Psilocybin as a Treatment for Chronic Pain in Smokers

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07118332
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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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

Start date
Jul 31, 2026
Status verified
Jun 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

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Veterans AffairsWest HavenConnecticut06516
Mehmet Sofuoglu, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Department of Veterans Affairs· West Haven, CT