Extended Treatment for Smoking Cessation

Not Recruiting

Trial ID: NCT01330043

Age - 18 Years-65 Years Gender - All Accepting Healthy Volunteers - yes

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)

Joel Killen

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

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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

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