Clinical trial NCT05092919: The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
Official title: The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tobacco Use
Cigar Smoking
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Smoking Behavior

1. Use of less than 10 cigarillos in lifetime
2. Current enrollment or plans to enroll in a tobacco cessation program over the duration of the study.
3. Current use of nicotine replacement therapy or other smoking cessation medication.

Alcohol and Drug

1. 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.
2. Current alcohol consumption that exceeds 25 standard drinks/week.
3. Breath alcohol reading (BrAC) greater than .000 at Laboratory Visit 1.
4. Use of e-cigarettes on \>5 days in the past 30 days.

Medical

1. 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.
2. 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

1. Lifetime history of schizophrenia or psychosis
2. Lifetime history of a suicide attempt.
3. Current use of medications used to treat mood, such as depression or anxiety.

   1. Individuals will be excluded if they take psychotropic medications that may impact laboratory assessments of nicotine/flavoring reward and reinforcement.
   2. Participants with a history of depression or anxiety will not be excluded- however, participants who are currently taking any medications used to treat these will be ineligible to participate.
   3. Participants who are not currently taking these medications but are receiving treatment such as therapy or counseling will be eligible to participate.
4. Current or recent use of anti-psychotic medications.

General Exclusion

1. 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.
2. Any 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. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
3. Significant non-compliance with protocol and/or study design as determined by the Principal Investigator. Subjects may be deemed ineligible at any point throughout the study.

Primary outcomes:
measure: Subjective Rewarding Value of Cigarillo Flavoring
timeFrame: Laboratory visit 1 (Day 1, 1.5 hours)
measure: Relative Reinforcing Value of Cigarillo Flavoring
timeFrame: Laboratory visit 2 (Day 2, 2 hours)
measure: Absolute Reinforcing Value of Cigarillo Flavoring
timeFrame: Laboratory visit 3 (Day 3, 2.5 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: