Varenicline for Adolescent Smoking Cessation

Nicotine Dependence Clinical Trial

Official title:

A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509547
• Other study ID #: Pro00014398
• Status: Completed
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: January 26, 2018

Study information

• Verified date: June 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days at end of treatment
Primary	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.	26 weeks (12 weeks of treatment plus full post-treatment follow-up)
Secondary	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.	12 weeks (all of active treatment)
Secondary	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.	One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits
Secondary	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	12 weeks of active treatment