Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07281261 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

tAN for Substance Use Disorder

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 31, 2026 → Aug 31, 2027
See other at-risk trials from Spark Biomedical, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 31, 2026 to Aug 31, 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Eligibility criteria revisedv5
  3. Recruitment opened
    • Start date changed from estimate of Jan 31, 2026 to Jan 28, 2026
    • Site details revised
    v4
  4. Start date: Jan 15, 2026 to Jan 31, 2026v3
  5. Site contact updated
    • Eligibility criteria shortened, about 1 word
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
Trial Details
NCT Number NCT07281261
Lead Sponsor Spark Biomedical, Inc.
Collaborators: The Menninger Clinic, Baylor College of Medicine, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State
Related terms Alcoholism, Substance-Related Disorders
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov