition, but programmed with active sham parameters such that the stimulation is sufficient to be felt on the skin, but subtherapeutic.
Protocol Feasibility as Assessed by the Feasibility of Intervention Measure (FIM)
The FIM is a 4-item self-report questionnaire assessing the extent to which participants agree that the study protocol is feasible to implement. Items are rated on a 5-point Likert scale ranging from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are calculated as an average across items (ranging from 1 to 5), with higher scores indicating greater feasibility. Feasibility success is predefined as a mean score of at least 4.
Protocol Acceptability as Assessed by the Acceptability of Intervention Measure (AIM)
The AIM is a 4-item self-report questionnaire evaluating the degree to which participants perceive the study protocol to be acceptable. Items are rated on a 5-point Likert scale from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are averaged across items (range: 1 to 5), where higher scores indicate greater acceptability (benchmark: mean at least 4).
Device Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM)
The IAM is a 4-item self-report questionnaire assessing the perceived fit, relevance, and suitability of the Sparrow device for this population. Items are rated on a 5-point Likert scale from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are averaged across items (range: 1 to 5), with higher scores reflecting greater appropriateness (benchmark: mean at least 4).
Protocol Feasibility: Participant Retention Rate
Calculated as the percentage of randomized participants who complete the study through the Week 4 assessment. A study dropout rate \> 30% will indicate the need for protocol modification.
Protocol Feasibility: Sparrow Device Adherence Rate
Calculated as the percentage of participants who adhere to the minimum required stimulation dosage (at least 1 hour/day, 5 days/week) for at least 75% of the 4-week active treatment period, measured via automated device usage logs. The feasibility benchmark is achieved if at least 80% of participants meet this threshold.
Posttraumatic Stress Disorder Symptom Severity (PCL-5)
Mean pre-post change in PTSD Checklist for DSM-5 (PCL-5) total scores, as well as the proportion of participants achieving clinically meaningful symptom reduction (at least 30% reduction from baseline). The PCL-5 comprises 20 items rated from 0 ("Not at all") to 4 ("Extremely"), yielding total symptom severity scores from 0 to 80, where lower scores indicate lower PTS symptom severity.
Heavy Drinking Events
Change in the frequency of heavy drinking events using sex-assigned-at-birth thresholds (defined as 5+ standard drinks/day or 15+ drinks/week for males; 4+ drinks/day or 8+ drinks/week for females), measured via the Timeline Follow-back (TLFB). Also evaluated as the percentage of participants achieving a clinically meaningful reduction (50% or greater reduction in heavy drinking events).
Clinician-Assessed PTSD Severity (CAPS-5)
Evaluated using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), measuring past-week PTSD diagnostic status and continuous symptom severity, where lower scores indicate reduced symptom severity.
Insomnia Symptom Severity (ISI)
Total scores on the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms. Scores range from 0 to 28, with lower scores indicating less severe insomnia.
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University of Cincinnati
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
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