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Nicotinic Acetylcholine Receptor Agonist
Cytisinicline for Smoking Cessation (Cytisinicline Trial)
Phase 2
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between the ages of 18 and 65 and provide informed consent
Be older than 18 years old
Must not have
Current suicidal ideation or lifetime history of suicide attempt
Current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment at 2-to-3 weeks
Summary
This trial will include 64 people who smoke daily but are not trying to quit smoking. They will be randomly assigned to different groups in a study testing the effects of cytisinicline on how the
Who is the study for?
This trial is for individuals aged 18-65 who smoke at least 10 cigarettes a day and are not looking to quit smoking. They must be willing to provide informed consent.
What is being tested?
The study is testing the effects of Cytisinicline, compared with a placebo, on brain responses to cigarette-related cues in daily smokers who aren't seeking treatment.
What are the potential side effects?
Potential side effects of Cytisinicline may include nausea, vomiting, sleep disturbances, and changes in taste perception.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old and can give informed consent.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have thoughts of harming myself or have attempted suicide in the past.
Select...
I am currently using a smoking cessation aid.
Select...
I have had a serious head injury or was unconscious for over 30 minutes.
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I weigh more than 250lbs.
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I am not currently using any psychoactive drugs, except for cannabis.
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I haven't had a serious illness like a heart attack or stroke in the last 3 months.
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My kidney function is good, with a creatinine clearance over 60 mL/min.
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My blood pressure is not higher than 160/100 mmHg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to end of treatment at 2-to-3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment at 2-to-3 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task
Secondary study objectives
In-scanner cigarette cue-induced subjective craving
Subjective cigarette craving during outpatient period
Side effects data
From 2021 Phase 3 trial • 810 Patients • NCT0457694910%
Insomnia
8%
Headache
8%
Abnormal dreams
6%
Anxiety
6%
Nausea
5%
Constipation
4%
Diarrhoea
3%
Back pain
3%
Fatigue
3%
COVID-19
3%
Urinary tract infection
3%
Weight increased
3%
Irritability
2%
Dry mouth
2%
Vomiting
2%
Dizziness
2%
Hypertension
1%
Depression
1%
Sinusitis
1%
Sleep disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
12 Week Cytisinicline + Behavioral Support
Placebo + Behavioral Support
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CytisiniclineExperimental Treatment1 Intervention
3mg cytisinicline oral capsule 3 times daily for 2-to-3 weeks
Group II: PlaceboPlacebo Group1 Intervention
matched to experimental drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytisinicline
2022
Completed Phase 3
~1660
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,567 Previous Clinical Trials
10,312,124 Total Patients Enrolled
9 Trials studying Tobacco Use Disorder
1,018 Patients Enrolled for Tobacco Use Disorder