Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Nicotine Dependence
  • Vaping
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will be a randomized, placebo-controlled, parallel group, study of varenicline up to 1 mg bid for 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Eligible participants will be randomly assigned in a 1:1 ratio, in blocks of 6, to double-blind varenicline or identical placebo prepared by the MGH research pharmacy. Randomization will be computer generated by the MGH Biostatistics Center by personnel with no other interactions with study staff or participants and provided to the Research Pharmacy. The randomization code will be held in the MGH Biostatistics Center and MGH research pharmacy and available to study PI only in the case of urgent medical need. Assessments will be conducted by study staff blind to the study intervention. Treatment will be assigned according to study number, assigned sequentially to eligible participants.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 23 years
Gender
Both males and females

Description

Enrollees will include 300 nicotine dependent adolescents in Greater Boston who vape, do not smoke, and want to quit. The study will be a randomized, placebo-controlled, parallel group study of varenicline up to 1 mg bid for 12 weeks added to 12 weeks of group behavioral and texting support specific...

Enrollees will include 300 nicotine dependent adolescents in Greater Boston who vape, do not smoke, and want to quit. The study will be a randomized, placebo-controlled, parallel group study of varenicline up to 1 mg bid for 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation. The study consists of one enrollment visit, one baseline visit, twelve weekly group treatment sessions, and two bi-monthly follow up visits at 14 and 16 weeks. At the enrollment visit, participants will complete interviews, questionnaires and diagnostic assessments, as well as urine sample and vitals. At the baseline visit, participants will complete several interviews, questionnaires, provide a saliva sample for cotinine measurement, and be randomized to the varenicline treatment group or placebo treatment group. Study staff will distribute varenicline or identically appearing placebo with instructions on how to take the study medication at weeks 0, 2, 4 and 8. Participants will be instructed to all empty and unused study medication at each study visit through Week 12. At the weekly treatment meetings, participants will participate in cognitive behavioral therapy and complete questionnaires. Follow up visits will consist of interviews, questionnaires and a saliva sample.

Tracking Information

NCT #
NCT04602494
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Not Provided