Phase 3
Completed N=157
Varenicline for Adolescent Smoking Cessation
Source: ClinicalTrials.gov NCT01509547 ↗Enrolled (actual)
157
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment — 4; 4 Participants
◆ Published Evidence
Highly cited
112citations · ~22 / year
Interventions for preventing weight gain after smoking cessation.
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.
Linked Publications (2)
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Interventions for preventing weight gain after smoking cessation.
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Efficacy and Safety of Varenicline for Adolescent Smoking Cessation: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment |
4; 4 | — |
| PRIMARY Number of Participants Experiencing Treatment-emergent Adverse Events |
55; 60 | — |
| SECONDARY Percentage of Visits With Abstinence During Treatment |
14.2; 7.3 | — |
| SECONDARY Percentage of Post-treatment Visits With Abstinence |
20.8; 10.6 | — |
| SECONDARY Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment |
31; 24 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01509547) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.