Psilocybin as a Treatment for Chronic Pain in Smokers
Yale University
Summary
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.
Description
This will be an open-label pilot study examining the feasibility and potential efficacy of psilocybin in individuals who smoke and have chronic pain. Following the screening visit, the potential participants will have 1) an adaptation/preparation session, 2) a treatment session, and 3) two post-treatment follow-up sessions: 1 and 4 weeks after the treatment session. During study participation, participants will also complete surveys 4 times per day on a mobile device for 5 weeks (1 week before the treatment session and 4 weeks post-treatment session). General Procedures: Potential participant…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 individu…
Interventions
- DrugPsilocybin (drug)
25mg of Psilocybin will be given to all subject
Location
- Department of Veterans AffairsWest Haven, Connecticut