Smokers With Chronic PainEarly Phase 1NCT07118332
Psilocybin as a Treatment for Chronic Pain in Smokers
A Early Phase 1 study testing Psilocybin (drug) in people with Smokers With Chronic Pain, run by Yale University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smokers With Chronic Pain
- What is being tested?
- Psilocybin (drug)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2026to 1 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Department of Veterans Affairs
West Haven, Connecticut, 06516
Mehmet Sofuoglu, M.D., Ph.D.
- Recruiting
Department of Veterans Affairs
West Haven, Connecticut, 06516
Mehmet Sofuoglu,, M.D., Ph.D., 203-932-5711 ext 12299, Mehmet.sofuoglu@va.gov
About this study
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.
Read the detailed description
This will be an open-label pilot study examining the feasibility and potential efficacy of psilocybin in individuals who smoke and have chronic pain. Following the screening visit, the potential participants will have 1) an adaptation/preparation session, 2) a treatment session, and 3) two post-treatment follow-up sessions: 1 and 4 weeks after the treatment session. During study participation, participants will also complete surveys 4 times per day on a mobile device for 5 weeks (1 week before the treatment session and 4 weeks post-treatment session).
General Procedures: Potential participants will undergo extensive medical and psychiatric screening to minimize the risk of study participation. Psilocybin will be administered as a 25 mg oral dose under close medical and psychiatric monitoring.
For the 24 hours before the treatment session, subjects will be asked to abstain from consuming alcoholic beverages and any illicit drugs, verified by urine drug screening and breathalyzer. Non-compliant subjects will be rescheduled or discharged from the study if they are repeatedly non-compliant. Subjects will be instructed to drink their typical number of caffeinated beverages and smoke cigarettes as usual to minimize caffeine and tobacco withdrawal, which could confound the study measures. Subjects will be instructed not to eat for 4 hours before the treatment sessions because a light snack will be provided before the beginning of the session, and lunch will be provided at the end.
- Conditions
- Smokers With Chronic Pain
- Being tested
- Psilocybin (drug)
- Keywords
- cigarettes, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
25mg of Psilocybin will be given to all subject
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin 25mg | Experimental | Not described Receives: Drug: Psilocybin (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start6 Jul 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokers With Chronic PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118332
- Sponsor's protocol ID
- Psilocybin
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin as a Treatment for Chronic Pain in Smokers
- ClinicalTrials.gov ID
- NCT07118332
- Acronym / sponsor ID
- Psilocybin
- Conditions
- Smokers With Chronic Pain
- Keywords
- cigarettes, pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be an open-label pilot study examining the feasibility and potential efficacy of psilocybin in individuals who smoke and have chronic pain. Following the screening visit, the potential participants will have 1) an adaptation/preparation session, 2) a treatment session, and 3) two post-treatment follow-up sessions: 1 and 4 weeks after the treatment session. During study participation, participants will also complete surveys 4 times per day on a mobile device for 5 weeks (1 week before the treatment session and 4 weeks post-treatment session).
General Procedures: Potential participants will undergo extensive medical and psychiatric screening to minimize the risk of study participation. Psilocybin will be administered as a 25 mg oral dose under close medical and psychiatric monitoring.
For the 24 hours before the treatment session, subjects will be asked to abstain from consuming alcoholic beverages and any illicit drugs, verified by urine drug screening and breathalyzer. Non-compliant subjects will be rescheduled or discharged from the study if they are repeatedly non-compliant. Subjects will be instructed to drink their typical number of caffeinated beverages and smoke cigarettes as usual to minimize caffeine and tobacco withdrawal, which could confound the study measures. Subjects will be instructed not to eat for 4 hours before the treatment sessions because a light snack will be provided before the beginning of the session, and lunch will be provided at the end.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psilocybin 25mg | Experimental | Drug: Psilocybin (drug) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (drug)25mg of Psilocybin will be given to all subject | Drug | Psilocybin 25mg |
Primary outcome
SAFTEE scale
Time frame: Day 1 and Day 7
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Smokers With Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin (drug) in people with Smokers With Chronic Pain, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Sofuoglu, M.D., Ph.D. (203-932-5711, Mehmet.Sofuoglu@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAFTEE scale (time frame: Day 1 and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.