Cytisine for Smoking Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Tobacco Use Disorder Alcohol Use Disorder Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cytisine

Cytisine will be given as 1.5 mg tablet formulations for 25 days.

The following treatment schedule will be followed:

* Days 1 to 3: 1.5 mg taken every 2 hours (6 pills (9 mg)/day)
* Days 4 to 12: 1.5 mg taken every 2.5 hours (5 pills (7.5 mg)/day)
* Days 13 to 16: 1.5 mg taken every 3 hours (4 pills (6 mg)/day)
* Days 17 to 20: Taper down to 1 tablet every 5 hours (3 pills (4.5 mg)/day)
* Days 21 to 25: Taper down to 1-2 tablets daily (1.5-3 mg/day)

Group Type EXPERIMENTAL

Cytisine

Intervention Type 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.

Placebo

Placebo will be given following the same schedule as the Cytisine Arm.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A placebo identical in appearance to cytisine will be used

Interventions

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Cytisine

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.

Intervention Type DRUG

Placebo

A placebo identical in appearance to cytisine will be used

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No