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Alcohol Use Disorder (AUD)MBRPNCT04598399

Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

A study testing Mindfulness Based Relapse Prevention and Relaxation/ meditation in people with Alcohol Use Disorder (AUD), run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Use Disorder (AUD)
What is being tested?
Mindfulness Based Relapse Prevention and Relaxation/ meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
7 sitesFrance
Study dates
20 Oct 2021to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having a moderate to severe alcohol use disorder according to DSM 5 criteria.
  • The last drink must have been consumed at most in the last 60 days before the pre-inclusion visit. The patient must have had at least 1 HDD during the last drinking period

Who cannot join

  • Severe depression (Beck Depression Inventory> 30)
  • Schizophrenic disorder,
  • Current maniac or hypomaniac episode,
  • Patient with dementia or severe cognitive impairment that would prevent him/her from following the course of a session, as judged by the clinician.
  • Insufficient French understanding to complete the questionnaires
  • Pregnant or breastfeeding woman
Show all 9Show fewer
  • Absence of social security regimen
  • Other mindfulness-based structured therapies
  • Refusal to sign the written consent. • The patient is under safeguard of justice or state guardianship

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amandine Luquiens contact

04.66.68.69.98

Amandine.luquiens@chu-nimes.fr

7 sites in 1 country

France7 sites, 7 recruiting

  • Ssra Les Eumenides

    Angers, 49100

    CORINNE DANO, 0241353485, codano@chu-angers.fr

    Recruiting

  • Hôpital Corentin-Celton

    Issy-les-Moulineaux

    Patrice Louvillle, 01 58 00 44 25, patrice.louvillle@aphp.fr

    Patrice Louvillle

    Not yet recruiting

  • CHU de Nantes

    Nantes

    Marie Grall-Bronnec, 02.40.84.61.16, marie.bronnec@chu-nantes.fr

    Marie Grall-Bronnec

    Recruiting

  • CHU de Nimes

    Nîmes

    Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr

    Amandine Luquiens

    Recruiting

  • Hopital Fernand Widal

    Paris, 75010

    FLORENCE VORSPAN, 0141525676, florence.vorspan@aphp.fr

    Not yet recruiting

  • Hopital Des 4 Villes

    Sèvres, 92310

    NICOLAS THIERCELIN, 0177707940, n.thiercelin@ch4v.fr

    Not yet recruiting

  • Hopital Paul Brousse

    Villejuif

    Amine Benyamina, 01 45 59 69 78, secretariat.addictologie.pbr@aphp.fr

    Amine Benyamina

    Not yet recruiting

Other trials in France

About this study

Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.

Being tested
Mindfulness Based Relapse Prevention, Relaxation/ meditation
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness Based Relapse PreventionBehavioural

    7 x 60-120 minute sessions with different themes: Automatic pilot/triggers/relapse/high-risk situations/ mindfulness in daily life. There will be a welcoming time, with a focus on at-home practice and difficulties, a theoretical presentation of new concepts, practical meditation exercises and a debriefing.

  • Relaxation/ meditationBehavioural

    7 x 60-120 minute sessions each with a different sound from nature with unguided, closed relaxation group with a maximum of 12 participants

Study groups in NCT04598399
Study groupRoleWhat they receive
MBRP program:ExperimentalNot described
Receives: Behavioral: Mindfulness Based Relapse Prevention
Standard careActive comparatorNot described
Receives: Behavioral: Relaxation/ meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months.

    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

    Measured: 6 months

Secondary outcomes (40)

  1. Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 3 months between groups

    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

    Measured: 3 months

  2. Change in number of heavy drinking days (HDD) during the last 4 weeks, between the last drinking period at inclusion and 12 months between groups

    Alcohol Time Line Follow Back (TLFB) where a HDD = consummation of 4+ (for women) or 5+ (for men) drinks per day.

