Effects of Psilocybin on Craving in Nicotine Dependence

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-35
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Are left-handed or ambidextrous

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: fMRI study evaluating the effects of psilocybin on craving in nicotine dependenceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Subjective Craving (self-report)

Questionnaire of Smoking Urges (QSU)

Time frame
Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.
2

Subjective Craving (Experience sampling)

Experience-sampling craving ratings during fMRI.

Time frame
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).

Time frame
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).

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

Secondary outcomes

1

Nicotine use

Timeline Follow-back

Time frame
Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.
2

Nicotine-related craving cognitions

Think-aloud descriptions of nicotine craving.

Time frame
Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.
3

Anxiety symptoms

State-Trait Anxiety Inventory (STAI)

Time frame
Baseline (pre-intervention) and weekly for 6 weeks following psilocybin administration.
4

Depression symptoms

Beck Depression Inventory (BDI)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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