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Varenicline for Adolescent Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01509547
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Gray, MD, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE December 14, 2011
First Posted Date  ICMJE January 13, 2012
Results First Submitted Date  ICMJE January 23, 2019
Results First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • self-report of cigarettes per day [ Time Frame: 26 weeks ]
  • change in urine cotinine measurement [ Time Frame: baseline, end of treatment (12 weeks) and final post-treatment follow-up (26 weeks) ]
  • Biological confirmation of smoking with CO breathalyzer [ Time Frame: 26 weeks ]
Change History Complete list of historical versions of study NCT01509547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
frequency of treatment-emergent adverse events [ Time Frame: 26 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Varenicline for Adolescent Smoking Cessation
Official Title  ICMJE A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Drug: Varenicline
    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 Name: Chantix
  • Drug: placebo
    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.
Study Arms  ICMJE
  • Experimental: varenicline
    Participants >55 kg will take varenicline 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily for 11 weeks. Participants ≤55 kg will take varenicline 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
    Intervention: Drug: Varenicline
  • Placebo Comparator: placebo
    Participants >55 kg will take 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 for 11 weeks. Participants ≤55 kg will take placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily for 11 weeks.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2019)
157
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2012)
166
Actual Study Completion Date  ICMJE January 26, 2018
Actual Primary Completion Date January 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01509547
Other Study ID Numbers  ICMJE Pro00014398
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevin Gray, MD, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin M Gray, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP