Recruiting
Early Phase 1

Psilocybin Therapy

Sponsor:

Yale University

Code:

NCT07118332

Conditions

Smokers With Chronic Pain

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Psilocybin (drug)

Study Details

Brief 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.

Conditions

Smokers With Chronic Pain

Study ID

NCT07118332

Start date

Jul 6, 2026

Status verified date

Jul, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Psilocybin 25mg

Interventions

Psilocybin (drug)

25mg of Psilocybin will be given to all subject

Primary outcome measure

  • SAFTEE scale [ Time Frame: Day 1 and Day 7 ]

Central Contacts and Locations

Central contacts

Mehmet Sofuoglu, M.D., Ph.D.

203-932-5711Mehmet.Sofuoglu@va.gov

Locations

Department of Veterans Affairs

Recruiting

West Haven, Connecticut, United States, 06516

Contacts

Mehmet Sofuoglu,, M.D., Ph.D.

203-932-5711 ext 12299Mehmet.sofuoglu@va.gov

More Information

Sponsor

Yale University

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • cigarettes
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-03.