Phase 4
N=223
Extended Treatment for Smoking Cessation
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01330043 ↗Enrolled (actual)
223
Serious AEs
1.4%
Results posted
Aug 2017
Primary outcome: Primary: Expired-air CO Verified Point-prevalence Abstinence — 44; 42 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupropion (Drug); Nicotine patch (Drug); Varenicline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expired-air CO Verified Point-prevalence Abstinence |
39; 33 | — |
| SECONDARY Expired-air CO Verified Point-prevalence Abstinence |
39; 33 | — |
Summary
Adult smokers (21-65) and adolescent smokers (18 - 21) years of age residing in Alameda and Santa Clara counties will serve as the target population for this study. A total of 400 smokers meeting eligibility criteria will be randomized. Treatment will include both open label and extended treatment phases. Randomization. Participants will be randomized to extended therapy or control conditions at baseline (prior to open label treatment) and the analysis will be intention-to-treat (ITT) to avoid the threat of selection bias. Primary hypothesis. Smokers randomized to receive CBT during extended treatment will have a higher prolonged abstinence rate (PA) at 52 week and 104 week follow-up than participants in the Supportive therapy Control treatment.
Eligibility Criteria
Inclusion Criteria
- Age at least 18 years at the beginning of the study Smoking at least 10 cigarettes a day (1/2 pack)
Exclusion Criteria
- Currently pregnant
- Currently breastfeeding
- Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure or diabetes mellitus
- History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- Family history of seizures
- Currently using intravenous drugs
- Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
- Currently using any over-the-counter stimulants and anorectics (diet pills)
- Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
- Currently on NRT or bupropion (Zyban)
- Current or past diagnosis of anorexia nervosa or bulimia nervosa
- Previous allergic response to bupropion or NRT
Data sourced from ClinicalTrials.gov (NCT01330043). 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.