---
title: Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
nct_id: NCT06582888
overall_status: RECRUITING
phase: EARLY_PHASE1
sponsor: University of California, San Diego
study_type: INTERVENTIONAL
primary_condition: Nicotine Addiction
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06582888.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06582888"
ct_last_update_post_date: 2026-03-16
last_seen_at: "2026-05-12T06:16:01.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder

**NCT ID:** [NCT06582888](https://clinicaltrials.gov/study/NCT06582888)

## Key Facts

- **Status:** RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** University of California, San Diego
- **Collaborators:** National Institute on Drug Abuse (NIDA)
- **Conditions:** Nicotine Addiction, Craving
- **Start Date:** 2024-11-19
- **Completion Date:** 2028-08-15
- **CT.gov Last Update:** 2026-03-16

## Brief 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.

## Eligibility

- **Minimum age:** 22 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

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
```

## Arms

- **Varenicline** (EXPERIMENTAL) — Following the baseline assessment, participants randomized to receive varenicline will complete an 8-day titration period to achieve the target dose. Titration of varenicline will be as follows: 0.5 mg once daily for Days 1-3, 0.5 mg twice daily for Days 4-7, and 1 mg twice daily on Day 8. Participants then return to the lab on Day 9 (or Days 10, 11 if necessary) for testing at the target dosage (1 mg twice daily) and continue at that dose for eight additional days (Days 10-17) for mobile monitoring.
- **Placebo** (PLACEBO_COMPARATOR) — Following the baseline assessment, participants randomized to receive placebo pill will follow the same dosing schedule as the active arm. They will return to the lab on Day 9 (or Days 10, 11 if necessary) for testing and continue at that dosing schedule for eight additional days (Days 10-17) for mobile monitoring.

## Interventions

- **Varenicline Tartrate** (DRUG) — varenicline (target dose 1mg twice daily)
- **Placebo** (DRUG) — matched placebo

## Primary Outcomes

- **Change in Virtual Reality Attentional Bias (VR-AB) pre- and post-treatment** _(time frame: during each in-person session, at baseline and on average 8 days post baseline assessment)_ — Eye gaze fixation time to active versus neutral cues from the \"NTP Cue VR Paradigm\"
- **Nicotine craving** _(time frame: during each in-person session, at baseline and on average 8 days post baseline assessment)_ — Assessed via the Tobacco Craving Questionnaire - Short-Form
- **Nicotine craving** _(time frame: through study completion, an average of 30 days)_ — Assessed via visual analogue scales (VR paradigm and mobile surveys)
- **Nicotine use episodes** _(time frame: during each in-person session, at baseline and on average 8 days post baseline assessment)_ — Assessed via the Timeline Followback
- **Nicotine use episodes** _(time frame: through study completion, an average of 30 days)_ — Assessed via participant fill-in on mobile surveys

## Locations (1)

- University California, San Diego, San Diego, California, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university california, san diego|san diego|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06582888.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06582888*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*