SER-ABS-AUD: Bio-Psycho-Socio-Spiritual Predictors of AUD Recovery
Romania70 participantsStarted 2026-04-20
Plain-language summary
Alcohol use disorder (AUD) remains a major public health burden in Romania, with very high alcohol-attributable mortality and years of life lost. Conventional treatment focuses on achieving abstinence, but the distinction between "struggle abstinence" (persistent cravings, anhedonia, white-knuckle willpower) and "serene abstinence" (anhedonia resolution, restored reward, meaning and quality of life) is poorly characterized in the Romanian context.
This longitudinal observational study uses the Millon Clinical Multiaxial Inventory-IV (MCMI-IV) together with a brief neuropsychosocial-spiritual battery to identify which personality patterns and clinical syndromes predict serene versus struggle abstinence in adults with DSM-5 alcohol use disorder who maintain at least 12 months of sobriety in Romanian community recovery settings.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of Alcohol Use Disorder according to DSM-5 or ICD-10 criteria documented in clinical records.
* Minimum 12 consecutive months of alcohol abstinence prior to baseline assessment (self-report corroborated by group leaders/clinical notes where available).
* Current or recent participation (last 12 months) in at least one recovery support program (ACAR support groups and/or Don Orione recovery services).
* Ability to understand study procedures and provide written informed consent in Romanian.
Exclusion Criteria:
* Acute psychiatric conditions requiring emergency intervention (e.g. psychotic episode, severe mania) at screening.
* Active suicidal risk (positive PHQ-9 item on suicidal ideation with associated clinical concern) requiring urgent care.
* Uncontrolled comorbid substance use disorder (e.g. ongoing illicit drug dependence) that would confound assessment of alcohol-related recovery.
* Legal incapacity or inability to provide informed consent.
* Severe cognitive impairment (e.g. MMSE below functional threshold) precluding valid questionnaire completion (to be screened where indicated).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serene Abstinence Index at 12 Months (Binary: Serene vs Struggle Abstinence)
Timeframe: 1 year
Trial details
NCT IDNCT07561749
SponsorGrigore T. Popa University of Medicine and Pharmacy