Clinical trial NCT05108649: Impact of Nicotine Messaging on Beliefs and Behavior
Official title: Study 2: Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Behaviors
Cigarette Smoking
Keywords: Smoking Behavior
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
name: National Institute on Drug Abuse (NIDA)
name: Rutgers University
First posted: 2021-11-05
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in nicotine beliefs
timeFrame: Day 0 through 35
measure: Manipulation Check (changes over time)
timeFrame: Day 0 through 35
Secondary outcomes:
measure: Daily Cigarette Consumption
timeFrame: Day 0 through Day 35
measure: Puff Duration
timeFrame: Day 0, 7, 14, 21, 28 and 35
measure: Carbon Monoxide (CO)
timeFrame: Days 0, 7, 14, 21, 28 and 35
measure: Total Nicotine Equivalents
timeFrame: Days 7 and 35
measure: Total NNAL
timeFrame: Days 7 and 35
measure: Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)
timeFrame: Days 0, 7, 14, 21, 28 and 35
measure: Intention to use Tobacco/ Nicotine
timeFrame: Days 0, 14 and 35
measure: Nicotine/Tobacco Use and Behavior
timeFrame: Days 0, 14 and 35
measure: Attitudes about Nicotine
timeFrame: Days 0, 14 and 35
measure: Nicotine Related Norms
timeFrame: Days 0, 14 and 35
measure: Behavioral Control
timeFrame: Days 0, 14 and 35
measure: Cigarette Risk Beliefs
timeFrame: Days 0, 7, 21, and 35
measure: Cigarette Craving (Questionnaire on Smoking Urges [QSU])
timeFrame: Days 0, 7, 14, 21, 28 and 35
measure: Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])
timeFrame: Days 0, 7, 14, 21, 28 and 35
measure: Additional Topographic/Puffing Behaviors
timeFrame: Days 0, 7, 14, 21, 28 and 35
measure: Stages of Change
timeFrame: Day 0 and 35
measure: Policy Support
timeFrame: Day 0 and 35
measure: Perceived Message Effectiveness
timeFrame: Day 35
measure: Message Credibility
timeFrame: Day 35
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research for Nicotine Addiction
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Strasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Andrea Villanti, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: