Ongoing Clinical Trials for Electronic Cigarette Users
Currently, there is 1 ongoing clinical trial focused on helping people quit using electronic cigarettes. This trial is testing cytisine, a medication designed to support cessation of both electronic cigarettes and tobacco cigarettes in motivated individuals. The study is being conducted in Poland and includes behavioral support alongside the investigational treatment.
Clinical trial locations
Study on Cytisine for Quitting Nicotine E-Cigarettes and Tobacco in Motivated Individuals
This clinical trial is designed to help people who want to quit using nicotine-containing electronic cigarettes and tobacco cigarettes. The study tests whether cytisine, a medication given in tablet form, can effectively support cessation when combined with behavioral support.
Main inclusion criteria:
- Must be at least 18 years old
- Must be willing to follow all study requirements and complete all procedures
- Must provide a valid mobile phone number and email address, and have daily access to a mobile phone
- For single electronic cigarette users: must use nicotine-containing electronic cigarettes daily or at least five days per week for at least one month, with no tobacco use in the past three months (verified by a carbon monoxide breath test showing 5 parts per million or less)
- For dual users: must use nicotine-containing electronic cigarettes daily or at least five days per week for at least one month, and smoke at least one tobacco cigarette per day (verified by a carbon monoxide breath test showing greater than 5 parts per million)
- Must be willing to attempt quitting using the study products
- Women of childbearing potential must use highly effective birth control methods during the study (such as birth control pills, implants, IUDs, or barrier methods)
- Men must use barrier contraception and ensure their partners use effective birth control
Main exclusion criteria:
- Individuals who are not motivated to quit vaping or smoking
- Individuals outside the specified age range
- Those who do not meet the required health criteria
- Individuals unable to follow study procedures or take the study medication as required
- Members of vulnerable populations not intended for inclusion
Focus and goal of the trial:
The study aims to evaluate whether cytisine is more effective than placebo in helping people quit using both electronic cigarettes and tobacco cigarettes. Participants are randomly assigned to receive either cytisine tablets or placebo tablets for 12 weeks, with both groups receiving behavioral support throughout. The trial monitors participants for 30 weeks to determine if they can remain smoke-free and vape-free. Success is measured by biochemically verified continuous abstinence from electronic cigarettes and tobacco cigarettes for 26 weeks before the 30-week follow-up. Testing includes urine tests for cotinine and NNAL, substances that indicate recent nicotine use.
Investigational drug:
The medication being tested is cytisine, given as 1.5 mg tablets taken orally for 12 weeks. Cytisine works by binding to nicotinic acetylcholine receptors in the brain, which helps reduce withdrawal symptoms and cravings associated with nicotine addiction. It acts as a partial agonist, meaning it partially activates these receptors while blocking nicotine from binding to them. This mechanism is designed to ease the quitting process by managing the physical symptoms of nicotine withdrawal.
Summary
Currently, there is one clinical trial available for individuals seeking to quit using electronic cigarettes. This trial is being conducted in Poland and focuses on testing cytisine, a cessation medication, combined with behavioral support. The study includes both exclusive electronic cigarette users and those who use both electronic and tobacco cigarettes. The trial represents an important step in understanding whether existing smoking cessation medications can be effective for those seeking to quit vaping, a relatively new area of research given the recent rise in electronic cigarette use. Participants must be motivated to quit and willing to commit to a 30-week study period that includes regular monitoring and biochemical verification of abstinence.