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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytisine | Experimental | Cytisine will be given as 1.5 mg tablet formulations for 25 days. The following treatment schedule will be followed:
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| Placebo | Placebo Comparator | Placebo will be given following the same schedule as the Cytisine Arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytisine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and type of adverse events | To assess the tolerability of cytisine | Total duration of trial (24 weeks) |
| Rate of retention in the trial: number of sessions completed for each participant and number ofparticipants who withdraw | To assess the tolerability of cytisine | Total duration of trial (24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Point-prevalence abstinence | 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). | Week 2 and week 4 |
| Repeated point-prevalence abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on anxiety. | Anxiety will be measured through the General Anxiety Disorder-7 (GAD-7) questionnaire. | Throughout study duration (24 weeks) |
| Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on mood. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Le Foll | The Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D000437 | Alcoholism |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| C004712 | cytisine |
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| Placebo | Other | A placebo identical in appearance to cytisine will be used |
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Point-prevalence abstinence at each consecutive assessment point. |
| Throughout study completion, up to 24 weeks. |
| Prolonged abstinence | Complete abstinence ("not even a puff") after an initial grace period; also known as sustained abstinence. | This period will end at the end of treatment (day 25) or at final follow-up. |
| Prolonged abstinence with lapses | 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). | This period will end at the end of treatment (day 25) or at final follow-up. |
| Continuous Abstinence | 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. | Throughout study completion, up to 24 weeks. |
| Physical dependence to Nicotine in Participants | The Fagerstrom Test for Nicotine Dependence (FTND) will be used to assess physical dependence in participants. | Throughout study duration (24 weeks) |
| Nicotine Withdrawal Symptoms in Participants | The Minnesota Nicotine Withdrawal Scale (MNWS) will be used to assess nicotine withdrawal symptoms. | Throughout study duration (24 weeks) |
| Nicotine Craving in Participants | Tiffany Questionnaire of Smoking Urges (QSU) will be used to assess nicotine craving. | Throughout study duration (24 weeks) |
Mood will be measured by the Patient Health Questionnaire-9 (PHQ-9). |
| Throughout study duration (24 weeks) |
| Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on Quality of Life. | Quality of Life will be measured through the WHO Disability Assessment Schedule (WHODAS). | Throughout study duration (24 weeks) |
| Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by collecting the number of drinking days in participants. | Number of drinking days and drinks per day/drinking day will be collected. | Throughout study duration (24 weeks) |
| Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of heavy drinking days in participants. | Percent of heavy drinking days (5+/4+ males/females)/very heavy drinking days (10+/8+ males/females) per week and per month will be collected. | Throughout study duration (24 weeks) |
| Tertiary Endpoints to evaluate the impact of cytisine vs. placebo on drinking by measuring the proportion of participants without heavy drinking days. | Percent of subjects who are abstinent, percent of subjects with no heavy drinking days and percent of days abstinent will be collected. | Throughout study duration (24 weeks) |
| D015438 | Health Behavior |
| D001519 | Behavior |