Extended Treatment for Smoking Cessation
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/5/2014 |
| Start Date: | March 2010 |
| End Date: | March 2014 |
| Contact: | Erin Crew, M.P.H. |
| Email: | eduterte@stanford.edu |
| Phone: | (408) 415-7303 |
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.
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.
During open label treatment, all receive CBT and zyban and nicotine patch. At week 10 those
who continue to smoke will be switched to varenicline through week 26. At week 10 those who
are abstinent and report low levels of craving and low levels of depression symptoms will be
withdrawn from study medications. Those who are abstinent but report difficulty with craving
or depression symptoms will remain on zyban and NRT through week 26. Medication will not be
available after week 26. All will receive CBT through week 26.
who continue to smoke will be switched to varenicline through week 26. At week 10 those who
are abstinent and report low levels of craving and low levels of depression symptoms will be
withdrawn from study medications. Those who are abstinent but report difficulty with craving
or depression symptoms will remain on zyban and NRT through week 26. Medication will not be
available after week 26. All will receive CBT through week 26.
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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