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Varenicline for Adolescent Smoking Cessation

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Varenicline
placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

varenicline

placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the 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
Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.

Secondary Outcome Measures

Percentage of Visits With Abstinence During 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
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
Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment

Full Information

First Posted
December 14, 2011
Last Updated
June 29, 2020
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01509547
Brief Title
Varenicline for Adolescent Smoking Cessation
Official Title
A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
January 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment
Description
Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit
Time Frame
7 days at end of treatment
Title
Number of Participants Experiencing Treatment-emergent Adverse Events
Description
Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.
Time Frame
26 weeks (12 weeks of treatment plus full post-treatment follow-up)
Secondary Outcome Measure Information:
Title
Percentage of Visits With Abstinence During Treatment
Description
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.
Time Frame
12 weeks (all of active treatment)
Title
Percentage of Post-treatment Visits With Abstinence
Description
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.
Time Frame
One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits
Title
Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment
Description
Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment
Time Frame
12 weeks of active treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Gray, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34611902
Citation
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Results Reference
derived
PubMed Identifier
31609433
Citation
Gray KM, Baker NL, McClure EA, Tomko RL, Squeglia LM, Saladin ME, Carpenter MJ. Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial. JAMA Pediatr. 2019 Dec 1;173(12):1146-1153. doi: 10.1001/jamapediatrics.2019.3553.
Results Reference
derived

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Varenicline for Adolescent Smoking Cessation

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