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Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

NCT04602494 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-04-04

Study results available
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Summary

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.

Conditions

  • Vaping
  • Nicotine Dependence

Interventions

DRUG

Varenicline

varenicline: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks

DRUG

Placebo

Identical placebo: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Eden Evins, MD · Massachusetts General Hospital

  • Randi Schuster, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2022-06-27
Completion
2022-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602494 on ClinicalTrials.gov