Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by Kelly Courtney
Headshot of Kelly Courtney
Kelly Courtney

Description

Summary

The proposed project will include enrollment of 200 daily tobacco cigarette users, ages 22+, from the San Diego community. Participants will be assessed on the VR Nicotine Cue Exposure paradigm then randomized (stratified on age and sex) to receive varenicline (target dose 1mg twice daily) or placebo (n per group=100; total N=200). Following eight days of titration, participants will be assessed again on the VR Nicotine Cue Exposure paradigm. They will then be followed via mobile assessments for eight days on target dose of varenicline, and 30-days post assessment by phone, to assess short-term nicotine use behaviors.

Keywords

Nicotine Addiction, Craving, Tobacco Use Disorder, Varenicline, Varenicline Tartrate

Eligibility

You can join if…

Open to people ages 22 years and up

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Persons, aged 22+
  4. Ability to take oral medication and be willing to adhere to the dosing regimen
  5. For participants able to become pregnant: use of highly effective contraception during study enrollment
  6. Current daily tobacco use (use on 7 days per week, on average, ≥5 cigarettes per day, in the previous 3 months)
  7. Tobacco use history ≥3 years
  8. Endorsement of past week nicotine craving

You CAN'T join if...

  1. Contraindications/conditions with special precautions for varenicline treatment (i.e., history of serious hypersensitivity or skin reactions to varenicline, history of severe renal impairment, seizures, severe cardiovascular disease, chronic or severe nausea, Stevens-Johnson syndrome, erythema multiforme, pregnancy or nursing)
  2. Medical or psychiatric history affecting brain development (i.e., history and/or treatment of neurologic disorders, severe head trauma with loss of consciousness >2 minutes, or current severe Diagnostic and Statistical Manual 5th edition (DSM-5) psychiatric disorders other than tobacco use disorders)
  3. Current suicidal ideation or history of suicide attempt or self-mutilatory acts in the past 12 months
  4. Other recreational drug use in the past 30 days (besides alcohol and cannabis) verified by oral and urine fluid toxicology
  5. Visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness)
  6. Treatment seeking for tobacco use disorder/intent to quit within 30 days

Location

  • University California, San Diego
    San Diego California 92093 United States

Lead Scientist at UCSD

  • Kelly Courtney
    My program of research is centered on discovering the neurobiological and psychophysiological mechanisms that underlie the development and maintenance of alcohol and other substance addiction in order to inform intervention efforts. I am particularly interested in the concept of substance craving as it represents an important phenotype of addiction with great potential for intervention.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06582888
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated