Status:
COMPLETED
Varenicline for Nicotine Vaping Cessation in Adolescents
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Vaping
Nicotine Dependence
Eligibility:
All Genders
16-25 years
Phase:
PHASE4
Brief Summary
The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine ...
Detailed Description
Up to 300 adolescents, aged 16-25, who vape, do not smoke regularly, and want to quit vaping will be consented; approximately 225 eligible participants will be randomly assigned to a double blind, pla...
Eligibility Criteria
Inclusion
- Ages 16-25, inclusive;
- Self-report of daily or near daily nicotine vaping for the prior ≥ 3 months and semi-quantitative saliva screening for cotinine positive for recent nicotine use;
- Nicotine dependence as defined by a score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI), or report of persistent use despite negative consequences, or prior failed quit attempts;
- Self-report of no regular combusted tobacco use in the past 2 months at enrollment and exhaled CO \<10 ppm;
- Total body weight at enrollment ≥35 kg (77 lbs);
- Report willingness to try varenicline to stop vaping;
- Able to understand study procedures and read and write in English;
- Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
- Competent and willing to provide written informed consent (if age 18+) or assent (if under 18);
- For participants who could become pregnant: negative urine pregnancy test at enrollment and agree to use effective contraception (e.g., abstinence, hormonal contraception, intra-uterine device, sterilization, or double barrier contraception) during the study.
Exclusion
- Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
- Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
- Unstable medical condition, epilepsy, severe renal impairment;
- Inpatient psychiatric hospitalization in the prior 6 months, serious suicidal ideation or suicide attempt within 6 months of enrollment, recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
- Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion;
- 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;
- Ward of the state.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT05367492
Start Date
June 22 2022
End Date
May 28 2024
Last Update
April 27 2025
Active Locations (1)
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1
Center for Addiction Medicine
Boston, Massachusetts, United States, 02114