Varenicline for Adolescent Smoking Cessation

• Status: Completed
• Trial end date: 2018-01-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Varenicline

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