Study that investigated whether three smoking

Image: Hilary Tindle, MD, MPH, de William Anderson Spickard, Jr., MD, professor of medicine and associate professor of medicine at VUMC
vision Lake

Credit: Vanderbilt University Medical Center

A clinical trial to test whether three proven smoking cessation treatments could also reduce alcohol intake found no differences between the drugs, but the rate of behavioral change for alcohol consumption and smoking was high in all treatment groups. The results suggest that these drugs may play an important role in reducing alcohol consumption and smoking at the same time. Unexpectedly, nicotine replacement therapy performed as well as the prescription drugs varenicline and cytisine.

The study, published Aug. 5 in JAMA network opened, which 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 of St. Petersburg, Russia. The researchers, which included addiction specialists and HIV researchers, recruited volunteers who identified themselves as risky drinking and daily smoking. Participants were followed up to 12 months after enrollment in the clinical trial. Medications were placebo-controlled, so participants and researchers didn’t know who was assigned to which medication.

The study showed that after three months, alcohol consumption decreased regardless of whether the participants received nicotine replacement therapy, varenicline, or cytisine. The main outcome measure was number of days of heavy drinking in the past month at three months, and secondary outcomes were abstinence from alcohol at three months and abstinence from smoking at six months.

“A single drug to treat both high-risk drinking and smoking could efficiently and significantly improve health. High-risk drinking and smoking often coexist, and they both pose a health threat through the risk of cardiovascular disease, cancer and other important health outcomes,” said the study’s lead author, Hilary Tindle, MD, MPH, the William Anderson Spickard, Jr., MD, professor of medicine and associate professor of medicine at VUMC.”

Researchers are increasingly focusing on co-morbidities in people with HIV, such as cardiovascular disease and cancer, to improve their lifespan 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, principal investigator of the study, Dorothy and Laurence Grossman Chair in Cardiology and professor of medicine at VUMC. “Not only do they live with HIV, but they also have a high burden of hepatitis, multi-drug use and psychological problems. Such participants are often excluded from drug trials. If a drug as simple as nicotine replacement could help them, that would be a win.

Freiberg noted that when researchers set up the study, they envisioned the nicotine replacement as the “control” arm for alcohol consumption. Nicotine replacement therapy has been available in the United States for the treatment of tobacco addiction since the early 1980s and is not used to reduce alcohol consumption.

The study included participants who had consumed five or more heavy drinking days in the past month (defined as five or more drinks in one day for a man or four or more drinks in one day for a woman) and who had consumed five or more cigarettes per day. day smoked. day.

VUMC researchers collaborated with Jeffrey Samet, MD, MA, MPH, the John Noble, MD, professor of general internal medicine and professor of Community Health Science at Boston University Schools of Medicine and Public Health, and fellow on the study. Samet’s research focuses on substance abuse and HIV infection.

“Another important observation in our post-hoc analysis was that the percentage of alcohol consumption was lower and the percentage of alcohol abstinence higher in the people who stopped smoking compared to those who continued to smoke. These results need further investigation to understand whether the findings were directly attributable to the drugs, smoking cessation, or both,” said Samet, the study’s lead author.

Tindle added that there is much to learn about how the study drugs — called nicotinic acetylcholine receptor agonists — might work to reduce voluntary alcohol intake. Studies in animal models show that stimulation of a highly specific receptor type with the alpha-4 subunit is required. Importantly, all three study drugs target these receptors.

The researchers concluded that the results of the study, which was conducted from July 2017 to December 2020, extend previous work in several ways. Notably, this is the largest trial to study partial agonists of nicotinic acetylcholine receptors to address alcohol consumption and the first to investigate cytisine to treat both alcohol and tobacco. Cytisine has not yet been approved by the US Food and Drug Administration for the treatment of tobacco use, but it has been widely used in Eastern Europe for decades and is under active research worldwide.

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, the Providence/Boston Center for AIDS Research and the Tennessee Center for AIDS Research.

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