A clinical trial to test whether three proven smoking cessation treatments could also reduce alcohol consumption found no difference between the drugs, but behavior change rates for alcohol consumption and smoking were high in all treatment groups. The results suggest that these drugs could play an important role in reducing alcohol consumption and smoking at the same time. Unexpectedly, nicotine replacement therapy was as effective as the prescription drugs varenicline and cytisine.
The study, published August 5 in Open JAMA Network, involved 400 people living with HIV in Russia and was designed by researchers from Vanderbilt University Medical Center (VUMC), Boston University School of Medicine, Boston Medical Center and First Pavlov State Medical University in St. Petersburg, Russia. Investigators, who included addiction specialists and HIV researchers, recruited volunteers who identified themselves as engaging in risky drinking and daily smoking. Participants were followed for up to 12 months after enrollment in the clinical trial. The drugs were placebo-controlled, so participants and investigators did not know who was assigned to which drug.
The study showed that after three months, alcohol consumption decreased whether participants received nicotine replacement therapy, varenicline or cytisine. The primary outcome was the number of heavy drinking days in the previous month at three months, and secondary outcomes included abstinence from alcohol at three months and abstinence from smoking at six months. .
“A single drug to treat both alcohol use and risky smoking could effectively and significantly improve health. Alcohol use and risky smoking frequently coexist, and they both threaten health by increasing the risk of cardiovascular disease, cancer and other important health problems,” the study said. lead author, Hilary Tindle, MD, MPH, William Anderson Spickard, Jr., MD, Professor of Medicine and Associate Professor of Medicine at VUMC. “
Researchers are increasingly focusing on comorbidities in people living with HIV, such as cardiovascular disease and cancer, to improve their longevity, as there are now effective treatments for the virus.
“It was gratifying to see high-risk research participants included in NIH-funded research,” he said. Matthew Freiberg, MD, MSc, the study’s principal investigator, Dorothy and Laurence Grossman Professor of Cardiology, and professor of medicine at VUMC. “Not only are they living with HIV, but they also have a heavy burden of hepatitis, multiple substance use and mental health issues. These participants are often excluded from drug trials. If something as simple as nicotine replacement could help them, that would be a win.”
Freiberg noted that when the investigators designed the study, they envisioned nicotine replacement as the “control” arm for alcohol use. Nicotine replacement therapy has been available in the United States to treat tobacco addiction since the early 1980s and is not used to reduce alcohol consumption.
The study recruited participants who engaged in five or more binge drinking days in the previous month (defined as five or more drinks in one day for a male or four or more drinks in one day for a female). woman) and who smoked five or more cigarettes a day. daytime.
The VUMC researchers worked with Jeffrey Samet, MD, MA, MPH, John Noble, MD, professor of general internal medicine and professor of community health sciences at Boston University Schools of Medicine and Public Health, and study colleague. Samet’s research focuses on drug addiction and HIV infection.
Another important observation in our post-hoc analysis was that rates of alcohol consumption were lower and rates of abstinence from alcohol were higher among people who quit smoking compared to those who continued to smoke. to smoke. These findings require further study to understand whether the results were due directly to the medications, smoking cessation, or both.”
Jeffrey Samet, Study Lead Author, Boston University Schools of Medicine and Public Health
Tindle added that there is a lot to learn about how the drugs in the study – called nicotinic acetylcholine receptor agonists – can work to reduce voluntary alcohol consumption. Studies in animal models show that stimulation of a very specific type of receptor containing the alpha four subunit is required. Importantly, all three study drugs target these same receptors.
The investigators concluded that the results of the study, which was conducted from July 2017 to December 2020, extend previous work in several ways. Notably, it is the largest trial to study nicotinic acetylcholine receptor partial agonists to target alcohol consumption and the first to examine cytisine to treat both alcohol and tobacco. Cytisine is not yet approved by the US Food and Drug Administration to treat smoking, but it has been widely used in Eastern Europe for decades and is actively studied around the world.
The study received funding from the National Institute on Alcohol Abuse and Alcoholism in support of the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS, at the Providence/Boston Center for AIDS Research and at the Tennessee Center for AIDS Research.
Vanderbilt University Medical Center
Tindle, HA, et al. (2022) Effectiveness of varenicline and cytisine in reducing alcohol consumption in people living with HIV and drug users. Open JAMA Networkdoi.org/10.1001/jamanetworkopen.2022.25129.