No single new drug is yet FDA-approved for vaping cessation
Many people are seeking to end their dependence on nicotine-containing e-cigarettes, but as of late 2025, no medication has been specifically approved by the U.S. Food and Drug Administration (FDA) for vaping cessation. This absence of a dedicated treatment has prompted researchers to investigate both novel compounds and existing smoking cessation aids for their potential to help people quit vaping. A critical distinction exists between investigational drugs in clinical trials and established medications being used “off-label” for this purpose.
The promising investigational drug: Cytisinicline
Cytisinicline, a plant-based alkaloid, is the most advanced investigational product candidate specifically studied for vaping cessation. It works by interacting with nicotine receptors in the brain, reducing the rewarding effects of nicotine and managing withdrawal symptoms. The company developing cytisinicline has already submitted its application for FDA approval for smoking cessation and plans to pursue a vaping cessation indication as well. The FDA has granted cytisinicline Breakthrough Therapy designation for vaping cessation, a sign of its potential to address a critical unmet medical need.
Clinical trial results for cytisinicline
Recent phase 2 and 3 clinical trials have shown promising results for cytisinicline in helping adults quit vaping. For example, the ORCA-V1 trial, published in 2024, demonstrated that a 12-week course of cytisinicline combined with behavioral support led to significantly higher rates of continuous vaping abstinence compared to a placebo group.
ORCA-V1 trial highlights:
- Participants: 160 adult vapers who did not smoke cigarettes.
- Methodology: Randomized trial comparing 12 weeks of cytisinicline to a placebo, both paired with behavioral support.
- Outcome: 31.8% of the cytisinicline group achieved continuous abstinence during the final month of treatment, versus 15.1% in the placebo group.
- Tolerability: The medication was well tolerated, with relatively mild side effects.
Repurposed medication: Varenicline (formerly Chantix)
Varenicline, an existing medication previously marketed as Chantix, was widely used for smoking cessation before being withdrawn from the market due to manufacturing issues. It is now available again and is being prescribed off-label for vaping cessation with growing evidence of its effectiveness. Varenicline is also a partial agonist at nicotine receptors, which helps alleviate withdrawal symptoms and blocks nicotine from attaching to receptors, making vaping less satisfying.
Efficacy of varenicline for youth and adults
Recent studies have highlighted varenicline's potential for aiding vaping cessation across different age groups. In April 2025, a study published in JAMA revealed that varenicline was effective and safe for youth aged 16 to 25, especially when combined with behavioral support. A study from the Medical University of South Carolina (MUSC) in May 2024 also reported positive results for varenicline in adults trying to quit e-cigarettes.
Another repurposed option: Bupropion
Bupropion is another FDA-approved medication for smoking cessation that is often used off-label for vaping addiction. Marketed as Zyban for smoking cessation and as Wellbutrin for depression, this drug works by affecting neurotransmitters in the brain, helping to reduce nicotine cravings and withdrawal symptoms. It is a non-nicotine treatment that can be effective either alone or in combination with nicotine replacement therapy.
Medication comparison for vaping cessation
| Feature | Cytisinicline | Varenicline (generic) | Bupropion (generic) |
|---|---|---|---|
| FDA Approval for Vaping | Investigational (Breakthrough Therapy status) | No (used off-label based on smoking cessation approval) | No (used off-label based on smoking cessation approval) |
| Mechanism of Action | Partial agonist at nicotine receptors | Partial agonist at nicotine receptors | Affects neurotransmitters (norepinephrine, dopamine) |
| Administration | Oral pill, typically for 12 weeks | Oral pill, typically for 12 weeks | Oral pill, typically for 12 weeks |
| Key Effect | Reduces craving and withdrawal, blocks reward | Reduces craving and withdrawal, blocks reward | Reduces craving and withdrawal |
| Common Side Effects | Nausea, insomnia, anxiety, headache | Nausea, insomnia, vivid dreams | Insomnia, headache, dry mouth |
The role of behavioral support
Pharmacotherapy, regardless of the medication, is most effective when paired with behavioral support. Clinical trials for both cytisinicline and varenicline have demonstrated that counseling, whether in-person or remote, significantly improves quit rates. This integrated approach helps individuals address the psychological triggers and habits associated with vaping, reinforcing the medication's effects.
Behavioral support options include:
- Counseling: Individual or group sessions with trained professionals to develop coping strategies.
- Text Messaging Programs: Automated and personalized messages providing support and motivation, as used in recent trials.
- Telehealth Services: Remote counseling via video calls, offering accessible support for a wider population.
Conclusion: Looking toward a new era of treatment
While there is no single new, dedicated drug yet on the market, the search for an effective pharmacological solution to aid vaping cessation is making significant progress. The ongoing development of cytisinicline, bolstered by positive trial data and FDA designation, positions it as a potential future front-runner. In the meantime, existing smoking cessation drugs like varenicline and bupropion offer proven, repurposed options that have demonstrated efficacy in recent vaping-specific clinical trials, especially when combined with robust behavioral support. For anyone struggling with nicotine vaping, a conversation with a healthcare provider about these options is a crucial first step toward quitting. The combination of medication and behavioral counseling represents the most effective path forward based on current research.
Authoritative Link
For more information on quitting smoking and vaping, visit the CDC website: https://www.cdc.gov/tobacco/campaign/tips/quit-smoking/index.html
