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Extended Treatment for Smoking Cessation
Not Recruiting
Trial ID: NCT01330043
Purpose
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.
Official Title
Extended Treatment for Smoking Cessation
Stanford Investigator(s)
Eligibility
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:
1. Currently pregnant
2. Currently breastfeeding
3. Currently diagnosed with a seizure disorder, major depression, liver disease, kidney
disease, congestive heart failure or diabetes mellitus
4. History of a seizure, seizure disorder, significant head trauma or central nervous
system tumor
5. Family history of seizures
6. Currently using intravenous drugs
7. Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on
a daily basis
8. Currently using any over-the-counter stimulants and anorectics (diet pills)
9. Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine
oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids
or levodopa
10. Currently on NRT or bupropion (Zyban)
11. Current or past diagnosis of anorexia nervosa or bulimia nervosa
12. Previous allergic response to bupropion or NRT
Intervention(s):
drug: Bupropion
drug: Nicotine patch
drug: Varenicline
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Erin Crew, M.P.H.
(408) 415-7301