Trial Outcomes & Findings for Acceptability of Less Harmful Alternatives to Cigarettes (NCT NCT00957424)

NCT ID: NCT00957424

Last Updated: 2017-02-07

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

Baseline

Results posted on

2017-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Noncombusted Nicotine Product With Informational Intervention Single-armed study
Overall Study STARTED	67
Overall Study Follow-up #1	59
Overall Study Follow-up #2	50
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Noncombusted Nicotine Product With Informational Intervention Single-armed study
Overall Study Lost to Follow-up	19
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Acceptability of Less Harmful Alternatives to Cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=67 Participants Single-armed study
Age, Continuous	46.7 years STANDARD_DEVIATION 9.59 • n=99 Participants
Gender Female	35 Participants n=99 Participants
Gender Male	32 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	19 Participants n=99 Participants
Race (NIH/OMB) White	42 Participants n=99 Participants
Race (NIH/OMB) More than one race	5 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	67 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Overall n=67 Participants Single-armed study
Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)	7 participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Overall n=67 Participants Single-armed study
Number of Participants Willing to Try HRPs	60 participants

PRIMARY outcome

Timeframe: One week

Outcome measures

Outcome measures
Measure	Overall n=67 Participants Single-armed study
Number of Participants That Completed 1-week Trial	50 participants

PRIMARY outcome

Timeframe: 1 week follow up

Population: Those who completed one-week multiple product sampling

Outcome measures

Outcome measures
Measure	Overall n=50 Participants Single-armed study
Number of Participants Willing to Continue With Preferred HRP	49 participants

Adverse Events

Overall

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard O'Connor

Roswell Park Cancer Institute

Phone: 716-845-4517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place