Framing Messages for Smoking Cessation With Bupropion - 6

Framing Messages for Smoking Cessation With Buproprion

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Bupropion; Behavioral: Smoking Abstinence Program

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Substance Abuse Treatment Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gain Framed Absitnence Program; Gain framed video and printed messages encouraging smoking abstinence with Bupropion.	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.
Active Comparator: Loss Framed Abstinence Program; Loss framed video and printed messages encouraging smoking abstinence with Bupropion.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Stephanie O'Malley, Ph.D., Substance Abuse Treatment Unit

Publications and helpful links

General Publications

• 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 Addict Behav. 2007 Dec;21(4):534-44. doi: 10.1037/0893-164X.21.4.534.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: March 1, 2005
• First Submitted That Met QC Criteria: March 1, 2005
• First Posted (Estimate): March 2, 2005

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 7, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: NIDA-13334-6; P50DA013334 (U.S. NIH Grant/Contract); P50-13334-6