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Nicotine Salt

Nicotine Salt-Based Vaping for Nicotine Addiction

N/A
Recruiting
Led By Amanda Quisenberry
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has used ENDS product or e-liquid containing nicotine (by history)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is studying the effects of nicotine salt-based vaping products compared to products with free-base nicotine.

Who is the study for?
This trial is for current daily users of ENDS (electronic nicotine delivery systems) who have been using these products every day for at least the past 6 months. Participants must be willing to avoid using their vaping device overnight before study visits and cannot be pregnant, nursing, or smoke more than five cigarettes a month. They should not have unstable medical conditions or psychiatric issues that could affect their participation.Check my eligibility
What is being tested?
The SALTVAPE Study is examining how different types of nicotine in vaping products—nicotine salts versus free-base nicotine—affect the levels of nicotine in the bloodstream over time. It also looks at personal experiences and potential misuse risks associated with these products.See study design
What are the potential side effects?
While specific side effects are not listed, typical reactions to nicotine include nausea, headache, increased heart rate/blood pressure, dizziness, throat/mouth irritation and coughing. Serious side effects from previous use of nicotine or replacement therapies exclude participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have used nicotine e-cigarettes or e-liquids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve (AUC)
Maximum concentration of nicotine in plasma (Cmax)
Time to maximum concentration
Secondary outcome measures
Change in nicotine withdrawal symptoms
Subjective measure of perceived harshness of nicotine withdrawal symptoms
Subjective measure of perceived liking of nicotine withdrawal symptoms
+1 more
Other outcome measures
Demand indices including intensity and elasticity of demand for each device sampled
Substitution levels of alternative tobacco products

Side effects data

From 2014 Phase 4 trial • 127 Patients • NCT01400243
65%
Any nonserious adverse event
22%
Itchiness at Patch Site
16%
Nausea
8%
Redness at patch site
5%
Headache
5%
Decreased appetite
2%
Lucid dreams
2%
Hot or sweating
2%
Lightheadedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nicotine Patch
Placebo Patch

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low Nicotine (nicotine vapor) 24 mg.mlExperimental Treatment2 Interventions
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours, 5-7 days apart. During each session, participants take 20 puffs over 10 minutes (one puff every 30 seconds) of vaporizer filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
Group II: High Nicotine (nicotine vapor) 42 mg.mlExperimental Treatment2 Interventions
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours, 5-7 days apart. During each session, participants take 20 puffs over 10 minutes (one puff every 30 seconds) of vaporizer filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
2005
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,692 Previous Clinical Trials
40,929,856 Total Patients Enrolled
1 Trials studying Nicotine Addiction
20 Patients Enrolled for Nicotine Addiction
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
31,106 Total Patients Enrolled
Amanda QuisenberryPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
103 Total Patients Enrolled

Media Library

Nicotine Salt-Based Vaping Products (Nicotine Salt) Clinical Trial Eligibility Overview. Trial Name: NCT04231539 — N/A
Nicotine Addiction Research Study Groups: High Nicotine (nicotine vapor) 42 mg.ml, Low Nicotine (nicotine vapor) 24 mg.ml
Nicotine Addiction Clinical Trial 2023: Nicotine Salt-Based Vaping Products Highlights & Side Effects. Trial Name: NCT04231539 — N/A
Nicotine Salt-Based Vaping Products (Nicotine Salt) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04231539 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation rate in this clinical experiment?

"Affirmative. The particulars of this medical experiment, which were initially posted on February 18th 2020, are accessible via clinicaltrials.gov and demonstrate that recruitment is still ongoing. 20 individuals need to be recruited from 1 site in order for the study to reach completion."

Answered by AI

What are the desired outcomes of this research?

"The primary measure of efficacy for this trial, estimated to take up to 2 hours, is the Maximum concentration of nicotine in plasma (Cmax). Other secondary objectives include Subjective measures such as Product Evaluation Scales and Minnesota Nicotine Withdrawal Scale."

Answered by AI

Are there any vacant slots available for this research protocol?

"According to clinicaltrials.gov, this medical trial is ongoing and actively recruiting patients since its inception on February 18th 2020. The study's most recent update was July 25th 2022."

Answered by AI

Have researchers conducted any other investigations involving Nicotine?

"Currently, 71 research studies regarding Nicotine are ongoing. 5 of those trials have reached Phase 3 and the majority of them originate in Greenville, South carolina. However, a total of 204 sites across the country offer these treatments."

Answered by AI

To what extent is enrollment in this experiment open to the public?

"This research trial is recruiting 20 subjects, aged 21 to 55 that display signs of nicotine dependence. Furthermore, participants must be current users of electronic nicotine delivery systems (ENDS)."

Answered by AI

Is there an age limit when considering participants for this experiment?

"For enrolment in this trial, participants must be between the ages of 21 and 55."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study
2020. "Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04231539.
~1 spots leftby Aug 2024
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