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SER-ABS-AUD: Neuropsychosocial-Spiritual Correlates of Serene Abstinence in Adults With AUD

Study acronym: SER-ABS-AUD
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 1, 2026 → Nov 1, 2026
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Grigore T. Popa University of Medicine and Pharmacy

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Primary completion pushed from Sep 1, 2026 to Nov 1, 2026
    • Eligibility criteria expanded, about 85 words
    • Secondary endpoints: 6 to 12
    • Study description expanded, about 286 words
    • Study title expanded, about 4 words
  2. Study site revised
    • Collaborators expanded, about 8 words
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
SER-ABS-AUD is a single-centre, non-interventional, mixed retrospective-prospective longitudinal cohort study of 70 adults aged 18-70 years with documented alcohol use disorder, at least 12 consecutive months of continuous alcohol abstinence before enrolment, and an archived pre-enrolment MCMI-IV profile. After written informed consent at the current T2 enrolment visit, archived T1 MCMI-IV data and eligible clinical information are extracted, and the MCMI-IV plus a supplementary recovery-outcome battery are administered prospectively at T2. The primary outcome is within-person change in prespecified MCMI-IV scales between archived T1 and current T2. The secondary exploratory Serene Abstinence Index combines change in MCMI-IV Persistent Depression with current T2 natural reward response, spiritual well-being, and quality of life. T2-only measures are interpreted as current outcomes or concurrent exploratory correlates, not longitudinal change. No experimental intervention or post-enrolment 12-month follow-up is included.
Trial Details
NCT Number NCT07561749
Lead Sponsor Grigore T. Popa University of Medicine and Pharmacy
Collaborators: Association of Alcoholics in Recovery Clubs Don Orione
Conditions
(from sponsor)		 Alcohol Use Disorder (AUD), Alcohol Abstinence
Related terms Alcohol Abstinence, Alcoholism
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov