Trial Outcomes & Findings for Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco (NCT NCT03860077)

Results Overview

Average number of cigarettes (study and non-study) smoked in the past week prior to the final session.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

57 participants

Primary outcome timeframe

Week 4

Results posted on

2023-12-19

Participant Flow

Participants were consented at Screening/Baseline 1 (N=57). Those who remained eligible and interested were randomized at Baseline 2 (N=49). Participant flow was documented for randomized participants.

Participant milestones

Participant milestones
Measure	Normal Nicotine Content Cigarettes Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette
Overall Study STARTED	25	24
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Nicotine Reduction on Adolescent Cigarette Use, Alternative Tobacco Use, and Harm From Tobacco

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Nicotine Content Cigarettes n=25 Participants Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes n=24 Participants Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette	Total n=49 Participants Total of all reporting groups
Age, Continuous	18.72 years STANDARD_DEVIATION 0.73 • n=5 Participants	19.08 years STANDARD_DEVIATION 0.88 • n=7 Participants	18.90 years STANDARD_DEVIATION 0.82 • n=5 Participants
Sex/Gender, Customized Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex/Gender, Customized Female	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Sex/Gender, Customized Transgender, genderqueer, or other identity not listed	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Cigarettes per day	6.3 Cigarettes smoked per day STANDARD_DEVIATION 4.4 • n=5 Participants	7.6 Cigarettes smoked per day STANDARD_DEVIATION 7.4 • n=7 Participants	6.9 Cigarettes smoked per day STANDARD_DEVIATION 6.0 • n=5 Participants
Carbon Monoxide	10.4 parts per million STANDARD_DEVIATION 9.6 • n=5 Participants	11.5 parts per million STANDARD_DEVIATION 11.7 • n=7 Participants	11.02 parts per million STANDARD_DEVIATION 10.6 • n=5 Participants
Baseline Number of Other Tobacco Use Days in Past 30	4.32 Days in past 30 days STANDARD_DEVIATION 5.70 • n=5 Participants	5.7 Days in past 30 days STANDARD_DEVIATION 3.5 • n=7 Participants	5.0 Days in past 30 days STANDARD_DEVIATION 3.61 • n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Participants who completed week 4

Average number of cigarettes (study and non-study) smoked in the past week prior to the final session.

Outcome measures

Outcome measures
Measure	Normal Nicotine Content Cigarettes n=21 Participants Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes n=17 Participants Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette
Average Cigarettes Smoked Per Day	4.3 average cigarettes per day Standard Deviation 2.6	8.0 average cigarettes per day Standard Deviation 10.33

PRIMARY outcome

Timeframe: Week 4

Population: Those who completed Week 4 are included in the outcome means.

Average number of days of combustible and noncombustible use. This measure is a sum of the days of combustible use (out of 7 days) and noncombustible use (out of 7 days) recorded in the week prior to week 4, averaged over 14 days. As this measure is a sum of the two variables, its possible range is 0-14.

Outcome measures

Outcome measures
Measure	Normal Nicotine Content Cigarettes n=21 Participants Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes n=17 Participants Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette
Average Number of Days of Combustible and Noncombustible Use	4.80 days Standard Deviation 3.12	5.17 days Standard Deviation 3.87

SECONDARY outcome

Timeframe: Week 4

Population: Those who completed week 4.

Number of days of noncombustible tobacco product use in the past 7 days prior to week 4

Outcome measures

Outcome measures
Measure	Normal Nicotine Content Cigarettes n=21 Participants Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes n=17 Participants Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette
Amount of Noncombustible Alternative Product Use	4.76 average days Standard Deviation 3.11	4.29 average days Standard Deviation 3.4

SECONDARY outcome

Timeframe: Week 4

Average number of study cigarettes smoked per day across 7 days prior to week 4

Outcome measures

Outcome measures
Measure	Normal Nicotine Content Cigarettes n=21 Participants Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes n=17 Participants Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette
Average Study Cigarettes Per Day	3.32 average cigarettes per day Standard Deviation 2.86	4.98 average cigarettes per day Standard Deviation 5.92

SECONDARY outcome

Timeframe: Week 4

Population: All participants who provided urine data at Week 4, and for whom there were analyzable levels of TNEs.

Total Nicotine Equivalents (TNEs)

Outcome measures

Outcome measures
Measure	Normal Nicotine Content Cigarettes n=19 Participants Normal Nicotine Content Cigarettes:15.8 mg/g nicotine per cigarette	Very Low Nicotine Content Cigarettes n=15 Participants Very Low Nicotine Content Cigarettes: 0.4 mg/g nicotine per cigarette
Toxicant Exposure	3875.395 ng/ml Standard Deviation 4700.761	6284.507 ng/ml Standard Deviation 6641.2956

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Respiratory Health Symptoms; an 8-item questionnaire measuring frequency of experience respiratory symptoms; scores can range from 8 to 40 and greater scores indicate greater frequency.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 4

Perceived risk for developing diseases associated with use study cigarettes and usual brand cigarettes; Scores range from 1 (much less risk) to 5 (much greater risk) for each disease

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Modified Fagerstrom Tolerance Questionnaire (mFTQ) score; Scale 2-8, higher scores indicate greater nicotine dependence

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Questionnaire on Smoking Urges (QSU) post- smoking in the laboratory, a 10 item scale that is comprised of 2 factors; Factor 1 included items 1, 3, 6, 7, and 10 Factor 2 included items 2, 4, 5, 8, and 9 The score for each factor is calculated by summing the item scores; the total score is calculated by summing all 10 items. A single-item craving question (ranging from 1-10, not all to greatly) from daily random and post-event Ecological Momentary Assessments.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Minnesota Nicotine Withdrawal Scale 7-item version; greater score indicates greater withdrawal

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Cigarette Evaluation Scale post-smoking in the laboratory; 5 subscales are derived from this scale: Psychological Reward, Smoking Satisfaction, Enjoyment of Respiratory Sensations, Craving Reduction; Aversion. Event level on satisfaction derived from post-use responses on daily Ecological Momentary Assessments.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Cigarette Purchase Task; Five indices of demand for cigarettes are derived from this measure (Intensity, Omax, Breakpoint, Pmax, Alpha)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline-Week 4

Purchasing of cigarettes and other tobacco products across changing prices in Experimental Tobacco Marketplace task

Outcome measures

Outcome data not reported

Adverse Events

Very Low Nicotine Content Cigarettes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Nicotine Content Cigarettes

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

Dr. Rachel Cassidy

Brown University

Phone: 4018636621

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place