Mass. General Hospital Director Of Tobacco Research & Treatment Center, Dr. Nancy Rigotti, MD talks about a new way for vaping participants to quit.
Interview conducted by Ivanhoe Broadcast News in 2022.
We’re talking about vaping. From your perspective, has this become, I hate to say it this way, but the new cigarette?
RIGOTTI: No, it’s not the new cigarette. It’s very different than a cigarette. It may look a little bit like a cigarette because it’s something that you hold in your hand, you put in your mouth. You inhale and exhale and it gives you some of- it gives people who are smokers, some of the pleasures that they had from smoking. There’s nothing burned. A cigarette burns tobacco, and then people inhale it and it’s the products of burning, not the nicotine is what kills people. The nicotine keeps people smoking, but it’s the other stuff in cigarettes that kills them. Whereas for e-cigarettes, they’re different. They are products that simply heat up a liquid that includes nicotine, but often also flavorings.
How is vaping different?
RIGOTTI: Vaping is different. What it is is it’s a device that has a liquid that includes nicotine and flavorings and some other things. It’s heated and it creates a vapor that the user inhales, but nothing is burned. You’re inhaling nicotine and the solvent basically. You’re not exhaling smoke even though it may look like that.
Was the original intent of vaping to help people kick the habit of nicotine to help keep smoking?
RIGOTTI: Vaping was invented by a Chinese pharmacist who was a smoker and had trouble quitting. He came up with this device that didn’t burn tobacco but gave him the nicotine. It was initially developed as a way of reducing the harms from smoking and ideally helping people to quit smoking entirely by using a less risky device. That was the original plan. In fact, it does work to do that. People who have quit smoking by switching over vaping have clearly reduced their risk. There’s no question about it. Vaping devices do help people quit smoking as long as they use them regularly.
Has vaping morphed into something else?
RIGOTTI: Yes, it has. What happened was that the products like Juul came along and the Juul product was a better device because it delivered nicotine in a way that allowed people to get a higher dose of nicotine without it irritating their throat. It gave them more of the pleasures of smoking without getting irritated. It also was small and looked like a cool device. The company that made it marketed it in a way that was attractive to kids. What happened was we develop this essentially kind of epidemic of young people picking up this device that wasn’t intended for them, even though it was marketed in a way that attracted them, but was not intended for them. There was no reason for them to use it. There really is no reason for people to be using a vaping device if they’re not a smoker trying to quit.
Is there is harm in these devices?
RIGOTTI: Using e-cigarettes is not harmless. There are probably some harms. We don’t fully know them at this point, but we know that- that compared to smoking, it’s so much less harmful. There’s no question. If only smokers were the people using it, that would be a great product. That is why I who try to help people quit smoking, was so excited when they first came. It is just an enormous frustration that young people who were not the intended users of these devices picked it up and then they became nicotine addicted to certain amounts more or less. Then, as the devices got better at delivering nicotine, they were more addictive for kids. Now, there’s a lot of people who are smoking, who are young adults where about 9 million adults are smoking. About one in 10 young adults, 18 to 24 year-olds are now vaping. Many of them never smoked. Some of them did smoke and switched, but many of them never smoked. A lot of them are saying, I want to quit. Maybe for financial reasons, maybe for reasons that they’re concerned about the health effects, and so forth because they’re hearing about them. Some of them are able to quit, but a lot of them are having trouble. That’s where we got involved in the study that we’re doing now.
Is it the teens who are inhaling that nicotine? Is the nicotine the addictive?
RIGOTTI: Yes. The e-cigarettes are addictive because they contain nicotine. It’s the nicotine that’s addictive. Nothing else that’s in the cigarette- nothing else in the e-cigarette is addictive.
You actually have teens and young adults coming to you?
RIGOTTI: I’m an adult internist, so I take care of adults and I do have young adults that we are seeing who need help quitting.
How do you help people quit?
RIGOTTI: We don’t really know what to do to help people quit vaping because it is such a new problem. Due to it being a nicotine addiction and smoking is a nicotine addiction, we use the techniques that we use for smoking cessation with folks who are trying to stop vaping, whether they’re effective or not, we really don’t know. We hope that they will be in that they’re safe because we’re already using them for smokers. But we don’t know. We use medicines, we use text messaging programs, telephone counseling, all of the same things that we use for smoking.
