Actively Recruiting
Aggressive Smoking Cessation Trial (ASAP)
Led by Sir Mortimer B. Davis - Jewish General Hospital · Updated on 2025-04-29
798
Participants Needed
13
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The ASAP Trial is a 5-year, multi-centre, randomized controlled trial that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. It will recruit 798 adult patients smoking on average at least 10 conventional (tobacco) cigarettes per day who are motivated to quit smoking and have either been diagnosed with ACS requiring hospitalization or are outpatients at elevated cardiovascular risk. Patients will be randomized (1:1) to one of two treatment arms: (1) combination therapy of varenicline and nicotine e-cigarettes plus counseling or (2) varenicline plus counseling for 12 weeks, with 52-week follow-up.
CONDITIONS
Official Title
Aggressive Smoking Cessation Trial (ASAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized or discharged after acute coronary syndrome (ACS), including myocardial infarction or unstable angina, confirmed by specific clinical and diagnostic criteria
- Outpatients with cardiovascular, renovascular, cerebrovascular, or peripheral vascular disease or at least one cardiovascular risk factor
- Currently smoking at least 10 conventional cigarettes per day for at least one year
- Age 18 years or older
- Motivated to quit smoking with a Motivation To Stop Scale (MTSS) score of 5 or higher
- Able to understand and provide informed consent in English or French
- Willing and able to purchase specific types of e-cigarettes if randomized to the combination therapy arm
- 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 30 days before eligibility assessment
- Use of nicotine replacement therapy within 7 days before eligibility assessment (except as allowed during hospitalization)
- Use of varenicline or e-cigarettes for 14 or more consecutive days in the past year
- Previous serious adverse reaction to varenicline or e-cigarettes
- NYHA or Killip Class III or IV heart failure at randomization
- Any unstable psychiatric disorder
- Severe renal impairment (creatinine >2 times upper limit or eGFR <15)
- Use of illegal drugs in the past year
- Planned use of smoked cannabis or other 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
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
CONTACT
C
Carole Bohbot
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here