Framing Messages for Smoking Cessation With Bupropion - 6

Tobacco Use Disorder Clinical Trial

Official title:

Framing Messages for Smoking Cessation With Buproprion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104598
• Other study ID #: NIDA-13334-6
• Secondary ID: P50DA013334P50-1
• Status: Completed
• Phase: N/A
• First received: March 1, 2005
• Last updated: August 7, 2013
• Start date: September 2000
• Est. completion date: December 2006

Study information

• Verified date: August 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Bupropion

Behavioral:
• Smoking Abstinence Program
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.

Locations

Country	Name	City	State
United States	Substance Abuse Treatment Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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