What’s on the horizon?
RIGOTTI: We are trying something a little different. We’re trying a new medicine to try to help vapors quit. This is a medicine that has been available in Eastern Europe for decades as a smoking cessation aid. It’s never been approved in the United States for smoking cessation. It’s not used here or in Europe and in Western Europe. We are trying to see if we can get an FDA approval to have it sold as a new product for smoking cessation. We did a trial and it was very effective. We’re enrolling people in a study where everyone will get some behavioral support to quit smoking, and then they will either get the active drug, which is actually a natural product that grows on trees in Eastern Europe. It’s a plant-based natural product, or they’ll get a placebo which is an identical pill, and they’ll take it for 12 weeks. Then we’re going to measure whether or not they’re able to stop vaping at the end of 12 weeks and then follow them for a few more weeks and see if they were able to stop if they could stay stopped.
What is the name of the plant-based product and how you said take it?
RIGOTTI: It’s a pill that’s taken three times a day.
What’s it called?
RIGOTTI: Well, the plant product was called Cytisinicline.
Is it plant-based?
RIGOTTI: The plant-based nature is attractive to a lot of young people who really don’t like taking pills. When you think of young adults, they don’t take pills unless they are taking pills for contraception, for example, but young adults are healthy, so they’re not used to taking pills and often would prefer not to.
Are there any less side effects from taking this plant-based?
RIGOTTI: Every drug has side effects, but these seem to be tolerated. The main side effects are some nausea, sometimes headache, and these vivid dreams, which are- people describe them as technicolor. Some people like them, some people don’t like them. We’re not seeing a lot of it. The drug itself is very similar to one of our smoking cessation medicines that’s called varenicline or Chantix. It has a similar effect, but it has fewer side effects is what we’re seeing. It’s much better tolerated. Plus a lot of people are afraid of using Chantix because it shouldn’t be. But for a while, when it first came out, there was a lot of concern that it might have serious psychological effects. In fact, it doesn’t, and it’s very effective for smoking cessation. It’s our best single drug. We’re hoping that this new medicine will have the same benefits and perhaps fewer side effects.
What are the implications for having one more tool for something that is so difficult for so many people?
RIGOTTI: It would be enormously helpful for us if we had another tool to help smokers quit. We haven’t had a new drug appear for more than 10 years. The last one was in 2006. Now we’re learning how to combine the drugs we have and do things better, but we need new medications to help people quit. There are people who have not been able to succeed with the products that we have.
How many people do you anticipate to enroll over what period of time before you start seeing some data?
RIGOTTI: The trial is a pilot study. A pilot randomized controlled trial. It is 150 people who are vapors only can’t be still smoking. They have to be vapors only. They can be former smokers, but not currently smoking. Despite vape every day, and they take the medicine, as I said, for three times a day for 12 weeks. Then we follow them for another three- another 12 weeks.
Three times a day for 12 weeks, and then you follow them?
RIGOTTI: For another, it is an additional 12 weeks. We started enrolling in July of 2020. We expect to be finished with our enrollment at the end of October of 2020. We are expecting to see results in about next summer.
What pushes it to the next level where it could potentially be a person who has to be FDA approved?
RIGOTTI: Yes, it would have to be FDA approved. First it has a separate IND investigational new drug application than the smoking, but the company will go after the smoking one first. First they will because they’re further along in development, that’s-they’re closer to getting that one approved. Then, as soon as that’s approved, they would get this one. They would work on getting this one approved. It would be the first medication that is approved for vaping cessation because it’s so new no other companies have developed or gotten this approval.
How close are they if it’s not approved yet for smokers?
RIGOTTI: For smokers, the FDA has required them to do two large 800 percent trials, and they finished one that I ran for them, and that one was very encouraging. The second one just finished its recruitment. So we are expecting it by next spring, early summer, we’ll have the data that the company can then take to the FDA to ask for permission to sell the drug commercially. That process probably takes six or nine months. They’re anticipating it coming out in 2024.
For smokers?
RIGOTTI: For smokers and maybe for vapors not long after that. It does sound like a long time away, but it isn’t that anymore. That would be great because we’re still losing 500,000 people a year to smoking and we don’t have great medications. We have medications that are effective, but they don’t help everybody. If we could get another tool, that would be terrific.
END OF INTERVIEW
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