Trial Outcomes & Findings for Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior (NCT NCT04805515)

NCT ID: NCT04805515

Last Updated: 2022-12-02

Results Overview

3 items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarette false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 794 participants
• Primary outcome timeframe: Wave 4 (weeks 11-13)
• Results posted on: 2022-12-02

Participant Flow

Participants were 794 U.S. English-speaking adults aged 18 and older recruited in spring 2021 from the AmeriSpeak® national consumer market research panel.

Participant milestones

Measure	Nicotine Corrective Messages Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes. Nicotine Corrective Messages: Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes.	Delayed Message Control Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Overall Study STARTED	393	401
Overall Study Wave 2 Survey	313	318
Overall Study COMPLETED	290	319
Overall Study NOT COMPLETED	103	82

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

Baseline characteristics by cohort

Measure	Nicotine Corrective Messages n=393 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=401 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.	Total n=794 Participants Total of all reporting groups
Age, Customized 18-24	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Age, Customized 25-34	78 Participants n=5 Participants	84 Participants n=7 Participants	162 Participants n=5 Participants
Age, Customized 35-44	57 Participants n=5 Participants	67 Participants n=7 Participants	124 Participants n=5 Participants
Age, Customized 45-54	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Age, Customized 55-64	74 Participants n=5 Participants	71 Participants n=7 Participants	145 Participants n=5 Participants
Age, Customized 65-74	68 Participants n=5 Participants	67 Participants n=7 Participants	135 Participants n=5 Participants
Age, Customized 75+	30 Participants n=5 Participants	20 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Female	186 Participants n=5 Participants	214 Participants n=7 Participants	400 Participants n=5 Participants
Sex: Female, Male Male	207 Participants n=5 Participants	187 Participants n=7 Participants	394 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	73 Participants n=5 Participants	79 Participants n=7 Participants	152 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	243 Participants n=5 Participants	253 Participants n=7 Participants	496 Participants n=5 Participants
Race/Ethnicity, Customized Black, non-Hispanic	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Asian, non-Hispanic	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized More than 1 race, non-Hispanic	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Other race, non-Hispanic	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Any past 30-day tobacco use	80 Participants n=5 Participants	89 Participants n=7 Participants	169 Participants n=5 Participants

PRIMARY outcome

Timeframe: Wave 4 (weeks 11-13)

3 items assessing nicotine false beliefs (range 3-11), 6 items assessing nicotine replacement therapy (NRT) false beliefs (range 4-20), 4 items assessing e-cigarette false beliefs (range 2-14), 11 items assessing reduced nicotine content (RNC) cigarette false beliefs (range 14-45), and two items assessing beliefs about additive-free and organic tobacco products. Higher scale scores indicate a higher number of false beliefs.

Outcome measures

Measure	Nicotine Corrective Messages n=290 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=319 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Nicotine Beliefs Nicotine false beliefs (range 3-11)	7.5 score on a scale Standard Deviation 2.3	7.8 score on a scale Standard Deviation 2.1
Nicotine Beliefs NRT false beliefs (range 4-20)	10.9 score on a scale Standard Deviation 2.8	11.3 score on a scale Standard Deviation 2.8
Nicotine Beliefs E-cigarette false beliefs (range 2-14)	8.9 score on a scale Standard Deviation 2.2	9.2 score on a scale Standard Deviation 2.1
Nicotine Beliefs Reduced nicotine content cigarette false beliefs (range 14-45)	29.8 score on a scale Standard Deviation 4.7	30.3 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: Wave 4 (weeks 11-13)

Population: The number of participants analyzed differs from the overall number due to item non-response.

Four items assessing intention to use tobacco cigarettes, e-cigarettes, NRT, and RNC cigarettes during the next 12 months. Adapted from PhenX Toolkit- Susceptibility to Tobacco Products, response options Definitely Yes; Probably Yes; Probably Not; Definitely Not. Outcomes reported for participants reporting Definitely Yes or Probably Yes to each item.

Outcome measures

Measure	Nicotine Corrective Messages n=290 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=319 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Intention to Use Nicotine/Tobacco Products Cigarette	56 Participants	50 Participants
Intention to Use Nicotine/Tobacco Products E-cigarette/vape	20 Participants	27 Participants
Intention to Use Nicotine/Tobacco Products Nicotine replacement product	20 Participants	23 Participants
Intention to Use Nicotine/Tobacco Products Low nicotine cigarette	28 Participants	15 Participants

SECONDARY outcome

Timeframe: Wave 4 (weeks 11-13)

Population: Analyses restricted to participants who reported any past 30-day tobacco use at baseline.

Number of days used tobacco in the past 30 days. Days used summed across eight different nicotine/tobacco products (e.g., tobacco cigarettes, e-cigarettes, cigars, NRT, RNC cigarettes).

Outcome measures

Measure	Nicotine Corrective Messages n=80 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=89 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Tobacco Use	18.6 Days Standard Deviation 16.5	18.4 Days Standard Deviation 18.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Wave 4 (weeks 11-13)

Population: The analytic sample differs from the overall sample due to item non-response.

Three items on nicotine-related attitudes using semantic differentials across five-point Likert scales. 'Using Nicotine is:' Safe (1) - Dangerous (5); Positive (1) - Negative (5); Good (1) - Bad (5).

Outcome measures

Measure	Nicotine Corrective Messages n=290 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=319 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Attitudes About Nicotine Safe to Dangerous	4.4 score on a scale Standard Deviation 0.9	4.5 score on a scale Standard Deviation 0.8
Attitudes About Nicotine Positive to Negative	4.6 score on a scale Standard Deviation 0.7	4.5 score on a scale Standard Deviation 0.8
Attitudes About Nicotine Good to Bad	4.6 score on a scale Standard Deviation 0.8	4.6 score on a scale Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Wave 4 (weeks 11-13)

Population: The analytic sample differs from the overall sample due to item non-response.

Two items: "How would you describe most people's opinion of using nicotine?" and "Thinking about the people who are important to you, how would you describe their opinion on using nicotine?" with five-point Likert scale responses ranging from "very negative" (1) to "very positive" (5). Higher scores indicate positive norms of using nicotine.

Outcome measures

Measure	Nicotine Corrective Messages n=290 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=319 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Nicotine Related Norms People who are important to you	1.9 score on a Likert scale Standard Deviation 0.9	2.1 score on a Likert scale Standard Deviation 1.0
Nicotine Related Norms Most people	2.1 score on a Likert scale Standard Deviation 0.7	2.2 score on a Likert scale Standard Deviation 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Wave 4 (weeks 11-13)

One item assessing confidence to resist smoking cigarettes when others are smoking (1=not at all confident to 4=very confident).

Outcome measures

Measure	Nicotine Corrective Messages n=290 Participants Participants in the nicotine corrective messages condition will receive 8 brief nicotine corrective public education messages delivered online during 4 waves of the 12 week study. The messages will communicate misperceptions about nicotine's role in health harms as well as misperceptions that reduced nicotine content cigarettes are less harmful than tobacco cigarettes and that e-cigarettes contain less nicotine than tobacco cigarettes.	Delayed Message Control n=318 Participants Participants in the control condition will be exposed to the nicotine corrective messages after the completion of the final assessment at the end of the 12 week study.
Behavioral Control	3.6 score on a scale Standard Deviation 0.8	3.6 score on a scale Standard Deviation 0.9

Adverse Events

Nicotine Corrective Messages

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Message Control

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

Andrea Villanti

Rutgers Center for Tobacco Studies

Phone: 732 235 9585

Email: andrea.villanti@rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place