Cigarillo Flavors for Tobacco Use

(ASPIRE Trial)

Overseen By Michael Smith, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Nicotine replacement therapy

Disqualifiers: Pregnancy, Heart disease, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will measure appeal and reinforcement for different flavored little cigars/cigarillos (LCCs) in young adults in the laboratory and at-home, via ecological momentary assessment (daily smart-phone surveys)

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use nicotine replacement therapy (NRT).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use nicotine replacement therapy (NRT) during the study.

What data supports the idea that Cigarillo Flavors for Tobacco Use is an effective treatment?

The available research does not provide any data supporting the effectiveness of Cigarillo Flavors for Tobacco Use as a treatment. The studies mentioned focus on different drugs and conditions, primarily related to Parkinson's disease and other dopamine-related treatments, but do not address Cigarillo Flavors for Tobacco Use. ^{1 2 3 4 5}

What safety data exists for cigarillo flavors in tobacco use?

Existing safety data indicates that flavored cigarillos and little cigars pose health risks similar to cigarettes, exposing users to toxicants like nicotine and carbon monoxide. Studies show variability in toxicant levels based on flavor and brand, with some flavors causing higher oxidative stress. Cigarillo smoke contains more toxicants than cigarette smoke, and regulation of flavoring chemicals is recommended to prevent adverse health effects. ^{6 7 8 9 10}

Is smoking flavored cigarillos safe for humans?

Flavored cigarillos expose users to harmful substances similar to cigarettes, including nicotine and other toxic chemicals. They can cause oxidative stress and cellular damage, with some flavors being more toxic than others, but generally not more harmful than cigarettes. Regulation of these products is suggested due to their potential health risks. ^{6 7 8 9 10}

Is the treatment in the trial 'Cigarillo Flavors for Tobacco Use' a promising treatment?

The provided research articles do not contain any information about the trial 'Cigarillo Flavors for Tobacco Use' or its treatment, so we cannot determine if it is promising based on this data. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for young adults who currently smoke little cigars or cigarillos. Participants must be willing to try different flavors of these products and complete daily surveys on their smartphones both in a lab setting and at home.

Inclusion Criteria

Smoke little cigars/cigarillos (LCCs) 'some days' or 'everyday'

Ability to read English at an 8th grade level or higher

No immediate plans to quit using tobacco

Exclusion Criteria

Pregnant, planning to become pregnant, or currently breastfeeding

Inability to abstain from nicotine/tobacco products for at least 12 hours prior to each of two study sessions

Report using the study cigarillo brand as their preferred brand (as this will likely unduly influence their perceptions)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants measure appeal to smoking their usual brand cigarillo in their home environment for 7 days and then once in the laboratory after >12-hour abstinence

1 week

1 visit (in-person)

Experimental Conditions

Participants undergo 3 experimental conditions, each lasting 7 days, where they smoke different flavored cigarillos at home and once in the laboratory

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for subjective response to smoking and number of cigarillos smoked

3 weeks

Treatment Details

Interventions

• Cigarillo flavor type

Trial Overview The study is examining how appealing and reinforcing various flavored little cigars/cigarillos are to young adult smokers. It involves laboratory assessments as well as real-world monitoring through daily smartphone surveys.

Participant Groups

Group I: Tobacco flavor cigarillo Experimental Treatment 1 Intervention

A participant will use a tobacco flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory

Group II: Concept flavor cigarillo Experimental Treatment 1 Intervention

A participant will use a concept flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory

Group III: Characterizing flavor Experimental Treatment 1 Intervention

A participant will use a characterizing flavored cigarillo at home for 7-days, as they wish, and then smoke it once in the laboratory

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Presbyterian Health Foundation

Collaborator

Trials

2

Recruited

80+

Findings from Research

In a 6-month double-blind trial involving 20 patients with Parkinson's disease, both pergolide mesylate and placebo showed significant improvements in symptoms, with the pergolide group improving by 30% and the placebo group by 23%.

Although there was no significant difference between the pergolide and placebo groups, suggesting that the benefits of pergolide may have been influenced by external factors, the study still indicates that pergolide has a definite antiparkinsonian effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind trial of pergolide for Parkinson's disease. Diamond, SG., Markham, CH., Treciokas, LJ.[2019]

Dopamine receptor agonists, including both ergolinic and non-ergolinic types, are effective for treating symptoms of Parkinson's disease and can help reduce motor complications related to levodopa, but they do not demonstrate a disease-modifying effect.

