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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04881500
Other study ID # 29BRC20.0261
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 11, 2022
Est. completion date March 7, 2024

Study information

Verified date March 2024
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 83
Est. completion date March 7, 2024
Est. primary completion date March 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motivational interview
Patients will follow motivational interview (2 individual sessions by phone)
Routine Care
Patients will follow routine care

Locations

Country Name City State
France Guillou Landreat Brest
France SIMSON Jean-Pierre Brest
France LE GOFF Delphine Landerneau
France ROZEC Pascale Landerneau
France LE RESTE Jean-Yves Lanmeur
France BARAIS Marie Lannilis
France SIMON Catherine Morlaix

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability of patients to control their own alcohol consumption The primary outcome is the perceived ability of patients to control their own alcohol consumption measured on a visual analogue scale from 0 to 100 in relation to the question "How much do you estimate your ability to control your alcohol consumption?" with 0 = no ability to control my drinking and 100 = all my ability to control my drinking. This primary outcome is evaluated at 3 month. Day 0 to Month 6
Secondary Evaluation of quality of life The quality of life will be evaluated by AQoLS scale whose is a specific quality of life scale to alcohol use disorders. It measures the negative impact of the relationship with alcohol on quality of life through 7 dimensions (Relationships with others, Activities, Negative emotions, Self-esteem, Loss of control, Sleep, Living conditions). Each item corresponds to a score from 0 (not at all) to 3 (very much), the total score being the sum of the 34 items in this self-questionnaire. There is no threshold value, as the patient is his or her own control in his or her own evolution. Day 0, Month 1, Month 3 and Month 6
Secondary Severity of alcohol use disorders Severity of alcohol use disorders at each visit, as measured by the AUDIT ( (Alcohol Use Disorders Identification Test) score.
AUDIT (Alcohol Use Disorders Identification Test) score is a 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 8 or more is considered to indicate hazardous or harmful alcohol use.
Day 0, Month 1, Month 3 and Month 6
Secondary Evaluation of severity of alcohol use disorders Severity of alcohol use disorders at each visit, as measured by the number of DSM5 (Diagnostic and Statistical manual of Mental disorders 5) criteria. The DSM5 score is diagnosis of addiction is based on well-defined criteria set out in the Diagnostic and Statistical manual of Mental disorders (DSM), the fifth edition of which was published in 2013. The questionnaire consists of 11 items (diagnostic criteria for substance use disorders from the American Psychiatric Association's DSM V). The presence of 2 to 3 criteria: low addiction / Presence of 4 to 5 criteria: moderate addiction / Presence of 6 or more criteria: severe addiction. Day 0, Month 1, Month 3 and Month 6
Secondary Limitation of alcohol consumption Ability to implement limiting strategies, as measured by the visual analogue scale from 0 to 100 on the question "How well do you feel you are able to implement strategies to limit/restrict (or avoid) your alcohol consumption" at each visit? Day 0, Month 1, Month 3 and Month 6
Secondary Evaluation of alcohol use Alcohol consumption measured by the Alcohol Timeline Followback (ATLFB) score at each visit. The ATLFB (Alcohol Timeline FollowBack) is a method for assessing recent drinking behavior. It involves asking clients to retrospectively estimate their daily alcohol consumption over a time period for 30 days prior to the interview. This scale is just an estimate of alcohol consumption on 1 month, there are no minimum or maximum values and so no better or worse outcome. Day 0, Month 1, Month 3 and Month 6
Secondary Craving assessment The Obsessive Compulsive Drinking Scale (OCDS) is a 14-item questionnaire that measures an individual's alcohol use and his/her attempts to control his/her drinking (each item is scored on a scale from 0 to 4). Obsessive subscale is the summation of items 1-6 / Compulsive subscale is the summation of items 7-14. Day 0, Month 1, Month 3 and Month 6
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