Comparative Evaluation of Nicotine Analogs
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorOhio State University Comprehensive Cancer Center
About this trial
This phase I trial compares electronic cigarette (EC) user preferences and smoking behaviors of nicotine analogs to nicotine to improve the understanding of nicotine analog addictiveness. Over the last ten years, EC use has become a major concern due to its increased use among adolescents and young adults. Though progress has been made in regulating nicotine containing products, some companies have shifted toward producing products containing nicotine analogs. ECs are battery-powered electronic devices designed to atomize a nicotine (the poisonous chemical found in tobacco)-containing liquid solution for inhalation in a manner that simulates smoking a tobacco cigarette. When nicotine enters the body, it causes an increased heart rate and use of oxygen by the heart, and a sense of well-being and relaxation. Nicotine analogs are compounds that are similar to nicotine in their chemical structure. Some nicotine analogs have been shown to have nicotine-like effects; however, more research is needed to prove they function similarly to nicotine and/or have similar effects. Comparing EC user preferences and smoking behaviors of nicotine analogs to nicotine may help improve the understanding of nicotine analog addictiveness.
Additionally, combustible cigarette smoking is well-known to have deleterious effects on cardiovascular health. High blood pressure is one of the major health consequences of cigarette smoking and can increase the risk of hypertension, heart attack, and stroke. Although ECs have been marketed as a less harmful alternative to cigarette smoking, clinical trials have shown that vaping ECs can also lead to acute increases in blood pressure and heart rate. Nicotine can alter vascular reactivity by promoting the release of vasoconstrictors and suppressing the production of vasodilators. No research has examined how the synthetic nicotine in ECs affects hemodynamics, vascular health, and endothelial function. Assessing acute cardiovascular responses to nicotine analogs is therefore critical to enhancing our understanding of the potential cardiovascular risks associated with vaping ECs containing synthetic nicotine.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 21 years or older
Current adult EC user for at least the past 3 months (confirmed by cotinine testing strip)
Willing and able to provide informed consent
Willing to abstain from using any nicotine, tobacco, or marijuana products for 12 or more hours prior to the three lab visits
Disqualifiers
Currently attempting to quit nicotine or tobacco products
Use of other tobacco or nicotine products > 10 days in the past month
Have had a recent cardiac event or distress (defined as occurring within the previous 3 months)
Have had a recent serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, asthma, or lung cancer) (defined as occurring in the previous 30 days)
Trial design
Design model
Crossover
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo urine and blood sample collection
Nicotine
DrugUse nicotine EC
6-Methyl Nicotine
DrugUse 6-MN EC
nicotinamide
DrugUse nicotinamide EC
Puffing Topography Research
BehavioralAncillary studies
Survey Administration
Other interventionAncillary studies
Cardiovascular effects
Procedure/SurgeryCardiovascular effects will be measured using hemodynamic responses (i.e., blood pressure, pulse pressure, mean arterial pressure), arterial stiffness (i.e., central augmentation index), and endothelial function (i.e., plasma levels of endothelin-1, 6-keto-PGF1α, and nitric oxide metabolite).
Treatment groups
70 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Sequence 1 (nicotine, 6-MN, nicotinamide)Experimental treatment 7 interventions
Group B: Sequence 2 (nicotine, nicotinamide, 6-MN)Experimental treatment 7 interventions
Group C: Sequence 3 (nicotinamide, 6-MN, nicotine)Experimental treatment 7 interventions
Group D: Sequence 4 (nicotinamide, nicotine, 6-MN)Experimental treatment 7 interventions
Group E: Sequence 5 (6-MN, nicotine, nicotinamide)Experimental treatment 7 interventions
Group F: Sequence 6 (6-MN, nicotinamide, nicotine)Experimental treatment 7 interventions
Trial outcomes
Primary outcomes
1
Nicotine urges/craving (QSU)
E-cigarette (EC) urges/craving will be measured with a modified version of the 10-item Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU). Words such as "cigarette" and "smoke" are replaced with words such as "e-cigarette" and "vape." Each of the 10 items is scored on a 7 point Likert scale. Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to smoke.
Time frame
Before puffing (0 minutes), and at 5, 15, 65, 95, and 125 minutes after the start of the puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)2
Nicotine withdrawal symptoms (MNWS)
The 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS) will be used to measure nicotine withdrawal symptoms. Items are rated on a 5-point scale from 0 (none) to 4 (severe) where higher scores indicate a greater experience of withdrawal symptoms.
Time frame
Before puffing (0 minutes), and at 5, 15, 65, 95, and 125 minutes after the start of the puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)3
Economic demand indices (E-CPT)
Consumer demand as measured by the E-Cigarette Purchase Task (E-CPT) will be used to measure economic demand. Participants will report the volume (mLs) or puffs of e-liquid they would be willing to purchase and use within 24 hours at a given price, which will incrementally increase from $0 to $1,120.
Time frame
After completion of the 60 minute ad lib puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)Secondary outcomes
1
Modified EC evaluation questionnaire (mCEQ)
The modified EC Evaluation Questionnaire (mCEQ) will be used to measure sensory effects, affective responses, and other subjective responses (e.g., reward, satisfaction). The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction.
Time frame
After completion of the 60 minute ad lib puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)2
Use topography: Inter-puff-interval
The average time between each puff for each participant, in seconds.
Time frame
60 minute puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)3
Use topography: Puffing duration
Average puff duration for each participant, in seconds.
Time frame
60 minute puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)4
Use topography: Total puff volume
The total volume of all puffs taken for each participant, in mL.
Time frame
60 minute puffing session; at Visit 1 (baseline), Visit 2 (≥ 48 hours after the previous visit), and Visit 3 (end-of-study visit; ≥ 48 hours after the previous visit)Sponsors and contacts
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Source ClinicalTrials.gov