Nicotine Addiction study: Varenicline Tartrate
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?
An investigational oral tablet being studied as a potential treatment for nicotine addiction. It is designed to partially activate nicotinic acetylcholine receptors in the brain, which may reduce cravings and withdrawal symptoms.
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 study aims to see whether varenicline changes how smokers react to nicotine cues and whether it affects short‑term smoking behavior.
- Who it's for
- Adults 22 years or older who smoke cigarettes every day.
- What's involved
- Participants will complete a virtual‑reality nicotine cue test, take varenicline or a placebo pill twice daily, and report their smoking via a mobile app for eight days, followed by a phone check after 30 days.
- Time commitment
- The trial lasts about six weeks, with an 8‑day medication titration period, an 8‑day follow‑up period, and a final phone visit at 30 days.
- 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
- 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
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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.