Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Vaping, Nicotine Dependence

In brief

The Investigators propose a randomized, placebo-controlled trial to test the hypothesis that varenicline added to group behavioral and texting support will be well tolerated and improve vaping cessation rates among nicotine dependent adolescents who vape, do not smoke regularly, and are willing to try treatment to stop vaping compared to placebo added to group behavioral and texting support. The study will consist of a three-arm randomized, placebo-controlled, parallel-group study of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support compared with (2) behavioral and texting support and placebo and (3) monitoring only. The primary comparison will be of vaping cessation rates in those assigned to varenicline vs placebo.To do this, the investigators propose to enroll 300 adolescents aged 16-25 who meet eligibility criteria.

Key facts

Study ID

NCT04602494

Run by

Massachusetts General Hospital

People needed

5

Starts

2020-12-18

Expected to finish

2022-06-27

Last updated by the study team

2024-04-04

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-25 inclusive;
• Self report of daily or near daily nicotine vaping for the prior ≥ 3 months, screening semi-quantitative urine cotinine positive for recent nicotine use, exhaled CO <10 ppm and score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI);
• Self-report of no combusted tobacco use in the past 2 months at enrollment;
• Total body weight at screening ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;
• Report motivation to quit vaping in the next 30 days;
• Able to understand study procedures and read and write in English;
• Competent and willing to consent to participate in study procedures.

You may not qualify if…

• Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
• Unwillingness to abstain during the study from using smoking cessation aids other than those provided by the study;
• Unstable medical condition, epilepsy, severe renal impairment;
• Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate;
• Prior adverse drug reaction to varenicline;
• Unwilling to provide urine samples;
• Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.

Where it is running

• Center for Addiction Medicine — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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