Developing E-liquid Product Standards (Sweet Spot Study)

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05864586
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine; Nicotine Vaping; E-cigarette Use	Behavioral: Vaping study EC A; Behavioral: Vaping study EC B; Behavioral: Vaping study EC C; Behavioral: Vaping study EC D; Behavioral: Vaping study EC E; Behavioral: Vaping study EC F; Behavioral: Vaping study EC G; Behavioral: Vaping study EC H; Behavioral: Vaping study EC I; Behavioral: Vaping study EC J	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Young adult EC users Young Adult EC users	Behavioral: Vaping study EC A; Vaping two puffs using the study EC device; Behavioral: Vaping study EC B; Vaping two puffs using the study EC device; Behavioral: Vaping study EC C; Vaping two puffs using the study EC device; Behavioral: Vaping study EC D; Vaping two puffs using the study EC device; Behavioral: Vaping study EC E; Vaping two puffs using the study EC device; Behavioral: Vaping study EC F; Vaping two puffs using the study EC device; Behavioral: Vaping study EC G; Vaping two puffs using the study EC device; Behavioral: Vaping study EC H; Vaping two puffs using the study EC device; Behavioral: Vaping study EC I; Vaping two puffs using the study EC device; Behavioral: Vaping study EC J; Vaping two puffs using the study EC device
Active Comparator: Older adult smokers Adult smokers	Behavioral: Vaping study EC A; Vaping two puffs using the study EC device; Behavioral: Vaping study EC B; Vaping two puffs using the study EC device; Behavioral: Vaping study EC C; Vaping two puffs using the study EC device; Behavioral: Vaping study EC D; Vaping two puffs using the study EC device; Behavioral: Vaping study EC E; Vaping two puffs using the study EC device; Behavioral: Vaping study EC F; Vaping two puffs using the study EC device; Behavioral: Vaping study EC G; Vaping two puffs using the study EC device; Behavioral: Vaping study EC H; Vaping two puffs using the study EC device; Behavioral: Vaping study EC I; Vaping two puffs using the study EC device; Behavioral: Vaping study EC J; Vaping two puffs using the study EC device

Outcome Measures

Primary Outcome Measures

1. Behavioral Intentions for continued use [1 hour]

   The self-report measure on a 7-point scale will be completed following e-cigarette self-administration.

2. Intensity of sensory attributes [1 hour]

   The 5-item self-report measure will be completed following e-cigarette self-administration, using the general Labeled Magnitude Scale.

3. Degree of liking or disliking of sensations [1 hour]

   The self-report measure will be completed following e-cigarette self-administration, using the Labeled Hedonic Scale.

Secondary Outcome Measures

1. Subjective Appeal [1 hour]

   The 11-item modified Cigarette Evaluation Questionnaire (mCEQ) will be completed following e-cigarette self-administration.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Theodore L Wagener, PhD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Jamesline

Publications

None provided.

• Responsible Party: Theodore Wagener, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT05864586
• Other Study ID Numbers: OSU-22253; NCI-2023-03206
• First Posted: May 18, 2023
• Last Update Posted: May 18, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 18, 2023