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New treatment option for Nicotine Addiction
Official title Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder
ClinicalTrials.gov ID: NCT06582888
What this study is testing
What is Varenicline Tartrate?
Varenicline Tartrate is an investigational medicine, given as an once-daily, being studied as a potential treatment for nicotine addiction.
Also referred to as Varenicline.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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
You likely can't join if
- Contraindications/conditions with special precautions for varenicline treatment (i.e., history of serious hypersensitivity or skin reactions to...
- Medical or psychiatric history affecting brain development (i.e., history and/or treatment of neurologic disorders, severe head trauma with loss of...
- 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
See the full eligibility criteria
- 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
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.