Addiction & Stroke

NCT06187025 | Recruiting

• 1 other identifier: CHUBX 2022/56
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Modifiable stroke risk-factors, which include poor lifestyle habits, account for 90 % of the risk of stroke. Disability Adjusted Life Years (DALYs) related to cerebrovascular disorders rely on three main factors, including the severity of stroke-related symptoms, the occurrence of stroke complications, and stroke recurrences. Stroke complications and the risk of stroke recurrence are highly dependent on the control of vascular risk factors. Thus, the secondary prevention of stroke involves profound lifestyle modifications including substance use cessation and diet changes.

Conditions

Stroke

Keywords

Stroke; Transient Ischemic Attack; Substance Related and Addiction Disorders; Mood disorders; Anxiety Disorders; Secondary prevention

Outcome Measures

Primary Outcomes (35)

• Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

  8 questions covering tobacco, alcohol, cannabis, amphetamine type stimulants, inhalants, sedatives, hallucinogens, opiates and 'other drugs' (e.g. sugar, caffeine; fatty food items will be included). It begins by a screening item that asks about lifetime use. In case of a " No " answer, the evaluation terminates. When a " Yes " answer is provided, the remaining questions ask for the substances endorsed during the prior 3 months: 1) the frequency of use, 2) problems and usage patterns, 3) the compulsion to use (psychological dependence), 4) the domains of the problems (personal, health, financial, legal), 5) failure in meeting role obligations, 6) a screening of lifetime in addition to recent problems, 7) attempts at controlling substance use, and 8) current and lifetime injection of drugs (if appropriate). Twenty-eight domains/scores are derived from these questions

  Day 0

• Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

  8 questions covering tobacco, alcohol, cannabis, amphetamine type stimulants, inhalants, sedatives, hallucinogens, opiates and 'other drugs' (e.g. sugar, caffeine; fatty food items will be included). It begins by a screening item that asks about lifetime use. In case of a " No " answer, the evaluation terminates. When a " Yes " answer is provided, the remaining questions ask for the substances endorsed during the prior 3 months: 1) the frequency of use, 2) problems and usage patterns, 3) the compulsion to use (psychological dependence), 4) the domains of the problems (personal, health, financial, legal), 5) failure in meeting role obligations, 6) a screening of lifetime in addition to recent problems, 7) attempts at controlling substance use, and 8) current and lifetime injection of drugs (if appropriate). Twenty-eight domains/scores are derived from these questions

  12 Month

• Addiction Severity Index - Lite version (ASI)

  shortened version of the Addiction Severity Index (French version Denis et al., 2016). It covers areas that may be affected by addiction: medical status, employment/support status, drug and alcohol use, family and social relationships, legal and psychological status. It provides lifetime information as well as over the previous 30 days

  Day 0

• modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)

  abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (mYFAS 2.0; French version Brunault et al., 2020), which was designed specifically to assess signs of addictive-like eating behavior. It includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs with two questions to assess clinically significant distress and impairment. There are two scoring options: 1) a "symptom count" that reflects the number of addiction-like criteria endorsed and 2) a "diagnosis" when the participant endorses 2 or more symptom criteria plus clinically significant impairment or distress). FA is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress. It will be proposed either as a self-report or an interviewer-based questionnaire as decided by the psychologist

  Day 0

• modified Yale Food Addiction Scale 2.0 (mYFAS 2.0)

  abbreviated, 13-item version of the Yale Food Addiction Scale 2.0 (mYFAS 2.0; French version Brunault et al., 2020), which was designed specifically to assess signs of addictive-like eating behavior. It includes one question to assess each of the 11 DSM 5 diagnostic criteria for SRADs with two questions to assess clinically significant distress and impairment. There are two scoring options: 1) a "symptom count" that reflects the number of addiction-like criteria endorsed and 2) a "diagnosis" when the participant endorses 2 or more symptom criteria plus clinically significant impairment or distress). FA is mild if there are 2 or 3 symptoms and clinically significant impairment/distress, moderate if there are 4 or 5 symptoms and significant impairment/distress, and severe if there are 6 or more symptoms and significant impairment/distress. It will be proposed either as a self-report or an interviewer-based questionnaire as decided by the psychologist

