Concentration Impact Nicotine Salt

NCT04725656 | Recruiting

• 1 other identifier: BASEC-ID: 2020-01875
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind (for the two active arms), randomized, three-arm (two active and one control) clinical trial investigating factors (e.g. nicotine concentration) influencing the success of smoking cessation strategies and possible health risks related to nicotine salt vaping.

Conditions

Smoking Cessation; Vaping

Outcome Measures

Primary Outcomes (2)

• 7-day point prevalence tobacco abstinence (in terms of non-inferiority)

  Defined as no smoking, i.e. "not a puff", self-reported and confirmed by exhaled carbon monoxide (\<10 ppm) and urinary anabasine levels (\<3 ng/mL) when using low vs. high nicotine salt concentration e-liquids.

  1 month

• Volume of e-liquid used (in terms of superiority)

  Volume of e-liquid used when using low vs. high nicotine salt concentration e-liquids.

  1 month

Secondary Outcomes (15)

• 7-day point prevalence tobacco cigarette abstinence

  1 month

• Continuous tobacco cigarette abstinence

  1 month

• 7-day point prevalence tobacco cigarette abstinence

  3 and 6 months

• Continuous tobacco cigarette abstinence

  3 and 6 months

• Number of drop-outs

  Through study completion

Study Arms (3)

Active arm, low concentration (18 mg/mL) nicotine salt e-liquids

ACTIVE COMPARATOR

Procedure: Smoking cessation counseling; Other: Open system vape device and nicotine salt e-liquids

Active arm, high concentration (59 mg/mL) nicotine salt e-liquids

ACTIVE COMPARATOR

Procedure: Smoking cessation counseling; Other: Open system vape device and nicotine salt e-liquids

Control group

OTHER

Receive only smoking cessation counseling

Procedure: Smoking cessation counseling

Interventions

Smoking cessation counseling PROCEDURE

Smoking cessation counseling at baseline, week 1, and week 4.

Active arm, high concentration (59 mg/mL) nicotine salt e-liquids; Active arm, low concentration (18 mg/mL) nicotine salt e-liquids; Control group

Open system vape device and nicotine salt e-liquids OTHER

Ad libitum use of nicotine salt e-liquids during three months.

Active arm, high concentration (59 mg/mL) nicotine salt e-liquids; Active arm, low concentration (18 mg/mL) nicotine salt e-liquids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years old) smokers (at least 5 TC per day for at least 12 months)
• Motivated to quit smoking as evidenced by signing the informed consent form at trial enrolment specifying that a target quit date will be set
• Exhaled CO ≥ 10 ppm or saliva cotinine of \> 30 ng/ml (in case of borderline CO measurement of 6-10 ppm) at screening
• Willing to participate in the trial even if allocated to the control group
• Ability to communicate well with the investigator and to understand and comply with the requirements of the study
• Signed informed consent form

You may not qualify if:

• Known hypersensitivity/allergy to a content of the e-liquid
• Pregnancy or breast feeding
• Intention to become pregnant during the course of the study
• Current regular use of EC or tobacco heating systems
• Use of NRT, varenicline, or bupropion in the month prior to the screening visit
• People who smoke tobacco combined with marijuana and do not currently want to quit marijuana use
• Participation in an interventional trial within 30 days prior to the screening visit
• Legal incapacity or limited legal capacity at screening
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Inselspital

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Officials

• Evangelia Liakoni, MD

  Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evangelia Liakoni, MD

CONTACT

0041316325461; evangelia.liakoni@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 27, 2021
• Study Start: January 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)