Psilocybin as a Treatment for Chronic Pain in Smokers
The purpose of this study is to understand whether psilocybin therapy is safe and well tolerated in improving chronic pain and increasing motivation to quit smoking for people who have chronic pain and smoke cigarettes. Psilocybin is a psychedelic drug and the active ingredient in magic mushrooms. Psilocybin is currently being studied in clinical trials but has no current medical use in the United States. Some studies have shown that a dose of psilocybin can help people quit smoking. Other studies have shown that a dose of psilocybin may improve certain chronic pain conditions, such as migraine headaches. We believe that it may also be helpful for people who smoke and have chronic pain, but this has not been tested yet.
• Veterans aged 21 to 65 years, who have been smoking tobacco cigarettes daily cigarettes for at least a year (confirmed with urine cotinine strips indicating smoking status (28)
• not seeking treatment at the time of the study for tobacco use.
• endorsement of bothersome or high-impact chronic non-cancer pain per the Graded Pain Scale - Revised (29);
• in good health as verified by medical history, screening examination, and screening laboratory tests; and
• body mass index (BMI) between 18 to 35 because there is limited information on the safety of psilocybin in individuals outside this range.
• for women, not pregnant as determined by pregnancy screening, nor breastfeeding, and using acceptable birth control methods (e.g., oral contraceptives).