Actively Recruiting
Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial
Led by Sir Mortimer B. Davis - Jewish General Hospital · Updated on 2025-04-29
798
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating aggressive smoking cessation therapy for adults at elevated cardiovascular risk who currently smoke at least 10 cigarettes daily and are motivated to quit. This 5-year, multi-center randomized controlled trial compares a combination of varenicline and nicotine e-cigarettes plus counseling to varenicline plus counseling alone. The study aims to determine which treatment better helps people stop smoking and reduces cigarette consumption, while assessing safety and side effects. Participants will be randomly assigned to one of two groups: one receiving varenicline alongside nicotine e-cigarettes and counseling, and the other receiving varenicline with counseling only for 12 weeks. Varenicline dosing starts low and increases to 1 mg twice daily, with adjustments if side effects occur. Those in the combination group receive funds to buy e-cigarettes and nicotine cartridges, with monitoring of use and receipts. Follow-up includes telephone calls and clinic visits up to 52 weeks. During the study, participants will report smoking habits, treatment adherence, and any adverse effects. Smoking cessation is confirmed with breath tests measuring carbon monoxide levels. Researchers will track smoking abstinence, reduction in cigarettes smoked, and safety outcomes. Clinic visits occur at weeks 4, 12, 24, and 52, with telephone follow-ups at weeks 1, 2, 8, and 18. The primary measure is smoking abstinence at 24 weeks, with continued monitoring through one year.
CONDITIONS
Brief Title
Aggressive Smoking Cessation Trial (ASAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Currently hospitalized or discharged patients with acute coronary syndrome (ACS) including myocardial infarction or unstable angina as defined by specific clinical criteria
- Outpatients with documented cardiovascular, renovascular, cerebrovascular, or peripheral vascular conditions, or at least one cardiovascular risk factor
- Smoked on average at least 10 conventional cigarettes per day for at least 1 year
- Motivated to quit smoking with a Motivation To Stop Scale score of 5 or higher
- Able to understand and provide informed consent in English or French
- Willing and able to purchase specific nicotine e-cigarettes if randomized to combination therapy
- Likely to be available for 52 weeks of follow-up
You will not qualify if you...
- Pregnant or lactating females
- Use of varenicline, bupropion, nicotine or non-nicotine e-cigarettes, or other anti-craving medications within specified time frames before eligibility assessment
- Use of nicotine replacement therapy within 7 days prior to eligibility assessment (with exceptions during hospitalization)
- Previous serious adverse reaction to varenicline or e-cigarettes
- New York Heart Association (NYHA) or Killip Class III or IV at randomization
- Any unstable psychiatric disorder
- Severe renal impairment with creatinine levels twice the upper limit or eGFR less than 15
- Use of illegal drugs in the past year
- Planned use of smoked cannabis or other smoked tobacco products during the study period (non-smoked cannabis allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants begin treatment with varenicline and receive smoking cessation counseling. Those in the combination therapy arm also use nicotine e-cigarettes with provided funds to support purchase of devices and cartridges. Treatment lasts 12 weeks with monitoring of medication use, e-cigarette use, and adverse effects.
Clinic visits at weeks 4 and 12; telephone follow-ups at weeks 1, 2, and 8
Duration - 40 weeks
Participants are followed for continued assessment of smoking abstinence, reduction in cigarette consumption, safety, and tolerability after treatment ends.
Clinic visits at weeks 24 and 52; telephone follow-up at week 18
Trial Site Locations
Total: 13 locations
1
Fraser Clinical Trials
New Westminster, British Columbia, Canada, V3L 3W4
Actively Recruiting
2
Dr. Georges-L.-Dumont University Hospital Center
Moncton, New Brunswick, Canada, E1C 2Z3
Actively Recruiting
3
NL Health Sciences
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
4
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
5
St. Joseph's Hospital
London, Ontario, Canada
Actively Recruiting
6
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
8
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
9
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
10
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
11
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
12
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
13
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
Research Team
T
Tabitha Finch
C
Carole Bohbot
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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