Impact of Nicotine Messaging on Beliefs and Behavior

NCT ID: NCT05108649

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2024-06-20

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.

Detailed Description

This project will utilize a randomized, factorial design trial to examine the effects of nicotine messaging on nicotine harm beliefs and smoking behavior. After a 7-day period of smoking own preferred brand cigarettes, participants will begin 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. The investigators will aim to recruit and randomize 160 current, daily cigarette smokers (80 male, 80 female) in a 35-day protocol. Participants will be asked to attend 6 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 7, 14, 21, 28 & 35. Sessions will occur every 6-8 days.

Conditions

Smoking Behaviors; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Nicotine Corrective Messaging

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.

Group Type: EXPERIMENTAL

Nicotine Messaging

Intervention Type: 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

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).

Group Type: EXPERIMENTAL

Nicotine Messaging

Intervention Type: 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.

Normal Nicotine Content (NNC) cigarettes

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.

Group Type: EXPERIMENTAL

Cigarette Condition

Intervention Type: 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.

Reduced Nicotine Content (RNC) cigarettes

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.

Group Type: EXPERIMENTAL

Cigarette Condition

Intervention Type: 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.

Interventions

Nicotine Messaging

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.

Intervention Type: OTHER

Cigarette Condition

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Additional, general reasons for exclusion include:

• 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.
• Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn at any point throughout the study.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Rutgers University

OTHER

Sponsor Role: collaborator

Andrew Strasser

OTHER

Sponsor Role: lead

Responsible Party

Andrew Strasser

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrew Strasser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Andrea Villanti, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Center for Interdisciplinary Research for Nicotine Addiction

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA051001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

849654

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 06021

Identifier Type: -

Identifier Source: org_study_id