Menu
Not yet recruiting NCT07690423

Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal

No phase Interventional Cognitive Cycling Alcohol Use Disorder (AUD) Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cognitive cycling.
Who it may be relevant to
Registry conditions: Cognitive Cycling, Alcohol Use Disorder (AUD), Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal: Protocol for the TUA-VelCo Randomised Controlled Trial

Overview

TUA-VelCo is a single-center randomized controlled superiority trial with blinded methodological assessment. Adult patients hospitalized for alcohol withdrawal and meeting the criteria for Alcohol Use Disorder (AUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition will be eligible for inclusion. Participants will be randomly assigned to either a cognitive cycling intervention group or a control group. Participants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks). The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions. Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge. The primary outcome will be the proportion of participants maintaining abstinence at M1. Secondary outcomes include maintenance of abstinence at M3 and within-group and between-group changes in craving, cognitive functioning, insight, psychiatric symptoms, and motivation to maintain abstinent. These outcomes will be assessed using validated scales, including the Obsessive Compulsive Drinking Scale, Montreal Cognitive Assessment, Hanil Alcohol Insight Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale. Biomarkers related to alcohol consumption and neuroplasticity will also be evaluated.

Interventions

  • Other cognitive cycling
    Participants in the experimental group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks). The control group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions. Assessments will be conducted at baseline, 1 month (M1), and 3 months (M3) following hospital discharge.

Primary outcome measures

  • proportion of participants maintaining abstinence at M1 [Time frame: From enrollment to the end of the treatment at 4 weeks]

Eligibility criteria

Inclusion criteria

  • adults aged ≥ 18 years
  • patients with a diagnosis of alcohol use disorder (AUD) according to DSM-5 criteria
  • who have been hospitalized for complex withdrawal and aim to maintain abstinence after discharge
  • patients must have preserved cognitive function, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 26
  • patients must provide written informed consent

Exclusion criteria

  • pregnant women
  • patients with unstable psychiatric or somatic conditions
  • with a contraindication to physical activity
  • participants in structured rehabilitation programs during the first month
  • adult under guardianship
  • with inability to understand French or provide informed consent
  • with major neurocognitive disorder
  • with regular physical activity
  • participation in another interventional study interfering with outcomes

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07690423 · 2025-A01438-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