Clinical trial NCT04881500: Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology) (DEPREV_Phase 3)
Official title: Impact of a Brief Motivational Intervention Including Counter-marketing Arguments With a Population of Patients With Moderate to Severe Alcohol Use Disorders Who Are Followed up on an Outpatient Basis (Primary Care or Addictology)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Addiction, Alcohol
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Alcohol consumption is the second cause of avoidable death after tobacco. The Evin law was constructed in 1991 with the aim of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Alcohol Society is alarmed by these developments.

Studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. But beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. Alcohol consumption is one of the very first causes of hospitalization in France. The damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders. This population is, however, the target of manufacturers, since 10% of the French population consumes 58% of the alcohol sold in France. Moreover, although in the context of tobacco, counter-marketing campaigns and strategies are used to help users develop resistance to the positive marketing stimuli of alcohol, there are no studies that have evaluated this type of intervention with patients with moderate to severe alcohol use disorders.

The DEPREV_phase 3 study is a prospective, controlled, randomised, open-label study.

Patients followed in the primary care network participating in the study and those followed in the addictology network of northern Finistère in the context of their pathology will be offered the opportunity to participate in the study.

Patients agreeing to participate will be randomized in 2 groups (1:1) by the addictology unit:

* Control group: routine routine follow-up (follow-up in consultations with the attending physician or addictologist) + assessments at Month 1, Month 3 and Month 6.
* Intervention group: Routine routine follow-up (follow-up in consultation with the attending physician or addictologist) + assessments at Month 1, Month 3 and Month 6 + motivational interview (2 individual sessions, during the first month after inclusion).

Patients will then be followed up and evaluated at 1, 3 and 6 months after the inclusion visit.


Eligibility criteria: Inclusion Criteria :

- Patient over 18 years of age

* Current alcohol consumption (several times a month)
* Compliance with the criteria for harmful use or dependence according to AUDIT scale greater than or equal to 7 for men or 6 for women
* Outpatient follow-up in primary care or in addictology in the addictology network of northern Finistère

Exclusion Criteria :

* Patient under 18 years of age
* Subject under legal protection, guardianship, or curatorship or deprived of liberty
* Non comprehension of the French language
* Acute unstable psychiatric disorders affecting judgment
* No fixed or cell phone line
* AUDIT score less than 6 for women and 7 for men
* Addictology hospitalization history in the last 12 months

Primary outcomes:
measure: Ability of patients to control their own alcohol consumption
timeFrame: Day 0 to Month 6
Secondary outcomes:
measure: Evaluation of quality of life
timeFrame: Day 0, Month 1, Month 3 and Month 6
measure: Severity of alcohol use disorders
timeFrame: Day 0, Month 1, Month 3 and Month 6
measure: Evaluation of severity of alcohol use disorders
timeFrame: Day 0, Month 1, Month 3 and Month 6
measure: Limitation of alcohol consumption
timeFrame: Day 0, Month 1, Month 3 and Month 6
measure: Evaluation of alcohol use
timeFrame: Day 0, Month 1, Month 3 and Month 6
measure: Craving assessment
timeFrame: Day 0, Month 1, Month 3 and Month 6
Other outcomes:
Locations:
city: Brest
country: France
facility: Guillou Landreat
city: Brest
country: France
facility: SIMSON Jean-Pierre
city: Landerneau
country: France
facility: LE GOFF Delphine
city: Landerneau
country: France
facility: ROZEC Pascale
city: Lanmeur
country: France
facility: LE RESTE Jean-Yves
city: Lannilis
country: France
facility: BARAIS Marie
Study officials:
References: