Psilocybin as a Treatment for Chronic Pain in Smokers
Recruiting now · Early Phase 1
Conditions studied: Smokers With Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT07118332
- Run by
- Yale University
- People needed
- 10
- Starts
- 2026-07-06
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- History of major medical disorders (e.g., diabetes, epilepsy, kidney or liver diseases, heart rhythm problems, heart failure, hypertension with BP greater than 140/90mmHg, history of cerebrovascular problems, severe asthma, etc.).
- lifetime history of schizophrenia, bipolar disorder, dissociative disorders, or borderline personality disorder, current major depressive episode, or PTSD.
- first- or second-degree relatives with a history of bipolar disorder or schizophrenia.
- suicide attempt or ideation in the past year.
- regular use of certain psychotropic medications (antidepressants, antipsychotics, mood stabilizers or anxiolytics) that are deemed to have the potential for adverse effects or drug reactions with psilocybin including SSRIs and MAO inhibitors.
- current untreated moderate or severe substance use disorder for any other recreational or prescription drugs other than nicotine.
- known sensitivity or intolerability to psilocybin.
Where it is running
- Department of Veterans Affairs — West Haven, Connecticut, United States (enrolling)
- Department of Veterans Affairs — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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