NCT00104598 — Framing Messages for Smoking Cessation With Bupropion - 6

01

Study 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.

02

Conditions studied

Tobacco Use Disorder

Browse trials for

Tobacco Use Disorder 988

03

In context

Tobacco Use Disorder

988 studies on the registry are indexed under Tobacco Use Disorder; 125 are open to participants now.

This study's enrollment of 252 is above the median of 90 across 863 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.

Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.

Browse Yale University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility 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

05

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 252 participants (actual)

Study arms

Active comparator
Gain Framed Absitnence Program
Gain framed video and printed messages encouraging smoking abstinence with Bupropion.
Drug: Bupropion · Behavioral: Smoking Abstinence Program
Active comparator
Loss Framed Abstinence Program
Loss framed video and printed messages encouraging smoking abstinence with Bupropion.
Drug: Bupropion · Behavioral: Smoking Abstinence Program

Interventions

DrugBupropion
BehavioralSmoking 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.

06

What researchers measure

Primary outcomes

Smoking Cessation at 7 days
Time frame: 7-day point prevalence abstinence
Continuous Smoking Abstinence at 6 weeks
6-week continuous abstinence.
Time frame: 6 weeks

07

Study locations

1 site

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

08

References and documents

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. PubMed 18072836 ↗
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. PubMed 37230961 ↗

09

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID: NCT00104598
Lead sponsor: Yale University
Collaborators: National Institute on Drug Abuse (NIDA)
Responsible party: Stephanie O'Malley (Director, Division of Substance Abuse Research in Psychiatry, Yale University) — Principal investigator
First posted: Mar 2, 2005
Start date: Sep 2000
Primary completion: Sep 2004
Completion: Dec 2006
Last update: Aug 9, 2013

Study contacts

Stephanie O'Malley, Ph.D.

principal investigator · Substance Abuse Treatment Unit

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Framing Messages for Smoking Cessation With Bupropion - 6