Phase 4
N=312
Smoking Cessation Study In Healthy Adolescent Smokers
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01312909 ↗Enrolled (actual)
312
Serious AEs
1.6%
Results posted
Jun 2018
Primary outcome: Primary: 4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12 — 20.2; 27.2; 18.0 percentage of participants — p=0.6337
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline 1mg BID (Drug); Varenicline 0.5mg BID (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12 |
20.2; 27.2; 18.0 | 0.6337 |
| SECONDARY Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52 |
31.2; 37.9; 23.0; 31.2; 35.9; 23.0 | 0.5793 |
| SECONDARY Daily Number of Cigarettes Smoked at Baseline |
10.68; 9.56; 9.57 | — |
| SECONDARY Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52 |
-8.56; -8.20; -8.01; -6.93; -7.31; -6.59 | 0.3540 |
| SECONDARY Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52 |
10.1; 24.3; 13.0; 8.3; 20.4; 9.0 | 0.6133 |
Summary
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Eligibility Criteria
Inclusion Criteria
- Healthy male and female subjects between the ages of 12 and 19, inclusive.
- Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,
- Subjects must have at least one prior failed attempt to quit smoking.
Exclusion Criteria
- Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).
- Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.
- Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT01312909). 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.