NCT07690423

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Jul 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Dec 2027

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 8, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 1, 2026

Last Update Submit

July 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • proportion of participants maintaining abstinence at M1

    From enrollment to the end of the treatment at 4 weeks

Study Arms (2)

Cognitive cycling group

EXPERIMENTAL

Participants in the experimental (cognitive cycling) group will receive, in addition to standard addiction care, 12 cognitive cycling sessions (three sessions per week over four weeks)

Other: cognitive cycling

Control phone group

NO INTERVENTION

The control phone group will receive standard care combined with 12 scheduled telephone interviews conducted in parallel with the cognitive cycling sessions

Interventions

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.

Cognitive cycling group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

July 8, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 10, 2026

Record last verified: 2026-07