Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04805515

Enrollment

794

Registered

2021-03-18

Start date

2021-02-12

Completion date

2021-05-31

Last updated

2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Cigarettes

Brief summary

Detailed description

This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed for 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use. All participants will be recruited from a US national consumer research panel. Eligible participants will be U.S. adults ages 18+ who are enrolled members of the partnering consumer research panel. The sample will include non-smokers and smokers, oversampling current smokers (defined as smoking 100+ lifetime cigarettes and now smoking all or some days) to ensure the proportion of smokers in the sample reflects the \ 15 % population smoking prevalence among adults. Panel members will be contacted by email with a brief study description and link to an eligibility screener and online informed consent form. Eligible and interested participants will complete the baseline (Wave 1) survey measures of nicotine beliefs and intentions/use of nicotine and tobacco products, after which they will be randomly assigned in equal numbers to the nicotine corrective message (NCM) intervention condition or the delayed message control condition. After completing the baseline survey, participants in the NCM condition will receive their first exposure to the corrective messages. In the Wave 2 survey, all participants will complete measures of nicotine beliefs and intentions/use of nicotine and tobacco products. Participants in the NCM condition will then receive their second exposure to study messages. Only participants in the NCM condition will receive the Wave 3 survey, which involves the third exposure to study messages. The Wave 4 survey will include the fourth exposure to study messages for those in the NCM condition and the final assessment of nicotine beliefs and intentions/use of nicotine and tobacco products for all participants. Upon completion of the final assessment, participants in the control condition will be exposed to the nicotine corrective messages and all participants will be directed to resources on quitting smoking.

Interventions

BEHAVIORALNicotine Corrective Messages

Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

The intervention consists of 8 brief nicotine corrective public education messages delivered online. 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* US resident age 18+ * Member of the partnering consumer research panel conducting the survey * Non-smokers and tobacco cigarette smokers

Exclusion criteria

* Age less than 18 * Not a member of the partnering consumer research panel conducting the study

Design outcomes

Primary

Measure	Time frame	Description
Nicotine Beliefs	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.

Secondary

Measure	Time frame	Description
Intention to Use Nicotine/Tobacco Products	Wave 4 (weeks 11-13)	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.
Tobacco Use	Wave 4 (weeks 11-13)	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).

Other

Measure	Time frame	Description
Attitudes About Nicotine	Wave 4 (weeks 11-13)	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).
Nicotine Related Norms	Wave 4 (weeks 11-13)	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.
Behavioral Control	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).

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
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.	393
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.	401
Total	794

Baseline characteristics

Characteristic	Nicotine Corrective Messages	Delayed Message Control	Total
Age, Customized 18-24	25 Participants	30 Participants	55 Participants
Age, Customized 25-34	78 Participants	84 Participants	162 Participants
Age, Customized 35-44	57 Participants	67 Participants	124 Participants
Age, Customized 45-54	61 Participants	62 Participants	123 Participants
Age, Customized 55-64	74 Participants	71 Participants	145 Participants
Age, Customized 65-74	68 Participants	67 Participants	135 Participants
Age, Customized 75+	30 Participants	20 Participants	50 Participants
Any past 30-day tobacco use	80 Participants	89 Participants	169 Participants
Race/Ethnicity, Customized Asian, non-Hispanic	13 Participants	6 Participants	19 Participants
Race/Ethnicity, Customized Black, non-Hispanic	40 Participants	37 Participants	77 Participants
Race/Ethnicity, Customized Hispanic	73 Participants	79 Participants	152 Participants
Race/Ethnicity, Customized More than 1 race, non-Hispanic	18 Participants	16 Participants	34 Participants
Race/Ethnicity, Customized Other race, non-Hispanic	6 Participants	10 Participants	16 Participants
Race/Ethnicity, Customized White, non-Hispanic	243 Participants	253 Participants	496 Participants
Sex: Female, Male Female	186 Participants	214 Participants	400 Participants
Sex: Female, Male Male	207 Participants	187 Participants	394 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 393	0 / 401
other Total, other adverse events	0 / 393	0 / 401
serious Total, serious adverse events	0 / 393	0 / 401

Outcome results

Primary

Nicotine Beliefs

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.