Tobacco Use Disorder Clinical Trial
Official title:
Framing Messages for Smoking Cessation With Buproprion
Verified date | August 2013 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.
Status | Completed |
Enrollment | 252 |
Est. completion date | December 2006 |
Est. primary completion date | September 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Substance Abuse Treatment Unit | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Toll BA, O'Malley SS, Katulak NA, Wu R, Dubin JA, Latimer A, Meandzija B, George TP, Jatlow P, Cooney JL, Salovey P. Comparing gain- and loss-framed messages for smoking cessation with sustained-release bupropion: a randomized controlled trial. Psychol Ad — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Cessation at 7 days | 7-day point prevalence abstinence | No | |
Primary | Continuous Smoking Abstinence at 6 weeks | 6-week continuous abstinence. | 6 weeks | No |
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