Status:
COMPLETED
Varenicline for Adolescent Smoking Cessation
Lead Sponsor:
Medical University of South Carolina
Conditions:
Nicotine Dependence
Eligibility:
All Genders
14-21 years
Phase:
PHASE3
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 bl...
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 literat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2018
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01509547
Start Date
August 1 2012
End Date
January 26 2018
Last Update
July 1 2020
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425