Psilocybin for chronic pain in people who smoke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, open-label pilot investigates the feasibility and potential effects of a 25 mg oral dose of psilocybin in veterans who smoke daily and have chronic non-cancer pain. Participants undergo preparation, a treatment session, and two follow-up visits, with daily mobile surveys for five weeks to capture experiences and outcomes. Medical and psychiatric screening are required to minimize risk, and abstinence from alcohol and illicit drugs is enforced around the treatment. The study will monitor safety and potential signals of pain relief and increased motivation to quit smoking, with data collected before, during, and after the psilocybin session.

Why it matters

Who can join: the full rules

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 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).

Exclusion Criteria:

* 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's running

• Department of Veterans Affairs
  West Haven, Connecticut, United States Recruiting
• Department of Veterans Affairs
  West Haven, Connecticut, United States Not yet recruiting

Study contacts

• Study coordinator: Mehmet Sofuoglu, M.D., Ph.D.
• Email: Mehmet.Sofuoglu@va.gov
• Phone: 203-932-5711

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.