This news release describes a report on an ongoing trial of the Alzheimer’s drug galantamine as a smoking cessation aid. The release also notes that the study on which it’s based sought to explore whether the drug would have less of an effect on participants’ “executive functions” while going through withdrawal than other methods since many people in the process of giving up tobacco experience forgetfulness and “fuzziness,” according to the release. The release does a good overall job of describing the researchers’ long-range thinking and goals with the study, and the release is clear that this approach could have downsides and side effects. The release would have been stronger had it talked about about costs and discussed how this approach compares with the alternatives.
Simply stated, cigarette smoking has been found to have ill effects on almost every organ of the body. Despite decades of research and laws banning cigarette advertising people still have a hard time giving up this habit. Few people who try to quit are successful on the first try, and it’s not uncommon for people to try several different methods before they can quit for good. This study focuses on one of numerous clinical trials that explore interfering with the brain’s response-reward systems as a way to combat addiction. Re-purposing Alzheimer’s disease drugs as a potential new tool in the smoking cessation tool chest is newsworthy.
There is no mention of costs in the release. Some mention of costs would have been useful and could have taken a number of different forms such as how the cost of these drugs would compare to buying cigarettes on a daily basis, comparing the drug price to other tools for quitting smoking, or providing cost estimates of treating smoking-related diseases.
The release may overstate things in the headline which claims, “An FDA-approved Alzheimer’s drug could help smokers quit.” The study didn’t look at quit rates and lasted only 23 days, so the effect on quitting is entirely unknown. We’ll give the benefit of the doubt here though since the release notes that people involved in the trials (there was also an animal trial component) reduced their cigarette use by 2.3 cigarettes a day — a 12% decrease — after being on the drug for two weeks. The volunteers also related that they felt “less satisfied” with smoking after being on the drug, although this benefit was not quantified.
The release notes that people may become ill when taking the AD drugs. A source is quoted in the release says, “We know from the literature that upward of 30 percent of patients will report nausea and vomiting [when taking these drugs], and that this will limit their compliance.”
The news release gives a fairly clear description of the study parameters. The study, while small with 33 volunteers, involved giving the still-smoking participants either the drug galantamine or a placebo for two weeks and then asked them to refrain from smoking for one week while on either their prescribed galantamine or placebo. The researchers measured cognitive abilities at baseline and after two weeks on the drug to determine if the drug helped reduce side effects people normally encounter while withdrawing off tobacco.
The release is clear that much more evidence will be available, including on overall quit rates (the most important and relevant outcome), when the full study is completed. There is really not much of a take-away at this point as the information is so incomplete.
It would be difficult to overstate the harms of cigarette smoking. The release does not engage in fear mongering.
The release doesn’t explicitly state who funded the study or if there were any conflicts of interest. However, it’s strongly inferred that Penn’s Center for Interdisciplinary Research on Nicotine Addiction is the main sponsor. The study itself states that the research received funding from several government and non-profit research organizations and that there were no conflicts of interest. This is not a major omission but must be rated Not Satisfactory.
The release nods briefly to the existence of other medications for smoking cessation and how galantamine would differ.
“Our goal in investigating these different repurposed medications is not to replace the medications that are already available,” she said. “We know that they’re effective. Our goal is to target different populations of smokers who may be more likely to experience these cognitive deficits.”
Although it doesn’t specifically mention any other smoking cessation tools and techniques by name or discuss how successful galantamine might be in comparison, we’ll give the benefit of the doubt.
The story states that galantamine is FDA approved which speaks to its availability. The release responsibly points out that “There’s no data to suggest that a clinician treating a smoker should prescribe one of these AChEIs now,” according to the lead investigator.
The news release makes a tepid reference to novelty with the phrase that researchers are “forging a path” with this research. The study itself says, “To the best of our knowledge, this is the first translational study to demonstrate that repeated AChEI administration decreases nicotine taking in both rats and human smokers.”
While this may well be the first “translational” study on this question, a look on PubMed shows that quite a lot has been done in rats on nicotine and the cholinesterase inhibitor drugs. There has been much less in humans, although trials have been done, with mixed success, such as this modestly successful one in alcoholics. (A randomized, controlled trial in 114 patients for 12 weeks, it showed those on galantamine smoked 20% fewer cigarettes than those on placebo.) To earn a Satisfactory rating, we think the release should have acknowledged some of this previous research.
There was no reliance on unjustifiable language.