Trial Outcomes & Findings for Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers (NCT NCT00711100)

Results Overview

Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

2 weeks

Results posted on

2019-11-18

Participant Flow

Subjects were recruited 10/2008 through 8/2009 through local advertisements in Minnesota and Oregon.

Sampling Phase preceded the 2 week Abstinence Phase. Sampling phase involved sampling each study product for a 1/2 day; subjects then chose the product that they would like to use for a two week cigarette abstinence period

Participant milestones

Participant milestones
Measure	Oral Tobacco Products Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
Overall Study STARTED	104
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Tobacco Products Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
Overall Study Lack of Efficacy	5
Overall Study Withdrawal by Subject	8

Baseline Characteristics

Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Tobacco Products n=104 Participants Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
Age, Continuous	40.1 years STANDARD_DEVIATION 13.2 • n=93 Participants
Sex: Female, Male Female	40 Participants n=93 Participants
Sex: Female, Male Male	64 Participants n=93 Participants
Region of Enrollment United States	104 participants n=93 Participants
Age, Categorical <=18 years	2 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).

Outcome measures

Outcome measures
Measure	Camel Snus n=98 Participants Number of participants who sampled Camel Snus	Marlboro Snus n=98 Participants Number of participants who sampled Marlboro Snus	Stonewall n=98 Participants Number of participants who sampled Stonewall	Ariva n=98 Participants Number of participants who sampled Ariva	General Snus n=98 Participants Number of partiicipants who sampled General Snus
Product Preference	27 participants	23 participants	24 participants	24 participants	0 participants

PRIMARY outcome

Timeframe: Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)

Population: At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase. Abstinence from cigarettes was determined during the 2 week study product phase (e.g., Abstinence Phase) and 1 week after this phase.

Abstinence from cigarettes during Abstinence Phase.