Nicotine AddictionEarly Phase 1VRNCT06582888
Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
A Early Phase 1 study testing Varenicline Tartrate in people with Nicotine Addiction and Craving, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Nicotine Addiction, Craving
- What is being tested?
- Varenicline Tartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 15 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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
- For participants able to become pregnant: use of highly effective contraception during study enrollment
Show all 9Show fewer
- Current daily tobacco use (use on 7 days per week, on average, ≥5 cigarettes per day, in the previous 3 months)
- Tobacco use history ≥3 years
- Endorsement of past week nicotine craving
Who cannot join
- 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
- Visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness)
- Treatment seeking for tobacco use disorder/intent to quit within 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University California, San Diego
San Diego, California, 92093
Research Coordinator, 858-480-1251, vrstudy@health.ucsd.edu
Kelly Courtney, Ph.D.
About this study
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.
- Conditions
- Nicotine Addiction, Craving
- Being tested
- Varenicline Tartrate, Placebo
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline TartrateDrug
Also called Varenicline
varenicline (target dose 1mg twice daily)
PlaceboDrug
matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Varenicline Tartrate |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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\"
Measured: during each in-person session, at baseline and on average 8 days post baseline assessment
Nicotine craving
Assessed via the Tobacco Craving Questionnaire - Short-Form
Measured: during each in-person session, at baseline and on average 8 days post baseline assessment
Nicotine craving
Assessed via visual analogue scales (VR paradigm and mobile surveys)
Measured: through study completion, an average of 30 days
Nicotine use episodes
Assessed via the Timeline Followback
Measured: during each in-person session, at baseline and on average 8 days post baseline assessment
Nicotine use episodes
Assessed via participant fill-in on mobile surveys
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start19 Nov 2024
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kelly Courtney, University of California, San Diego
- Investigators
- Kelly Courtney, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582888
- Sponsor's protocol ID
- R01DA058665
- Other IDs
- R01DA058665
- Acronym
- VR
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Psychophysiology, mental health, and substance use de-identified data listed above sufficient in quality to validate and replicate the research findings described in the aims will be deposited to the National Addiction \& HIV Data Archive Program (NAHDAP) repository. For specific variables where small sample sizes may allow for easy re-identification of research participants, only summarized data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
- ClinicalTrials.gov ID
- NCT06582888
- Acronym / sponsor ID
- VR / R01DA058665
- Conditions
- Nicotine Addiction, Craving
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: Varenicline TartrateFollowing 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 | Drug: PlaceboFollowing 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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
Key exclusion criteria (6 listed)
- 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
- Visual/vestibular problems that may make task completion difficult (i.e., motion sickness, difficulty balancing, blindness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varenicline TartrateAlso: Vareniclinevarenicline (target dose 1mg twice daily) | Drug | Varenicline |
| Placebomatched placebo | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Psychophysiology, mental health, and substance use de-identified data listed above sufficient in quality to validate and replicate the research findings described in the aims will be deposited to the National Addiction \& HIV Data Archive Program (NAHDAP) repository. For specific variables where small sample sizes may allow for easy re-identification of research participants, only summarized data will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Courtney, Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Varenicline Tartrate in people with Nicotine Addiction and Craving, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (858-480-1251, vrstudy@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.