NCT06618755

Brief Summary

The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow :

  • Increase the percentage of days of abstinence in the year following withdrawal.
  • Reduce the rate of relapse in the year following withdrawal.
  • An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal.
  • A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal. All participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress53%
Dec 2024Jan 2028

First Submitted

Initial submission to the registry

September 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 18, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2028

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

3.1 years

First QC Date

September 24, 2024

Last Update Submit

June 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of days of abstinence over the 12 months following hospitalization for alcohol

    The measures used for our main criterion will be declarative and collected on paper and by telephone every month in terms of the number of drinks per day. To facilitate data collection, the Timeline Follow Back method \[30\], developed by Sobell and also validated by telephone, will be used. This tool enables estimates of daily consumption of standard glasses to be collected retrospectively (for up to 12 months). The advantage of this method is that it reduces recall bias, since the participant can fill in a calendar from day to day and the data are collected every month.

    From inclusion,once a month for 1 year

Secondary Outcomes (8)

  • Relapse rates at 5 and 12 months

    From inclusion,once a month for 1 year

  • Cumulative duration (in days) and maximum duration of abstinence over 5 and 12 months

    Assessed 5 months after inclusion and 12 months after inclusion

  • Motivation to maintain abstinence

    Assessed 0 month, 5 months and 12 months after inclusion

  • Craving felt

    Assessed 0 month, 5 months and 12 months after inclusion

  • Effectiveness of coping strategies

    Assessed 0 month, 5 months and 12 months after inclusion

  • +3 more secondary outcomes

Study Arms (2)

Experimental group : PSH (usual care) with motivational interviewing

EXPERIMENTAL

People randomised to the experimental group will have scheduled appointments to collect study data (monthly assessment). They will take part in an initial motivational interview to lay the foundations for the work that will be carried out throughout the follow-up period. Then, for 4 and a half months, a motivational interview will be scheduled every 14 days.

Other: Experimental group : PSH (usual care) with motivational interviewing

Control group : PSH (usual care)

NO INTERVENTION

People randomised to the control group will have scheduled appointments for study-related data collection (monthly assessment), in addition to their routine care.

Interventions

The experimental group will begin follow-up after the 1st inclusion visit, during hospitalisation for withdrawal. The first motivational interview will take place 1 to 4 days before discharge from full hospitalisation. The following 10 motivational interviews will be held 2 weeks apart and will follow a framework based on the following objectives: to create a relationship of trust and an effective and lasting therapeutic alliance from the first interview; to create personalised objectives for the user, in line with their addictive pathology; to support the user as they modify, 'fail' and 'succeed' in achieving these objectives; to encourage the emergence and maintenance of the user's desire to change.

Experimental group : PSH (usual care) with motivational interviewing

Eligibility Criteria

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

You may qualify if:

  • With alcohol use disorders defined by at least 2 DSM-V criteria for at least 12 months).
  • Being treated for withdrawal in hospital.
  • With a goal of complete abstinence.
  • With a means of communication (telephone).

You may not qualify if:

  • Lack of understanding (written and spoken) of the French language.
  • Breach of HC withdrawal contract, following failure to comply with the rules of the addictology service and somatic complications of addiction.
  • Eviction from the department, discharge against medical advice during hospitalisation for withdrawal.
  • Proven cognitive problems compromising understanding of the implications of the study and the proposed follow-up. proposed follow-up.
  • Serious decompensated somatic pathology.
  • Non-membership or non-beneficiaries of a national health insurance scheme.
  • Person protected by law, under guardianship or curatorship.
  • Not having signed free and informed consent to participate in the research.
  • Simultaneous participation in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas RISDORFER DE ISSDENTZI

Montpellier, 3400, France

RECRUITING

MeSH Terms

Conditions

AlcoholismBehavior, AddictiveRecurrence

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2024

First Posted

October 1, 2024

Study Start

December 18, 2024

Primary Completion (Estimated)

January 13, 2028

Study Completion (Estimated)

January 13, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations