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Varenicline for Nicotine Addiction in Adolescents (ViVA Trial)

Phase 4

Waitlist Available

Led By Eden Evins, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Ages 16-25, inclusive;

Total body weight at enrollment ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study weeks 9, 10, 11, 12, 16, 20, 24

Awards & highlights

ViVA Trial Summary

This trial will test whether adding varenicline to group behavioral and texting support can help adolescents dependent on vaped nicotine quit smoking.

Who is the study for?

This trial is for adolescents aged 16-25 who are dependent on nicotine from vaping, willing to quit using a drug called varenicline, and can participate in group support. They must not smoke tobacco regularly or use other cessation aids. Participants under 18 need guardian consent; those who could become pregnant must agree to contraception.Check my eligibility

What is being tested?

The study tests if varenicline helps teens stop vaping when combined with behavioral support and texting compared to placebo (a dummy pill) plus the same support, or just monitoring. It's a blind test where neither participants nor researchers know who gets the real drug.See study design

What are the potential side effects?

Varenicline may cause nausea, sleep problems, mood changes, headaches, and sometimes more serious side effects like heart issues or seizures in people with certain health conditions.

ViVA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 16 and 25 years old.

Select...

I weigh at least 77 lbs and my BMI is 35 or less.

ViVA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study weeks 9, 10, 11, 12, 16, 20, 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study weeks 9, 10, 11, 12, 16, 20, 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and study weeks 9, 10, 11, 12, 16, 20, 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Continuous 4-week Nicotine Vaping Abstinence at end of treatment

Secondary outcome measures

Adverse Events

Change in General Distress

Change in Nicotine Withdrawal symptoms

+3 more

ViVA Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Double Bline VareniclineExperimental Treatment3 Interventions

Participants will... Receive the drug varenicline, in tablet form, up to 1 mg BID for 12 weeks. Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.

Group II: Single Blind Monitoring onlyActive Control1 Intervention

Participants will... Receive NO drug intervention. Attend NO behavioral support sessions. Will not be encouraged to sign up for text message vaping cessation support.

Group III: Double Blind PlaceboPlacebo Group3 Interventions

Participants will... Receive placebo tablets, identical in appearance to varenicline, up to 1 mg BID for 12 weeks. Attend QuitVaping behavioral support sessions, completed in-person or via video-conferencing, once per week for 12 weeks. Be encouraged to sign up for This Is Quitting (TIQ), a text message vaping cessation program for adolescents.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,055 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,333 Total Patients Enrolled

15 Trials studying Nicotine Addiction

2,130 Patients Enrolled for Nicotine Addiction

Eden Evins, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

5 Total Patients Enrolled

Media Library

Double Blind Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05367492 — Phase 4

Nicotine Addiction Research Study Groups: Single Blind Monitoring only, Double Blind Placebo, Double Bline Varenicline

Nicotine Addiction Clinical Trial 2023: Double Blind Placebo Highlights & Side Effects. Trial Name: NCT05367492 — Phase 4

Double Blind Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05367492 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential harmful effects could arise as a result of QuitVaping usage?

"There is ample evidence that QuitVaping has been approved as a safe treatment, so we have rated it at 3 on our scale."

Answered by AI

Are there any vacancies available for participation in this research?

"Affirmative, according to the information provided on clinicaltrials.gov's website, this medical investigation is actively recruiting subjects. Originally posted June 27th 2022 and updated most recently August 22nd of the same year, 300 participants are needed from a single location."

Answered by AI

To what extent is this clinical trial recruiting participants?

"Affirmative. Clinicaltrials.gov data indicates that recruitment for this medical study, which was initially posted on June 27th 2022 is ongoing. 300 patients are wanted from 1 centre of care."

Answered by AI

Does the research study encompass individuals aged 18 and over?

"To be eligible for this clinical trial, applicants must fall within the age range of 16 to 25 years old. For those under 18 and over 65, there are separate studies consisting of 10 participants and 80 participants respectively."

Answered by AI

How can I register for participation in this clinical trial?

"This clinical trial is accepting 300 individuals with nicotine dependence ranging in age from 16 to 25. To be eligible, candidates must fulfil the following criteria: abstaining from combustible tobacco for two months prior to enrollment; a daily or near-daily vaping habit over the course of three months before entering the study; evidence that they are nicotine dependent as indicated by an ECDI score of 4 or greater; body weight above 77 lbs and BMI no greater than 35kg/m2; willingness to try varenicline medication during the study period; comprehension and literacy in English language; parental consent (for participants under eighteen); written informed consent ("

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Varenicline for Nicotine Vaping Cessation in Adolescents

A. Eden Evins 2022. "Varenicline for Nicotine Vaping Cessation in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05367492.

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