Clinical trial NCT01509547: Varenicline for Adolescent Smoking Cessation
Official title: A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nicotine Dependence
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 157
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment
timeFrame: 7 days at end of treatment
measure: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: 26 weeks (12 weeks of treatment plus full post-treatment follow-up)
Secondary outcomes:
measure: Percentage of Visits With Abstinence During Treatment
timeFrame: 12 weeks (all of active treatment)
measure: Percentage of Post-treatment Visits With Abstinence
timeFrame: One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits
measure: Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment
timeFrame: 12 weeks of active treatment
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kevin M Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.