    Measured: 12 months

  3. Change in 4-week total alcohol consumption since baseline

    number of drinks (1 glass = 1 unit according to grams alcohol)

    Measured: 3 months

  4. Change in 4-week total alcohol consumption since baseline

    number of drinks (1 glass = 1 unit according to grams alcohol)

    Measured: 12 months

  5. Change in frequency of craving since baseline

    version F of craving experience questionnaire (CEQ-F)

    Measured: 3 months

  6. Change in frequency of craving since baseline

    version F of craving experience questionnaire (CEQ-F)

    Measured: 6 months

  7. Change in frequency of craving since baseline

    version F of craving experience questionnaire (CEQ-F)

    Measured: 12 months

  8. Change in strength of craving since baseline

    version S of craving experience questionnaire (CEQ-S)

    Measured: 3 months

  9. Change in strength of craving since baseline

    version S of craving experience questionnaire (CEQ-S)

    Measured: 6 months

  10. Change in strength of craving since baseline

    version S of craving experience questionnaire (CEQ-S)

    Measured: 12 months

  11. Anxiety at baseline

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

    Measured: Baseline

  12. Change in anxiety since baseline

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

    Measured: 3 months

  13. Change in anxiety since baseline

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

    Measured: 6 months

  14. Change in anxiety since baseline

    Beck Anxiety Inventory depression (BAI): 21-item self-assessment scale assessing anxiety

    Measured: 12 months

  15. Depression at baseline

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

    Measured: Baseline

  16. Change in depression since baseline

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

    Measured: 3 months

  17. Change in depression since baseline

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

    Measured: 6 months

  18. Change in depression since baseline

    Beck Depression Inventory (BDI): 21 items assessing the presence and severity of depressive symptoms

    Measured: 12 months

  19. Change in quality of life since baseline

    Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

    Measured: 3 months

  20. Change in quality of life since baseline

    Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

    Measured: 6 months

  21. Change in quality of life since baseline

    Alcohol Quality of Life Scale (AQoLS): 34-item patient-reported questionnaire

    Measured: 12 months

  22. Emotion regulation at baseline

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

    Measured: Baseline

  23. Change in emotion regulation since baseline

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

    Measured: 3 months

  24. Change in emotion regulation since baseline

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

    Measured: 6 months

  25. Change in emotion regulation since baseline

    Emotion Regulation Questionnaire (ERQ): 10-item scale designed to assessing Cognitive Reappraisal and Expressive Suppression on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree).

    Measured: 12 months

  26. Difficulties regulating emotion at baseline

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

    Measured: Baseline

  27. Changes in difficulties regulating emotion since baseline

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

    Measured: 3 months

  28. Changes in difficulties regulating emotion since baseline

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

    Measured: 6 months

  29. Changes in difficulties regulating emotion since baseline

    Difficulties in Emotion Regulation scale (DERS -Impulse): items 3, 14, 19, 24R, 27, 32 from DERS

    Measured: 12 months

  30. Changes in impulsivity since baseline

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

    Measured: 3 months

  31. Impulsivity at baseline

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

    Measured: Baseline

  32. Changes in impulsivity since baseline

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

    Measured: 6 months

  33. Changes in impulsivity since baseline

    Impulsive behavior scale (UPPS-P): 20-item self-assessment scale

    Measured: 12 months

  34. Changes in coping mechanism

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

    Measured: 3 months

  35. Coping mechanism at baseline

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

    Measured: Baseline

  36. Changes in coping mechanism

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

    Measured: 6 months

  37. Changes in coping mechanism

    brief COPE questionnaire: 14 scales including 2 items (28 items in total)

    Measured: 12 months

  38. Cognitive impairment

    Montreal Cognitive Assessment (MoCA)

    Measured: Baseline

  39. Initial mindfulness

    Five Facets Mindfulness Questionnaire (FFMQ): 39-item self-assessment tool measuring 5 factors of mindfulness

    Measured: Baseline

  40. Number of meditation sessions per week over the last 4 weeks

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start20 Oct 2021
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598399
Sponsor's protocol ID
PHRCN/2018/AL-01
Acronym
MBRP
Status last verified
Aug 2025
First submitted
16 Oct 2020
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Relapse Prevention and Relaxation/ meditation in people with Alcohol Use Disorder (AUD), run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amandine Luquiens (04.66.68.69.98, Amandine.luquiens@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in number of heavy drinking days (HDD) over previous 4 weeks, between the last drinking period at inclusion and 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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