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Nicotine DependencePhase 2SCANS-PSILNCT07852832

Effects of Psilocybin on Craving in Nicotine Dependence

A Phase 2 study testing Psilocybin (drug) in people with Nicotine Dependence, run by University of British Columbia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This pilot study will examine how a single 25 mg dose of psilocybin affects nicotine craving in people with nicotine dependence. Following psilocybin administration, participants will complete repeated brain imaging (MRI) sessions that mimic the design and procedures of the SCANS (H24-02776) study they previously… Read more about this study

Who is it for?
Ages 20 to 35 years
Conditions the study is for
Nicotine Dependence
What is being tested?
Psilocybin (drug)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
No sites listed yet
Study dates
Jan 2027to Jan 2028
Phase
Phase 2
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 20 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Are between 20 and 35 years old at the start of the study
  • Are enrolled in the UBC SCANS (H24-02776) study
  • Use e-cigarettes containing nicotine ≥5 (greater than or equal to) days/week for at least 1 year
  • Meet criteria for moderate nicotine dependence, as determined by the research team
  • Can verify e-cigarette use status with a saliva test
  • If they are a person able to become pregnant (PABP):
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  • Be of non-childbearing potential, defined as (i) self-reported postmenopausal status (12 months of spontaneous amenorrhea and ≥ 45 years of age); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or
  • Have a negative pregnancy test at screening and prior to each psilocybin session, and must agree to use adequate contraception through 10 days after the psilocybin session. Adequate contraception methods include intrauterine devices, oral hormones plus barrier contraception, abstinence, injectable or implanted hormonal methods, or vasectomized/non-sperm carrying sole partner. Barrier methods alone are not considered effective methods of contraception.
  • Willing to abstain from any nicotine use for ≥12 (greater than or equal to) hours and additional substance use (excluding caffeine) for ≥24 (greater than or equal to) hours before the drug and MRI sessions.
  • Can verify nicotine and additional substance use abstinence with a breathalyzer, saliva, and urine test
  • Are not actively trying to quit or cut down on your level of e-cigarette use
  • Are able to provide informed consent
  • Be able to understand, communicate and speak English

Who cannot join

  • Are left-handed or ambidextrous
  • Have any medical condition that would be contraindicated, including but not limited to:
  • seizure disorder or history of seizures;
  • a history of significantly impaired hepatic function;
  • a history of unstable or uncontrolled cardiovascular disease (coronary artery disease, heart failure, clinically significant ECG abnormality);
  • uncontrolled hypertension, resting blood pressure > 140/90 mmHg;
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  • baseline prolongation of QTc interval: >450 msec in both males and females;
  • a history of major central nervous system disease (history of cerebrovascular accident, masses, aneurysm);
  • a history of uncontrolled obstructive airway disease or significant respiratory compromise;
  • a history of uncontrolled thyroid disease;
  • a history of uncontrolled insulin dependent diabetes that may preclude safe participation in the study;
  • a history of narrow-angle glaucoma;
  • gastrointestinal conditions which may affect psilocybin absorption (i.e. stenosing peptic ulcer, pyloroduodenal obstruction);
  • a history of active obstructive urological conditions (i.e. symptomatic prostatic hypertrophy, bladder-neck obstruction) that may preclude safe participation in the study.
  • Have any reported diagnosed mental health disorder (current or in the past year) or potential mental health disorder, as determined by the MINI.
  • Have other moderate-to-severe substance use disorders (other than nicotine), as determined by the MINI.
  • Have a first- or second-degree relative with psychotic or bipolar disorder.
  • Have a personality disorder deemed to be high risk (, antisocial, borderline, narcissistic) assessed via the MINI.
  • Have a history of suicide attempt within the last 10 years or a suicidal ideation in the last year.
  • Have used classic psychedelic drugs (e.g., psilocybin, LSD, DMT, ayahuasca, or mescaline) in the last 12 months or more than 25 times in lifetime, based on self-report.
  • Are currently taking medications with known interactions with psilocybin (e.g., antidepressants, antipsychotics) or that may significantly affect research performance
  • Are pregnant, breastfeeding, or they are a PABP and not practicing an adequate form of birth control
  • Have Autism Spectrum Disorder or other cognitive impairment that would affect performance on research tasks, as determined by the research team
  • Have a non-correctable clinically significant sensory impairment (e.g., cannot hear well enough to complete an interview).
  • Are pregnant, breastfeeding, or they are a PABP and not practicing an adequate form of birth control
  • Any other finding(s) based on the screening process that the investigator determines makes the candidate unsuitable for the study
  • Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are not within normal limits
  • Have baseline heart rate outside of normal limits (e.g., >100 beats per minute).
  • Have any history of Hallucinogen Persisting Perceptive Disorder
  • Subjects currently on medications with serotonergic activity, or taking inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.
  • Have any other conditions that make MRI procedure inadvisable that may include:
  • Have implanted metal clips or wires, or other conditions including: i. Retained wires from an electronic implant that has been removed (i.e. pacemaker wires not attached to a pacemaker) ii. Cardiac pacemaker or defibrillator iii. Metal in eye or orbit iv. Ferromagnetic aneurysm clip v. Pregnancy vi. Makeup tattoos that are not designed to fade over time vii. Stainless steel intrauterine device (IUD) viii. Artificial heart valve ix. Ear or eye implant x. Brain aneurysm clip xi. Implanted electronic device (i.e. drug infusion pump, electrical stimulator) xii. Coil, catheter, or filter in any blood vessel xiii. Orthopedic hardware (artificial joint, plate, screw, rod) xiv. Shrapnel, bullets, or other metal fragments xv. Surgery, medical procedure or tattoos (including tattooed eyeliner) in the last six weeks xvi. Other metallic prostheses b. Have a personal or family history of seizures c. Have any significant neurological disorder, including any condition likely to be associated with increased intracranial pressure, space-occupying brain lesion, and cerebral aneurysm d. Claustrophobia (i.e., feel uncomfortable in small spaces), or fear of loud, repetitive sounds, or inability to lay still. Participants will have to lie still in the confined space of the MRI scanner.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Christian G Schutz contact