  12 Month

• Fagerström Test for Nicotine Dependence (FTND) Score

  includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity

  Day 0

• Fagerström Test for Nicotine Dependence (FTND) Score

  includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity

  3 Month

• Fagerström Test for Nicotine Dependence (FTND) Score

  includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity

  6 Month

• Fagerström Test for Nicotine Dependence (FTND) Score

  includes 10 items. Scores can range from 0 to 10. The recommended cut-off scores to index the categories of nicotine dependence severity are as follows: below 2 = no dependence, 3 to 4 = mild severity, 5 to 6 = moderate severity, 7 to 10 = extreme severity

  12 Month

• Alcohol Use Disorder Identification Test (AUDIT) Score

  includes 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, above 12 = extreme severity for both sexes

  Day 0

• Alcohol Use Disorder Identification Test (AUDIT) Score

  includes 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, above 12 = extreme severity for both sexes

  3 Month

• Alcohol Use Disorder Identification Test (AUDIT) Score

  includes 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, above 12 = extreme severity for both sexes

  6 Month

• Alcohol Use Disorder Identification Test (AUDIT) Score

  includes 10 items. Scores can range from 0 to 40. The recommended cut-off scores to index the categories of alcohol dependence severity are as follows: from 6 to 12 for women and 7 to 12 for men = moderate severity, above 12 = extreme severity for both sexes

  12 Month

• Cannabis Abuse Screening Test (CAST) Score

  includes 6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, 3 or more = high risk of dependence

  Day 0

• Cannabis Abuse Screening Test (CAST) Score

  includes 6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, 3 or more = high risk of dependence

  3 Month

• Cannabis Abuse Screening Test (CAST) Score

  includes 6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, 3 or more = high risk of dependence

  6 Month

• Cannabis Abuse Screening Test (CAST) Score

  includes 6 items. Scores can range from 0 to 6. The recommended cut-off scores to index the categories of cannabis dependence severity are as follows: below 2 = low risk of dependence, a score of 2 = moderate risk of dependence, 3 or more = high risk of dependence

  12 Month

• Readiness Ruler or Substance Use Motivation Ruler Score

  asks the respondent to rank his/her motivation to end his/her substance use on a VAS scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations

  Day 0

• Readiness Ruler or Substance Use Motivation Ruler Score

  asks the respondent to rank his/her motivation to end his/her substance use on a VAS scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations

  3 Month

• Readiness Ruler or Substance Use Motivation Ruler Score

  asks the respondent to rank his/her motivation to end his/her substance use on a VAS scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations

  6 Month

• Readiness Ruler or Substance Use Motivation Ruler Score

  asks the respondent to rank his/her motivation to end his/her substance use on a VAS scale from 1 (Absolutely no motivation to quit) to 10 (No doubt about the decision to be sober) and to list some motivations

  12 Month

• Multidimensional Assessment of Thymic States scale (MAThYS)

  evaluation of a broad spectrum of mixed mood states. It is based on the concept that mood can be defined using emotional reactivity and not only tonality of affects. It consists in a visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped in five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. motivation and 5. sensory perception.

  Day 0

• Multidimensional Assessment of Thymic States scale (MAThYS)

  evaluation of a broad spectrum of mixed mood states. It is based on the concept that mood can be defined using emotional reactivity and not only tonality of affects. It consists in a visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped in five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. motivation and 5. sensory perception.

  3 Month

• Multidimensional Assessment of Thymic States scale (MAThYS)

  evaluation of a broad spectrum of mixed mood states. It is based on the concept that mood can be defined using emotional reactivity and not only tonality of affects. It consists in a visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped in five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. motivation and 5. sensory perception.

  6 Month

• Multidimensional Assessment of Thymic States scale (MAThYS)

  evaluation of a broad spectrum of mixed mood states. It is based on the concept that mood can be defined using emotional reactivity and not only tonality of affects. It consists in a visual analog scale of 20 items relating to individual states as perceived by the patient for the preceding week. Items can be grouped in five quantitative dimensions ranging each from inhibition to excitation: 1. emotional reactivity, 2. thought processes, 3. psychomotor function, 4. motivation and 5. sensory perception.

  12 Month

• Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score

  standardized instrument that has been developed to quickly evaluate post-stroke cognitive, emotional and behavioral complaints. It includes 13 cognitive items, 9 emotional items and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. Scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).

  Day 0

• Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score

  standardized instrument that has been developed to quickly evaluate post-stroke cognitive, emotional and behavioral complaints. It includes 13 cognitive items, 9 emotional items and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. Scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).

