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Could a Plant-Based pill help smokers with alcohol problems kick the habit?

NCT ID NCT05729243

Symptom relief Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether cytisine, a plant-based medication, is safe and helpful for quitting smoking in people who also have alcohol use disorder. Twenty adults who smoked daily and wanted to quit took part. The main goal was to see if the drug was well-tolerated and if participants stayed in the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Started

Feb 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

alcohol abuse nicotine dependence Smoking Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder Smoking cessation Tobacco use disorder

Contacts and locations

Locations

  • Center for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.