Impact of Nicotine Messaging on Beliefs and Behavior

NCT05108649 | Completed Results

• 3 other identifiers: UPCC 06021R01DA051001849654
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of nicotine messaging and nicotine content of study cigarettes on nicotine beliefs and subsequent use of tobacco and nicotine products.

Conditions

Smoking Behaviors; Cigarette Smoking

Keywords

Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• Nicotine Beliefs

  Nicotine belief measures will be assessed by participant self-report and comprised of four broad constructs (nicotine beliefs, NRT beliefs, e-cigarette beliefs, and RNC cigarette beliefs). Nicotine beliefs relate specifically to its addictive nature, nicotine as a cause of cancer, and the role of nicotine in the health harms and cancer caused by smoking. The product-specific constructs (i.e., NRT, e-cigarette, RNC cigarette) include items related to the addictiveness of the product and the perceived health risks of the product compared to regular cigarettes. Three 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) cigarettes 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.

  Day 35

Secondary Outcomes (6)

• Daily Cigarette Consumption

  Day 35

• Puff Duration

  Day 35

• Carbon Monoxide (CO)

  Day 35

• Number of Participants With Intention to Use Tobacco/Nicotine Products

  Day 35

• Tobacco Use

  Day 35

Other Outcomes (3)

• Behavioral Control

  Day 35

• Nicotine Related Norms

  Day 35

• Attitudes About Nicotine

  Day 35

Study Arms (4)

Nicotine Corrective Messaging

EXPERIMENTAL

After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session.

Other: Nicotine Messaging

Delayed Control Messaging

EXPERIMENTAL

After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will not view nicotine messaging until the final study session (Delayed Control Messaging).

Other: Nicotine Messaging

Normal Nicotine Content (NNC) cigarettes

EXPERIMENTAL

After completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive normal nicotine content cigarettes.

Other: Cigarette Condition

Reduced Nicotine Content (RNC) cigarettes

EXPERIMENTAL

After completing a 7-day baseline period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content cigarettes.

Other: Cigarette Condition

Interventions

Cigarette Condition OTHER

After completing a 7-day period of smoking own brand cigarettes, participants will be randomized to a 28-day experimental period and will receive reduced nicotine content (RNC) cigarettes or normal nicotine content (NNC) cigarettes.

Normal Nicotine Content (NNC) cigarettes; Reduced Nicotine Content (RNC) cigarettes

Nicotine Messaging OTHER

After completing a 7-day baseline period, participants will be randomized to a 28-day experimental period and will view nicotine corrective messaging at each in-person session or delayed control messaging at the final study session.

Delayed Control Messaging; Nicotine Corrective Messaging

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months.
• Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (\~6 weeks).
• Plan to live in the area for the duration of the study.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
• Able to communicate fluently in English (i.e., speaking, writing, and reading).

You may not qualify if:

• Smoke menthol cigarettes greater than 20% of the time.
• Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.)
• Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
• Attempt to quit smoking over the duration of the study period.
• Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0).
• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
• Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
• Color blindness.
• Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
• Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
• Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
• Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal Investigator and/or Study Physician.
• Any circumstance, medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.

Sponsors & Collaborators

• Food and Drug Administration (FDA): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Andrew Strasser: lead
• Rutgers University: collaborator

Study Sites (1)

Center for Interdisciplinary Research for Nicotine Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Results Point of Contact

• Title: Valentina Goren, MRA Project Manager
• Organization: University of Pennsylvania

vsoup@pennmedicine.upenn.edu

215-746-3602

Study Officials

• Andrew Strasser, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Andrea Villanti, Ph.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unblinded to the nicotine content of their cigarette, either normal nicotine content (NNC) cigarettes or reduced nicotine content (RNC) cigarettes. However, participants will not be aware of the messaging condition assignment, either Nicotine Corrective Messaging (NCM) or the Delayed Control Messaging.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: This project will recruit current, daily, non-menthol cigarette smokers to a 35-day, randomized, factorial design protocol. After a 7-day period of smoking own preferred brand cigarettes, participants will be randomized to a 28-day experimental period and will be randomized to one of four conditions: 1) Nicotine Corrective Messaging (NCM) + Reduced nicotine content (RNC) cigarettes, 2) NCM + normal nicotine content (NNC) cigarettes, 3) Delayed Control Messaging + RNC cigarettes, or 4) Delayed Control Messaging + NNC cigarettes.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 5, 2021
• Study Start: March 2, 2022
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-11

Locations

US (1)