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NCT05864586 Clinical Trial

Developing E-liquid Product Standards (Sweet Spot Study)

E-cigarette Use Clinical Trial

Official title:
Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05864586
Other study ID # OSU-22253
Secondary ID NCI-2023-03206
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date December 31, 2024

Study information
Verified date June 2023
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Sweet Spot Study aims to evaluate the effect of e-liquids with nicotine varying in freebase (FB) levels and concentrations on the appeal of electronic cigarettes (ECs) in young adult EC users with minimal/no history of smoking and older adult smokers.

Recruitment information / eligibility
Status Recruiting
Enrollment 132
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 50 Years
Eligibility Inclusion criteria: 1. Young adult e-cigarette user or older adult smoker 2. Willing to abstain from all nicotine product use for 12 hours prior to the study visit 3. Read and speak English Exclusion criteria: 1. Currently attempting to quit nicotine products 2. Currently pregnant, planning to become pregnant, or breastfeeding 3. Current or past use of tobacco products other than e-cigarettes or cigarettes 4. Self-reported diagnosis of lung disease 5. Self-reported new or unstable cardiovascular disease

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Vaping study EC A
Vaping two puffs using the study EC device
• Vaping study EC B
Vaping two puffs using the study EC device
• Vaping study EC C
Vaping two puffs using the study EC device
• Vaping study EC D
Vaping two puffs using the study EC device
• Vaping study EC E
Vaping two puffs using the study EC device
• Vaping study EC F
Vaping two puffs using the study EC device
• Vaping study EC G
Vaping two puffs using the study EC device
• Vaping study EC H
Vaping two puffs using the study EC device
• Vaping study EC I
Vaping two puffs using the study EC device
• Vaping study EC J
Vaping two puffs using the study EC device

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Behavioral Intentions for continued use The self-report measure on a 7-point scale will be completed following e-cigarette self-administration. 1 hour
Primary Intensity of sensory attributes The 5-item self-report measure will be completed following e-cigarette self-administration, using the general Labeled Magnitude Scale. 1 hour
Primary Degree of liking or disliking of sensations The self-report measure will be completed following e-cigarette self-administration, using the Labeled Hedonic Scale. 1 hour
Secondary Subjective Appeal The 11-item modified Cigarette Evaluation Questionnaire (mCEQ) will be completed following e-cigarette self-administration. 1 hour
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Active, not recruiting NCT03491059 - Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use Phase 4
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Recruiting NCT05458895 - Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth N/A
Enrolling by invitation NCT05140915 - Vaper to Vaper: A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping N/A
Active, not recruiting NCT04843501 - Middle School Cluster Randomized Controlled Trial (RCT) to Evaluate E-Cigarette Prevention Program: CATCH My Breath N/A
Recruiting NCT06027840 - Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use Phase 1

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