Effects of Psilocybin on Craving in Nicotine Dependence

NCT07852832 | Not Yet Recruiting Phase 2

• 1 other identifier: H26-02621
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (4)

• Subjective Craving (self-report)

  Questionnaire of Smoking Urges (QSU)

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

• Subjective Craving (Experience sampling)

  Experience-sampling craving ratings during fMRI.

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

• Neural correlates of craving (activation)

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

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

• Neural correlates of craving (Functional connectivity)

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

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

Secondary Outcomes (4)

• Nicotine use

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

• Nicotine-related craving cognitions

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

• Anxiety symptoms

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

• Depression symptoms

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

Study Arms (1)

fMRI study evaluating the effects of psilocybin on craving in nicotine dependence

EXPERIMENTAL

Drug: Psilocybin (drug)

Interventions

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.

fMRI study evaluating the effects of psilocybin on craving in nicotine dependence

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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):
• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Psilocybin; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Christian G Schutz

CONTACT

604-827-4287; christian.schutz@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share