View Clinical Trial (Medical Research Study)
A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
| City: |
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Charleston |
| State: |
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South Carolina |
| Zip Code: |
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29425 |
| Conditions: |
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Nicotine Dependence |
| Purpose: |
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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. All participants will concurrently
participate in a contingency management (CM) intervention, specifically designed to
reinforce participant retention.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Age 14-21
- Daily smoker for ≥6 months, smoking ≥5 cigarettes per day on average in the past
month
- 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
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| NCT ID: |
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NCT01509547 |
| Primary Contact: |
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Principal Investigator
Kevin M Gray, MD
Medical University of South Carolina
Christine Horne
Phone: 843-792-5807
Email: hornechr@musc.edu
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| Backup Contact: |
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Email: mccullos@musc.edu
Ashley McCullough
Phone: 843-792-5842
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| Location Contact: |
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Charleston, South Carolina 29425
United States
Horne
Phone: 843-792-5807
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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