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Nicotinic Acetylcholine Receptor Partial Agonist

Varenicline for Nicotine Addiction (VR Trial)

Phase < 1

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

3. Persons, aged 22+

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 30 days

Summary

This trial will enroll 200 daily tobacco cigarette users from San Diego, aged 22 and older. Participants will undergo assessments using a virtual reality nicotine cue exposure test. They will then be randomly assigned to

Who is the study for?

This trial is for daily tobacco users aged 22 or older who smoke at least 5 cigarettes a day and have been doing so for over 3 years. Participants must be willing to follow the study procedures, take oral medication, and if they can become pregnant, use effective contraception.

What is being tested?

The study tests whether Varenicline Tartrate helps reduce cravings in tobacco users compared to a placebo. It involves VR assessments of nicotine cues before and after taking the drug or placebo, followed by mobile check-ins and a final phone assessment after one month.

What are the potential side effects?

Varenicline may cause nausea, sleep disturbances (like insomnia or vivid dreams), constipation, gas, vomiting. Some people might also experience changes in taste or dry mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

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I can take pills and will follow the medication schedule.

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I have used tobacco for 3 or more years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Nicotine craving

Nicotine use episodes

Side effects data

From 2013 Phase 4 trial • 1510 Patients • NCT01370356

28%

Nausea

13%

Nasopharyngitis

11%

Abnormal dreams

11%

Insomnia

Upper respiratory tract infection

Headache

Anxiety

Fatigue

Constipation

Irritability

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Varenicline

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VareniclineExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline Tartrate

2008

Completed Phase 4

~2880

0 / 3Eligibility criteria met