Varenicline for Adolescent Smoking Cessation

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).

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