NCT04598399 Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder
| NCT ID | NCT04598399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2021-10-20 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2021-10-20 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Amandine Luquiens
PRINCIPAL INVESTIGATOR
CHU Nimes
Frequently Asked Questions
Who can join the NCT04598399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04598399 currently recruiting?
Yes, NCT04598399 is actively recruiting participants. Contact the research team at Amandine.luquiens@chu-nimes.fr for enrollment information.
Where is the NCT04598399 trial being conducted?
This trial is being conducted at Angers, France, Issy-les-Moulineaux, France, Nantes, France, Nîmes, France and 3 additional locations.
Who is sponsoring the NCT04598399 clinical trial?
NCT04598399 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Amandine Luquiens at CHU Nimes. The trial plans to enroll 168 participants.