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Addiction, AlcoholNCT04881500

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)

A study testing Motivational interview and Routine Care in people with Addiction, Alcohol, run by University Hospital, Brest at 6 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Addiction, Alcohol
What is being tested?
Motivational interview and Routine Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
6 sitesFrance
Study dates
11 Jan 2022to 7 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Guillou Landreat

    Brest

  • SIMSON Jean-Pierre

    Brest

  • LE GOFF Delphine

    Landerneau

  • ROZEC Pascale

    Landerneau

  • LE RESTE Jean-Yves

    Lanmeur

  • BARAIS Marie

    Lannilis

Other trials in France

About this study

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)

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.

Read more

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.

Being tested
Motivational interview, Routine Care
Medical subject headings
Alcoholism

What participants receive

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

  • Motivational interviewOther

    Patients will follow motivational interview (2 individual sessions by phone)

  • Routine CareOther

    Patients will follow routine care

Study groups in NCT04881500
Study groupRoleWhat they receive
Motivational interviewExperimentalPatients 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. If the patient was randomized to the intervention group, the patient will receive 2 individual sessions (motivational interview) by telephone within 1 month of inclusion. They will then be assessed at month 1, month 3 and month 6. These assessments will be done by telephone.
Receives: Other: Motivational interview
Routine CareActive comparatorPatients 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. If the patient has been randomized to the control group, the patient will be assessed at month 1, month 3 and month 6. These assessments will be done by telephone.
Receives: Other: Routine Care

What is being measured

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

  1. 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.

    Measured: Day 0 to Month 6

Secondary outcomes (6)

  1. 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.

    Measured: Day 0, Month 1, Month 3 and Month 6

  2. 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.

    Measured: Day 0, Month 1, Month 3 and Month 6

  3. 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.

    Measured: Day 0, Month 1, Month 3 and Month 6

  4. 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?

    Measured: Day 0, Month 1, Month 3 and Month 6

  5. 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.

    Measured: Day 0, Month 1, Month 3 and Month 6

  6. 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.

    Measured: Day 0, Month 1, Month 3 and 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 posted11 May 2021
  2. Study start11 Jan 2022
  3. Primary completion7 Mar 2024
  4. Study completion7 Mar 2024

Why it stopped: Recruiting difficulties

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04881500
Sponsor's protocol ID
29BRC20.0261
Status last verified
Jul 2024
First submitted
3 May 2021
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interview and Routine Care in people with Addiction, Alcohol, run by University Hospital, Brest at 6 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

The study was stopped early (reason given: Recruiting difficulties). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability of patients to control their own alcohol consumption (time frame: Day 0 to Month 6). 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 NCT04881500.

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 23 Jul 2024.

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