Health TrialsbyHealthPanel

Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder

ConditionsNicotine AddictionCraving
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age22+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Persons, aged 22+

Ability to take oral medication and be willing to adhere to the dosing regimen

Disqualifiers

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)

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)

Current suicidal ideation or history of suicide attempt or self-mutilatory acts in the past 12 months

Other recreational drug use in the past 30 days (besides alcohol and cannabis) verified by oral and urine fluid toxicology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Varenicline Tartrate

    Drug

    varenicline (target dose 1mg twice daily)

  • Placebo

    Drug

    matched placebo

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: VareniclineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment

Eye gaze fixation time to active versus neutral cues from the \"NTP Cue VR Paradigm\"

Time frame
during each in-person session, at baseline and on average 8 days post baseline assessment
2

Nicotine craving

Assessed via the Tobacco Craving Questionnaire - Short-Form

Time frame
during each in-person session, at baseline and on average 8 days post baseline assessment
3

Nicotine craving

Assessed via visual analogue scales (VR paradigm and mobile surveys)

Time frame
through study completion, an average of 30 days
4

Nicotine use episodes

Assessed via the Timeline Followback

Time frame
during each in-person session, at baseline and on average 8 days post baseline assessment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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