Psilocybin as a Treatment for Chronic Pain in Smokers

Conditions

• Smokers With Chronic Pain

Eligibility Criteria

Sex

ALL

Age

21 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Psilocybin (drug) — DRUG
  25mg of Psilocybin will be given to all subject

Study Details

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 Dates

First listed

Aug 12, 2025

Start date

Jul 6, 2026

Status verified

Jul 2026

Primary completion

Oct 1, 2027

Completion

Dec 1, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Psilocybin 25mg

Primary Outcome Measure

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

Central Contacts

• Mehmet Sofuoglu, M.D., Ph.D.
  203-932-5711
  [email protected]

Locations (2)

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