Trial Outcomes & Findings for Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers (NCT NCT00843622)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

250 participants

Primary outcome timeframe

Week 6-28

Results posted on

2014-06-17

Participant Flow

Participants recruited from database of clinical trial volunteers, and media ads

Participants were checked for eligibility prior to group assignment

Participant milestones

Participant milestones
Measure	Active Snus Tobacco-based, smokefree product	Placebo Snus Non-tobacco, non-nicotine placebo product
Overall Study STARTED	125	125
Overall Study COMPLETED	82	70
Overall Study NOT COMPLETED	43	55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Snus n=125 Participants Tobacco-based, smokefree product	Placebo Snus n=125 Participants Non-tobacco, non-nicotine placebo product	Total n=250 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=5 Participants	125 Participants n=7 Participants	250 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	71 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	54 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment United States	125 participants n=5 Participants	125 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6-28

Outcome measures

Outcome measures
Measure	Active Snus n=125 Participants Tobacco-based, smokefree product	Placebo Snus n=125 Participants Non-tobacco, non-nicotine placebo product
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm	5 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, week 6, 10, 16 and 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 16 and 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 6, 16, and 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6, 16, 28 weeks

7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6-16 weeks

Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits

Outcome measures

Outcome data not reported

Adverse Events

Active Snus

Serious events: 2 serious events

Other events: 53 other events

Deaths: 0 deaths

Placebo Snus

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Snus n=125 participants at risk Tobacco-based, smokefree product	Placebo Snus n=125 participants at risk Non-tobacco, non-nicotine placebo product
Reproductive system and breast disorders Vaginal bleeding	1.6% 2/125 • Number of events 2 • 6 months	0.00% 0/125 • 6 months
Nervous system disorders Severe visual disturbance	0.00% 0/125 • 6 months	0.80% 1/125 • Number of events 1 • 6 months
Musculoskeletal and connective tissue disorders severe multiple fractures in right ankle due to car accident	0.00% 0/125 • 6 months	0.80% 1/125 • Number of events 1 • 6 months

Other adverse events

Other adverse events
Measure	Active Snus n=125 participants at risk Tobacco-based, smokefree product	Placebo Snus n=125 participants at risk Non-tobacco, non-nicotine placebo product
Gastrointestinal disorders Gingival pain, nausea, dyspepsia etc	42.4% 53/125 • Number of events 53 • 6 months	29.6% 37/125 • Number of events 37 • 6 months

Additional Information

Dr Karl Fagerström

Fagerström Consulting AB

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place