While these medications can improve symptoms, they also carry risks of adverse reactions such as nausea, hallucinations, and impulse-control disorders, which were identified during both pre-marketing trials and post-marketing surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dopamine receptor agonists for the treatment of early or advanced Parkinson's disease. Perez-Lloret, S., Rascol, O.[2021]

In an open trial involving 23 patients with idiopathic Parkinson's disease who had previously experienced loss of efficacy or side effects from other treatments, pergolide mesylate showed improvement in parkinsonian symptoms that lasted for 6 months.

All patients experiencing the on-off phenomenon, a common issue in Parkinson's treatment, reported relief from their symptoms while on pergolide, and no significant side effects were observed, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pergolide mesylate and idiopathic Parkinson disease. Tanner, CM., Goetz, CG., Glantz, RH., et al.[2019]

Aripiprazole demonstrated unique clinical responses in three cases, including an adverse reaction of problem gambling behavior, highlighting the need for careful monitoring of side effects.

In one case, aripiprazole enhanced the antipsychotic response in a patient with delusional disorder and reversed weight gain associated with olanzapine, suggesting its potential benefits in managing side effects of other antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary: Aripiprazole: The Second Wave of the Second-generation Antipsychotics. Kahn, DA.[2021]

In a study of 73 prolactinoma patients treated with cabergoline (CAB) for an average of 64 months, only 17% showed abnormal diffusion capacity for carbon monoxide (DLCO), suggesting minimal pulmonary side effects.

The findings indicate that CAB is generally safe regarding lung function, as no direct correlation was found between the cumulative dose of CAB and the abnormal DLCO results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pulmonary side effects in prolactinoma patients treated with cabergoline. Soyluk, O., Bingol, Z., Ciftci, S., et al.[2023]

Over half of U.S. adults perceive flavors in flavored little cigars, cigarillos, and filtered cigars (LCCs) as risky, but a significant portion (over one-third) are unsure about the risks, indicating a gap in public knowledge.

Younger adults and LCC users are more likely to view these flavors as less risky, and those who perceive them as 'not at all risky' are about twice as likely to have used flavored LCCs, suggesting that risk perception is closely linked to actual use of these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavors and Risk: Perceptions of Flavors in Little Cigars and Cigarillos Among U.S. Adults, 2015. Nyman, AL., Sterling, KL., Majeed, BA., et al.[2023]

Cigarillo smoking, specifically with Black & Mild, significantly increases plasma nicotine levels and heart rate, indicating that it delivers active doses of nicotine similar to cigarettes, which may contribute to nicotine dependence.

Despite the nicotine delivery, smoking cigarillos does not reliably alleviate withdrawal symptoms from nicotine or tobacco, and the exposure to carbon monoxide poses additional health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of cigarillo smoking. Blank, MD., Nasim, A., Hart, A., et al.[2022]

Flavored little cigars and cigarillos exhibit significant variability in their physicochemical properties and oxidative stress potential, with many showing a higher capacity to generate reactive oxygen species compared to research-grade cigarettes.

Certain flavors, particularly 'fruits/candy' and 'drinks', were found to be highly toxic to bronchial epithelial cells, highlighting the need for better regulation and characterization of flavoring chemicals in these tobacco products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classification of flavors in cigarillos and little cigars and their variable cellular and acellular oxidative and cytotoxic responses. Lawyer, GR., Jackson, M., Prinz, M., et al.[2020]

Smoking small cigars, including those with the paper liner removed (referred to as 'freaking'), leads to significant increases in heart rate and carbon monoxide (CO) exposure, indicating substantial health risks.

The study found that while nicotine boosts were higher from conventional cigarettes, CO exposure was greater from small cigars, suggesting that smoking these products still poses serious health hazards regardless of the smoking method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ad lib smoking of Black & Mild cigarillos and cigarettes. Fabian, LA., Canlas, LL., Potts, J., et al.[2022]

A study involving 44 dual users of cigarettes and either little cigars or cigarillos found that both products generate mainstream smoke (MSS) toxicants similar to those in cigarettes, indicating potential health risks.

