Framing Messages for Smoking Cessation With Bupropion - 6

Study Overview
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Brief Summary
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This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.

Official Title
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Framing Messages for Smoking Cessation With Buproprion

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: Bupropion
* Behavioral: Smoking Abstinence Program


Participation Criteria
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Eligibility Criteria
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Exclusion Criteria: Pregnant or nursing women, or women of child-bearing potential who are not using an adequate method of contraception Psychiatric illnesses requiring psychotropic medications (i.e., psychosis, major depression, mania), or the presence of suicidality or homocidality Current use of nicotine replacement therapies (i.e., nicotine patch, gum, or lozenges, nasal spray, or inhaler), bupropion (Zyban, Wellbutrin), or marijuana or current participation in another smoking cessation treatment Presence of unstable medical conditions (i.e., cardiac, hepatic, renal disease, diabetes mellitus) that would make a trial of bupropion SR hazardous Have taken monoamine oxidase inhibitors or metoprolol succinate within the past six weeks History of anorexia nervosa or bulimia Previous hypersensitivity to bupropion History of alcohol or other drug dependence in the past one year History of seizure disorder of any etiology (i.e., brain tumor, traumatic brain injury, substance-induced seizures, etc.) Any finding that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol visit schedule and visit requirements or put the subject at risk Sharing home or work environment with current or past participant No couples or participants who see each other every day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gain Framed Absitnence Program<br>Gain framed video and printed messages encouraging smoking abstinence with Bupropion. | Drug: Bupropion<br> <br> Behavioral: Smoking Abstinence Program<br>* This investigation was a randomized controlled study of two framed message conditions for smoking cessation in combination with open label bupropion SR (300 mg/day). Two hundred fifty-eight cigarette smokers were randomly assigned to receive either gain- or loss-framed video and printed messages encouraging smoking abstinence. Preproduced video and printed information were chosen as the intervention media because of their reliability in delivering specific framed messages. All participants were seen at a community mental health center for 6 months and received a 7-week supply of bupropion SR.<br>|
| Active Comparator: Loss Framed Abstinence Program<br>Loss framed video and printed messages encouraging smoking abstinence with Bupropion. | Drug: Bupropion<br> <br> Behavioral: Smoking Abstinence Program<br>* This investigation was a randomized controlled study of two framed message conditions for smoking cessation in combination with open label bupropion SR (300 mg/day). Two hundred fifty-eight cigarette smokers were randomly assigned to receive either gain- or loss-framed video and printed messages encouraging smoking abstinence. Preproduced video and printed information were chosen as the intervention media because of their reliability in delivering specific framed messages. All participants were seen at a community mental health center for 6 months and received a 7-week supply of bupropion SR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation at 7 days |  | 7-day point prevalence abstinence | 
| Continuous Smoking Abstinence at 6 weeks | 6-week continuous abstinence. | 6 weeks |