Behavioral Maintenance Treatment for Smoking Cessation



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:February 2004
End Date:June 2009

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Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment
strategy in promoting longer-term smoking abstinence. The investigators will also conduct
secondary analyses of mediators and moderators of treatment response.

400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a
multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All
smokers will receive the same "Acute Phase Treatment" that combines nicotine patch,
bupropion and intensive self-regulatory skills training. Nicotine patches will be provided
for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants
will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three
individualized relapse prevention training sessions spread over a 12 week period. They will
also receive 12 weeks of self-administered RPT administered via written treatment modules.
Finally, telephone counseling will be provided in conjunction with an Interactive Voice
Response system (IVR) that will allow early detection of smoking "slips" and rapid response
by treatment staff. The other half (n=200) will be assigned to a control condition that
consists of three counselor-led sessions of "supportive therapy" spread over a 12 week
period.

Inclusion Criteria:

- Healthy adult cigarette smokers smoking at least 10 cigarettes per day

Exclusion Criteria:

- Currently pregnant

- Currently breastfeeding

- Currently diagnosed with a seizure disorder, major depression, liver disease, kidney
disease, congestive heart failure

- 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

- Previous failed quit attempt using NRT and bupropion in combination
We found this trial at
2
sites
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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San Jose, California 95131
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