The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults

NCT05092919 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 843944
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

This within-subjects study aims to evaluate the subjective rewarding value, the relative reinforcing value, and the absolute reinforcing value of sweet flavored cigarillos across three separate laboratory visits among 86 young adults (ages 18-24 years old) who have previously smoked \> 10 or more cigarillos in their lifetime.

Conditions

Tobacco Use; Cigar Smoking

Outcome Measures

Primary Outcomes (3)

• Subjective Rewarding Value of Cigarillo Flavoring

  Subjective rewarding value of cigarillo flavoring will be measured with the Cigarette Evaluation Scale (CES) adapted for cigarillo use. The CES is an 11 item Likert-format (1=not at all to 7=extremely) self-report instrument with established validity and reliability (α \> .80). The investigators will focus on the sum of the two-item satisfaction subscale ("Was it satisfying?" and "Did it taste good?") to calculate the subjective rewarding value. The minimum possible score is 2 and the maximum is 14. Higher scores denote greater subjective rewarding value. Primary Outcome measured at visit 1.

  Laboratory visit 1 (Day 1, 1.5 hours)

• Relative Reinforcing Value of Cigarillo Flavoring

  Relative reinforcing value of cigarillo flavoring will be measured with a validated choice paradigm, evaluating the preference for sweet flavored (the cigarillo with the highest rewarding value measured in visit 1) relative to non-flavored cigarillos. The reinforcement schedule in the non-flavored cigarillo remained constant at a fixed ratio FR-25, while the reinforcement schedule for the sweet-flavored cigarillo increased with a progressive ratio schedule of PR-25x over 10 trials. RRVF will be defined by the breakpoint (highest trial completed across 10 trials to earn puffs for sweet flavored versus non-flavored cigarillos). Higher breakpoints indicate a greater relative reinforcing value. Primary Outcome measured at visit 2.

  Laboratory visit 2 (Day 2, 2 hours)

• Absolute Reinforcing Value of Cigarillo Flavoring

  Absolute reinforcing value of cigarillo flavoring is operationalized as the number of sweet flavored versus non-flavored cigarillo puffs consumed during the ad libitum smoking session. A research assistant will videotape, monitor, and count the number of cigarillo puffs taken during the 90-minute period. The primary comparison is the amount of consumption (puffs) of the sweet flavored (determined at visit 1) versus non-flavored cigarillo. A greater number of puffs indicates a higher absolute reinforcing value. Primary Outcome measured at visit 3.

  Laboratory visit 3 (Day 3, 2.5 hours)

Study Arms (1)

Flavor

OTHER

Either a sweet-flavored or a non-flavored cigarillo

Other: Flavor

Interventions

Flavor OTHER

Sweet flavored vs. non-flavored cigarillos.

Flavor

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to communicate fluently in English (i.e. speaking, writing, and reading).
• Male and female young adults who are between 18 and 24 years of age who have used \> 10 cigarillos in their lifetime.
• Not currently undergoing smoking cessation treatment or planning to quit smoking cigarettes within the next 30 days.
• Plan to live in the area for the duration of the study.
• Willing to use study-provided cigarillos during three laboratory visits.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.

You may not qualify if:

• Smoking Behavior
• Use of less than 10 cigarillos in lifetime
• Current enrollment or plans to enroll in a tobacco cessation program over the duration of the study.
• Current use of nicotine replacement therapy or other smoking cessation medication.
• Alcohol and Drug
• History of substance abuse (other than nicotine dependence) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Breath alcohol reading (BrAC) greater than .000 at Laboratory Visit 1.
• Use of e-cigarettes on \>5 days in the past 30 days.
• Medical
• 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.
• Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
• Psychiatric
• Lifetime history of schizophrenia or psychosis
• Lifetime history of a suicide attempt.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Audrain-McGovern J, Manikandan D, Koita F, Klapec O, Pickworth WB, Stone MD. Effect of sweet flavouring on the rewarding and reinforcing value of cigarillo use among young adults. Tob Control. 2025 May 15;34(3):294-301. doi: 10.1136/tc-2023-058307.

  PMID: 38050181 DERIVED

MeSH Terms

Conditions

Tobacco Use; Cigar Smoking

Interventions

Flavoring Agents

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Smoking

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry
• Organization: Perelman School of Medicine, University of Pennsylvania

audrain@pennmedicine.upenn.edu

(215) 746-7145

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 26, 2021
• Study Start: September 14, 2021
• Primary Completion: February 28, 2023
• Study Completion: May 31, 2023
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)