Varenicline for Adolescent Smoking Cessation

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 3

Conditions: Nicotine Dependence

Treatments: Drug: Varenicline; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01509547

Pro00014398

Details and patient eligibility

About

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.

Full 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).

Enrollment: 157 patients

Sex: All

Ages: 14 to 21 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 2 patient groups, including a placebo group

varenicline

Experimental group

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.

Treatment:

Drug: Varenicline

placebo

Placebo Comparator group

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.

Treatment:

Drug: placebo