Varenicline for Adolescent Smoking Cessation
Completed · Phase 3 · Has a placebo group
Conditions studied: Nicotine Dependence
In brief
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.
Key facts
- Study ID
- NCT01509547
- Run by
- Medical University of South Carolina
- People needed
- 157
- Starts
- 2012-08-01
- Expected to finish
- 2018-01-26
- Last updated by the study team
- 2020-07-01
Who can join
Age: 14 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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