604-827-4287

christian.schutz@ubc.ca

About this study

Official title: Open-label, Single-arm fMRI Study Evaluating the Effects of Psilocybin on Craving in Nicotine Dependence.

This pilot study will examine how a single 25 mg dose of psilocybin affects nicotine craving in people with nicotine dependence. Following psilocybin administration, participants will complete repeated brain imaging (MRI) sessions that mimic the design and procedures of the SCANS (H24-02776) study they previously completed. This will allow us to compare craving and related brain activity before and after psilocybin. We will also explore changes in nicotine use, thoughts about nicotine, motivation to quit, and mental health symptoms. Findings will help inform the design of larger future studies of psilocybin for substance use.

Being tested
Psilocybin (drug)
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psilocybin (drug)Drug

    This is an open-label, within-subject pilot study evaluating the effects of a single 25 mg dose of psilocybin in individuals with nicotine dependence who use e-cigarettes.

Study groups in NCT07852832
Study groupRoleWhat they receive
fMRI study evaluating the effects of psilocybin on craving in nicotine dependenceExperimentalNot described
Receives: Drug: Psilocybin (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Craving (self-report)

    Questionnaire of Smoking Urges (QSU)

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

  2. Subjective Craving (Experience sampling)

    Experience-sampling craving ratings during fMRI.

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

  3. Neural correlates of craving (activation)

    Changes in brain activation associated with high versus low subjective craving (experience sampling ratings).

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

  4. Neural correlates of craving (Functional connectivity)

    Functional connectivity associated with high versus low subjective craving (experience sampling ratings).

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

Secondary outcomes (4)

  1. Nicotine use

    Timeline Follow-back

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

  2. Nicotine-related craving cognitions

    Think-aloud descriptions of nicotine craving.

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

  3. Anxiety symptoms

    State-Trait Anxiety Inventory (STAI)

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

  4. Depression symptoms

    Beck Depression Inventory (BDI)

    Measured: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852832
Sponsor's protocol ID
H26-02621
Acronym
SCANS-PSIL
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin (drug) in people with Nicotine Dependence, run by University of British Columbia.

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 13 inclusion and 32 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Christian G Schutz (604-827-4287, christian.schutz@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Craving (self-report) (time frame: Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07852832.

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 1 Oct 2026.

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