Cigarillo smoke contained higher levels of toxicants overall compared to little cigar smoke, but when adjusted for tobacco burned, little cigars had more nicotine and certain harmful compounds, suggesting that both products pose significant health concerns and warrant FDA regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarillo and Little Cigar Mainstream Smoke Constituents from Replicated Human Smoking. Pickworth, WB., Rosenberry, ZR., Yi, D., et al.[2019]

Patients with bicuspid aortic valves (BAV) undergoing surgery for type A aortic dissection were significantly younger and had fewer cardiovascular risk factors compared to those with tricuspid aortic valves (TAV), but both groups had similar postoperative outcomes.

BAV patients had larger aortic diameters before dissection and required more aortic root replacements, indicating that BAV significantly influences the surgical approach, although most patients did not meet the criteria for elective aortic replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type A Aortic Dissection in Patients With Bicuspid Aortic Valve Aortopathy. Kreibich, M., Rylski, B., Czerny, M., et al.[2022]

In a study of 26 patients undergoing aortic valve replacement, the 19-mm St. Jude Medical HP valve showed significantly better hemodynamic performance compared to the standard 19-mm valve, with lower peak systolic pressure gradients and improved left ventricular function.

Annular enlargement in patients with small annuli resulted in the best outcomes, including a significant increase in effective orifice area during exercise, suggesting it may be particularly beneficial for those with poor heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial hemodynamic study after aortic valve replacement in patients with narrow aortic roots. Hachida, U., Koyanagi, H., Nonoyama, M., et al.[2007]

In cases of small aortic roots during surgical aortic valve replacement, it is crucial to anticipate the need for aortic root enlargement to ensure proper prosthesis fitting, as demonstrated in two patient cases.

The outcomes varied significantly between the two patients; one patient unfortunately died while the other experienced an improved quality of life, highlighting the importance of careful pre-surgical planning and consideration of potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful aortic root enlargement procedure in low resource setting: Two rare cases. Darwin, L., Pribadi, ORS.[2023]

A study of 124 families with congenital heart defects like aortic valve stenosis and coarctation of the aorta found a significant genetic component, with a relative risk of 36.9 for first-degree relatives developing similar conditions.

The research suggests a complex inheritance pattern, likely involving multiple genetic loci, which can help identify at-risk family members for early screening of heart defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inheritance analysis of congenital left ventricular outflow tract obstruction malformations: Segregation, multiplex relative risk, and heritability. McBride, KL., Pignatelli, R., Lewin, M., et al.[2020]

Aortic valve replacement can be difficult in patients with a small aortic annulus, especially after previous cardiac surgeries like the arterial switch operation for congenital heart defects.

The Konno aortoventriculoplasty technique, which is used to enlarge the aortic annulus, involves complex modifications such as pulmonary valve disruption and reconstruction of the right ventricular outflow tract, highlighting the need for tailored surgical approaches in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Konno aortoventriculoplasty following arterial switch operation requires pulmonary valve disruption and right ventricular outflow tract reconstruction. Daniel, T., Jokhadar, M., Sahu, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Double-blind trial of pergolide for Parkinson's disease. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Dopamine receptor agonists for the treatment of early or advanced Parkinson's disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pergolide mesylate and idiopathic Parkinson disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Commentary: Aripiprazole: The Second Wave of the Second-generation Antipsychotics. [2021]

5. Poland pubmed.ncbi.nlm.nih.gov

Evaluation of pulmonary side effects in prolactinoma patients treated with cabergoline. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Flavors and Risk: Perceptions of Flavors in Little Cigars and Cigarillos Among U.S. Adults, 2015. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Acute effects of cigarillo smoking. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Classification of flavors in cigarillos and little cigars and their variable cellular and acellular oxidative and cytotoxic responses. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Ad lib smoking of Black & Mild cigarillos and cigarettes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Cigarillo and Little Cigar Mainstream Smoke Constituents from Replicated Human Smoking. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Type A Aortic Dissection in Patients With Bicuspid Aortic Valve Aortopathy. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Serial hemodynamic study after aortic valve replacement in patients with narrow aortic roots. [2007]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Successful aortic root enlargement procedure in low resource setting: Two rare cases. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Inheritance analysis of congenital left ventricular outflow tract obstruction malformations: Segregation, multiplex relative risk, and heritability. [2020]

15. United States pubmed.ncbi.nlm.nih.gov

Konno aortoventriculoplasty following arterial switch operation requires pulmonary valve disruption and right ventricular outflow tract reconstruction. [2022]