Framing Messages for Smoking Cessation With Bupropion - 6

Yale University

Status: Completed

Conditions: Tobacco Use Disorder

Treatments: Behavioral: Smoking Abstinence Program; Drug: Bupropion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00104598

NIDA-13334-6

P50DA013334 (U.S. NIH Grant/Contract)

P50-13334-6

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Gain Framed Absitnence Program

Active Comparator group

Description:

Gain framed video and printed messages encouraging smoking abstinence with Bupropion.

Treatment:

Behavioral: Smoking Abstinence Program

Drug: Bupropion

Loss Framed Abstinence Program

Active Comparator group

Description:

Loss framed video and printed messages encouraging smoking abstinence with Bupropion.

Treatment:

Behavioral: Smoking Abstinence Program

Drug: Bupropion