Rochester Clinical Research takes pride in its involvement in a phase 3 smoking cessation study, which has yielded promising and effective results in participants. The study aimed to assess the efficacy of Cytisinicline, a natural alkaloid present in various plant species that mimics nicotine’s effects in the brain, in promoting nicotine abstinence. Cytisinicline aids in diminishing nicotine cravings and withdrawal symptoms, easing the process of smoking cessation for individuals.
The study duration ranged from 6 to 12 weeks, depending on the dosage administered to each participant, as well as whether they received a placebo. The study took place from October 2020 to December 2021 and consisted of 810 participants spread across 17 states in the U.S. The first group received 3 mg of Cytisinicline three times a day for 6 weeks, the second group received the same dosage for 12 weeks, and the third group received a placebo (a fake treatment with no active ingredients). The participants who received the investigational study drug exhibited a significantly higher success rate with quitting compared to those who received placebo.
The data showed that for the 6-week period, the continuous abstinence rate during weeks 3 to 6 was 25.3% with Cytisinicline versus 4.4% with placebo. During weeks 3 to 24, the rate was 8.9% with Cytisinicline and 2.6% with placebo. For the 12-week course, the continuous abstinence rate during weeks 9 to 12 was 32.6% with Cytisinicline and 7% with placebo. During weeks 9 to 24, the rate was 21.1% with Cytisinicline and 4.8% with placebo.
The cigarette epidemic remains a significant public health concern, with millions of people worldwide still addicted to smoking. In some other countries, the use of Cytisinicline to quit smoking has already been approved. Researchers are hoping that it isn’t too long before the FDA approves this medication for use in the U.S., as it provides another viable alternative for individuals, backed by successful clinical trial results.