Last updated: April 4, 2023
Sponsor: Centre for Addiction and Mental Health
Overall Status: Active - Recruiting
Phase
4
Condition
Alcohol Use Disorder
Alcohol Dependence
Addictions
Treatment
N/AClinical Study ID
NCT05729243
054-2022
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18-65 years;
- Have TUD assessed by structured clinical interview for DSM-5;
- Have past year AUD (active) assessed by structured clinical interview for DSM-5;
- Report daily cigarette consumption in past month and expired carbon monoxide (CO)measurement ≥10ppm at screening;
- Have Fagerstrom Test of Nicotine Dependence (FTND55) score ≥4;
- Have motivation to quit within 30 days i.e. Contemplation Ladder56 score ≥7;
- Be willing and able to comply with all study procedural and assessment demands;
- Be able to provide voluntary written informed consent.
Exclusion
Exclusion Criteria:
- Report prolonged smoking abstinence in the past month preceding screening;
- Be using other smoking cessation aids
- Enrolled in another smoking cessation program
- Be pregnant, breastfeeding, or intending to become pregnant or breastfeed;
- Exhibit suicidal thoughts or behavior in the past month;
- Enrolled in another study which would interfere with study procedures or represent apotential risk to the participant
- Have a serious unstable psychiatric or medical condition preventing participation inthe trial. This includes some forms of schizophrenia, ischemic heart disease, heartfailure, arterial hypertension (systolic BP above 150; diastolic BP above 100),cerebrovascular diseases, occlusion of blood vessels, kidney and/or liver disease,hyperthyroidism, ulcer, diabetes, Chromaffin tumours of the adrenal medulla, andgastroesophageal reflux disease (GERD)
Study Design
Total Participants: 48
Study Start date:
February 08, 2023
Estimated Completion Date:
June 30, 2024
Connect with a study center
Center for Addiction and Mental Health
Toronto, Ontario M5S 2S1
CanadaActive - Recruiting
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