  3 Month

• Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score

  standardized instrument that has been developed to quickly evaluate post-stroke cognitive, emotional and behavioral complaints. It includes 13 cognitive items, 9 emotional items and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. Scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).

  6 Month

• Checklist for Cognitive and Emotional Consequences following stroke (CLCE-24) Score

  standardized instrument that has been developed to quickly evaluate post-stroke cognitive, emotional and behavioral complaints. It includes 13 cognitive items, 9 emotional items and 2 additional open-ended, non-specified items concerning potential additional difficulties not evaluated by the other items. Scoring of each item ranges from 0 (not present) to 3 (present and affecting daily life).

  12 Month

• EuroQoL 5-Dimensions Questionnaire (EQ-5D)

  standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients (Chen et al., 2016). This questionnaire has been used in several stroke studies and is currently the primary outcome measure of the Stroke and Carer Optimal Health Program trial

  3 Month

• EuroQoL 5-Dimensions Questionnaire (EQ-5D)

  standardized instrument for use as a measure of health outcome in stroke and was designed for self-completion by respondents. The 5 items of the questionnaire provide a simple descriptive profile and a single index value for health status. The EQ-Index has shown reasonable validity and acceptable responsiveness for detecting the health-related quality of life in stroke patients (Chen et al., 2016). This questionnaire has been used in several stroke studies and is currently the primary outcome measure of the Stroke and Carer Optimal Health Program trial

  6 Month

• Stroke Risk

  The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction

  Day 0

• Stroke Risk

  The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction

  3 Month

• Stroke Risk

  The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction

  6 Month

• Stroke Risk

  The Stroke Riskometer app assesses the possibility of suffering a stroke using a number of health and lifestyle factors including age, sex, ethnic origin, blood pressure, atrial fibrillation, left ventricular hypertrophy, anti-hypertension, tobacco, cardiovascular history, weight / height ratio, cholesterol level, diabetes, alcohol, stress, cognitive decline, family and personal history of stroke and TIA, history of head trauma and myocardial infarction

  12 Month

Study Arms (1)

Standardized clinical evaluations, and screening of substance use

OTHER

Standardized clinical evaluations, and screening of substance use will be performed for all using the World Health Organization Alcohol, Smoking and Drug Abuse Screening Test (ASSIST).

Other: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST); Other: Ecological Momentary Assessment (EMA)

Interventions

Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) OTHER

Standardized clinical evaluations and screening of substance use using the World Health Organization Alcohol, Smoking and Drug Abuse Screening Test (ASSIST)

Standardized clinical evaluations, and screening of substance use

Ecological Momentary Assessment (EMA) OTHER

Daily EMA evaluations during 12 weeks

Standardized clinical evaluations, and screening of substance use

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• At least 18 years of age and younger than 80 years;
• Recent (≤ 15 days) clinically symptomatic ischemic or hemorrhagic stroke documented through brain imaging (CT or MRI) or a Transient Ischemic Attack with an ABCD2 score ≥ 4;
• Returning to the Bordeaux Hospital neurovascular unit for the standard care 3-months post-stroke follow-up visit;
• National Institute Health Stroke Scale (NIHSS) \< 15;
• modified Rankin scale ≤ 4;
• No severe cognitive impairment as defined by the neurologist;
• Written informed consent by the patient;
• Coverage by the French National Health Insurance.

You may not qualify if:

• Subarachnoid hemorrhage; Dementia syndrome or other neurologic disorder;
• Severe aphasia (NIHSS item 9 ≥ 2) and/or Severe visual impairment interfering with the completion of evaluations;
• Severely impaired physical and/or mental health that, according to the neurologist, may affect the participant's capacity to participate in the study;
• Pregnancy or breastfeeding;
• Inability to read French;
• Individuals under legal protection or unable to personally express their consent
• Participation in another protocol modifying the patient's follow-up status

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Mood Disorders; Anxiety Disorders

Interventions

Ethanol; Smoking Devices; Insemination, Artificial, Heterologous; Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Manufactured Materials; Technology, Industry, and Agriculture; Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Igor Sibon

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Sylvie Berthoz

  CNRS UMR 5287 - INCIA

  STUDY DIRECTOR

Central Study Contacts

Igor Sibon

CONTACT

05 56 79 55 20; igor.sibon@chu-bordeaux.fr

Sylvie Berthoz

CONTACT

06.76.29.16.41; sylvie.berthoz-landron@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: February 7, 2024
• Primary Completion (Estimated): August 7, 2026
• Study Completion (Estimated): August 7, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)