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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-14

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults

NCT02937051

Tobacco Products

COMPLETED NA

Impact of Cigar Flavor in Dual Users

NCT04487470

Tobacco Use Disorder

COMPLETED NA

Attitudes and Smoking Perceptions in the Real Environment

NCT06617520

Tobacco Use

COMPLETED NA

Attitudes and Perceptions Attitudes and Smoking Perceptions in the Real Environment -II

NCT06668350

Cigarillo Flavor

RECRUITING NA

Addictive Potential of LCCs in Dual Users

NCT03496077

Tobacco Use Disorder Dual Tobacco Use Tobacco Dependence +4 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Cigar Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flavor

Either a sweet-flavored or a non-flavored cigarillo

Group Type OTHER

Flavor

Intervention Type OTHER

Sweet flavored vs. non-flavored cigarillos.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flavor

Sweet flavored vs. non-flavored cigarillos.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes