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Completed

NCT Number: NCT01509547

Varenicline for Adolescent Smoking Cessation

This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

The objective of this protocol is to examine the efficacy and safety of varenicline for smoking cessation in adolescents. The guiding design philosophy was to model the adult smoking cessation literature (allowing for indirect comparisons of efficacy in different populations) while fine-tuning some elements specifically geared for adolescents. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo. Participants will provide smoking self-report (cigarettes per day) throughout the study. Biological confirmation with carbon monoxide breathalyzer will occur at all visits, and urine cotinine measurement will occur at key time points (baseline, end of treatment and final post-treatment follow-up). Psychiatric/medical visits will occur weekly throughout active treatment to systematically monitor safety and tolerability. After the 12-week treatment course, participants will return for 3 post-treatment follow-up visits (Week 13, Week 18, and Week 26).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 14-21
  • Daily smoker for ≥6 months
  • Desire to quit smoking, with at least one prior failed quit attempt and willingness to participate in a treatment study
  • If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
  • If female, agreement to use birth control (any form of hormonal contraception such as Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine device; sterilization; or double barrier contraception, which is a combination of any two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

Exclusion criteria

  • Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
  • Lifetime history of suicidality, homicidality, or clinically significant hostility/aggression
  • Current substance dependence, other than nicotine
  • Current unstable major medical disorder
  • Current pregnancy or breastfeeding
  • Current use of medications with smoking cessation efficacy
  • Known hypersensitivity to varenicline

Treatment and study plan

Varenicline

Drug

participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Other names: Chantix

Placebo

Drug

participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

Primary outcomes

  1. Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment

    Time frame: 7 days at end of treatment

    Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit

  2. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: 26 weeks (12 weeks of treatment plus full post-treatment follow-up)

    Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.

Secondary outcomes

  1. Percentage of Visits With Abstinence During Treatment

    Time frame: 12 weeks (all of active treatment)

    Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence.

  2. Percentage of Post-treatment Visits With Abstinence

    Time frame: One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits

    Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence.

  3. Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment

    Time frame: 12 weeks of active treatment

    Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2012
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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