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ClinicalTrials.gov Identifier: NCT05729243
Recruitment Status :
Recruiting

First Posted : February 15, 2023
Last Update Posted : April 6, 2023

Brief Summary:
The goal of this clinical trial is to evaluate the safety and effectiveness of cytisine as a smoking cessation treatment in individuals with concurrent alcohol use disorder.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder
Alcohol Use Disorder
Smoking Cessation
Drug: Cytisine
Other: Placebo
Phase 4

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 a potential risk to the participant
  • Have a serious unstable psychiatric or medical condition preventing participation in the trial. This includes some forms of schizophrenia, ischemic heart disease, heart failure, 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, and gastroesophageal reflux disease (GERD)

Source: http://classic.clinicaltrials.gov/ct2/show/NCT05729243?term=cytisine&rand=169