Aggressive Smoking Cessation Trial (ASAP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Mortimer B. Davis - Jewish General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic symptoms for ≥ 20 min;
Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);
Development of pathological Q waves on the ECG
Ischemic symptoms for ≥ 20 min;
Disqualifiers
Pregnant or lactating females;
Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment [Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.];
Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year;
Previous serious adverse reaction to varenicline and/or e-cigarettes (nicotine or non-nicotine);
Trial design
Design model
Parallel
Treatments tested in this trial
Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)
Combination productVarenicline and nicotine e-cigarettes plus counseling
Varenicline Plus Counseling
Other interventionVarenicline plus counseling
Treatment groups
798 Participants
are divided into 2 treatment groupsGroup A: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)Active comparator 1 intervention
Group B: Varenicline Plus CounselingOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with 7-day point prevalence smoking abstinence
Biochemically-validated 7-day point prevalence smoking abstinence at 24 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm.
Time frame
24 weeksSecondary outcomes
1
Number of participants with continuous smoking abstinence
Biochemically-validated continuous abstinence at 4, 12, and 24 weeks, defined as self-reported abstinence since baseline with exhaled carbon monoxide ≤ 10 ppm at all clinic follow-ups, and self-reported 0 cigarette smoked in the past 7 days at telephone follow-ups (1, 2, 8, and 18 weeks).
Time frame
1, 2, 8, and 18 weeks2
Number of participants with prolonged smoking abstinence
Prolonged abstinence, defined as self-reported abstinence at all clinical and telephone follow-ups after an initial 2-week grace period with exhaled carbon monoxide ≤ 10 ppm at 4, 12, and 24 weeks, and self-reported 0 cigarette smoked in the past 7 days at the 8, and 18 weeks telephone follow-ups.
Time frame
4, 8, 12, 18, and 24 weeks3
Change in daily cigarette consumption
Change in self-reported daily conventional cigarette consumption from baseline compared to 24 weeks.
Time frame
24 weeks4
Number of participants with ≥50% reduction in daily cigarette consumption
Proportion of participants with ≥50% reduction in self-reported daily cigarette consumption from baseline compared to 24-weeks.
Time frame
24 weeksOther outcomes
1
Number of patients with 7-day point prevalence smoking abstinence at 4, 12, and 52 weeks
Biochemically-validated 7-day point prevalence smoking abstinence at 4, 12, and 52 weeks, defined as self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤ 10 ppm.
Time frame
4, 12, and 52 weeks2
Number of patients with continuous abstinence at 4, 12, 24, and 52 weeks
Biochemically-validated continuous abstinence at 4, 12, 24, and 52 weeks, defined as self-reported abstinence since baseline with exhaled carbon monoxide ≤ 10 ppm at all follow-up visits.
Time frame
4, 12, 24, and 52 weeks3
Number of prolonged smoking abstinence at all follow-up visits
Prolonged abstinence, defined as self-reported abstinence at all follow-up visits after an initial 2 weeks grace period with exhaled carbon monoxide ≤ 10 ppm at 4, 12, 24, and 52 weeks.
Time frame
4, 12, 24, and 52 weeks4
Change in daily cigarette consumption at all other weeks
Change in self-reported daily conventional cigarette consumption from baseline at weeks 1, 2, 4, 8, 12, 18, and 52.
Time frame
1, 2, 4, 8, 12, 18, and 52 weeksSponsors and contacts
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Source ClinicalTrials.gov