Alcohol Use Disorder, Smoking Cessation, Tobacco Use Disorder
Conditions
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.
Interventions
DRUGCytisine
Cytisine is a nicotinic acetylcholine receptor partial agonist and is a natural health product approved by Health Canada. Cytisine has been used for a long time in Europe for smoking cessation.
OTHERPlacebo
A placebo identical in appearance to cytisine will be used
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw | Total duration of trial (24 weeks) | To assess the tolerability of cytisine |
| Frequency and type of adverse events | Total duration of trial (24 weeks) | To assess the tolerability of cytisine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeated point-prevalence abstinence | Throughout study completion, up to 24 weeks. | Point-prevalence abstinence at each consecutive assessment point. |
| Prolonged abstinence | This period will end at the end of treatment (day 25) or at final follow-up. | Complete abstinence ("not even a puff") after an initial grace period; also known as sustained abstinence. |
| Prolonged abstinence with lapses | This period will end at the end of treatment (day 25) or at final follow-up. | Prolonged abstinence after a grace period, but some smoking is allowed (e.g., no more than 5 cigarettes; fewer than seven consecutive days of smoking). |
| Continuous Abstinence | Throughout study completion, up to 24 weeks. | Complete abstinence ("not even a puff") beginning on the TQD (i.e., with no grace period) and lasting until the assessment from target quit date (week 2) to end of treatment (day 25) and at final follow up. |
| Nicotine Withdrawal Symptoms in Participants | Throughout study duration (24 weeks) | The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms. |
| Physical dependence to Nicotine in Participants | Throughout study duration (24 weeks) | The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants. |
| Nicotine Craving in Participants | Throughout study duration (24 weeks) | Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving. |
| Point-prevalence abstinence | Week 2 and week 4 | Complete abstinence ("not even a puff") during a designated time period (7 days) prior to assessment. This will be measured at each assessment point (e.g., 2 and 4wk). |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORBernard Le Foll
The Centre for Addiction and Mental Health
Outcome results
None listed