Psilocybin as a Treatment for Chronic Pain in Smokers

NCT07118332 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: Psilocybin
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

cigarettes; pain

Outcome Measures

Primary Outcomes (1)

• SAFTEE scale

  The SAFTEE will be administered before and after each session to monitor adverse events from the study medications. The SAFTEE has been used in many pharmacotherapy trials (52) and includes possible side effects of study medications.

  Day 1 and Day 7

Study Arms (1)

Psilocybin 25mg

EXPERIMENTAL

Drug: Psilocybin (drug)

Interventions

Psilocybin (drug) DRUG

25mg of Psilocybin will be given to all subject

Psilocybin 25mg

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Department of Veterans Affairs

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Psilocybin; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry • MEDPSY Psych Divisions- SATU

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)