NCT00104598

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

4 years

First QC Date

March 1, 2005

Last Update Submit

August 7, 2013

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Smoking Cessation at 7 days

    7-day point prevalence abstinence

  • Continuous Smoking Abstinence at 6 weeks

    6-week continuous abstinence.

    6 weeks

Study Arms (2)

Gain Framed Absitnence Program

ACTIVE COMPARATOR

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

Drug: BupropionBehavioral: Smoking Abstinence Program

Loss Framed Abstinence Program

ACTIVE COMPARATOR

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

Drug: BupropionBehavioral: Smoking Abstinence Program

Interventions

BupropionDRUG
Gain Framed Absitnence ProgramLoss Framed Abstinence Program
Smoking Abstinence ProgramBEHAVIORAL

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.

Gain Framed Absitnence ProgramLoss Framed Abstinence Program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Substance Abuse Treatment Unit

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

  • 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.

    PMID: 18072836RESULT

  • 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.

    PMID: 37230961DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Stephanie O'Malley, Ph.D.

    Substance Abuse Treatment Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Substance Abuse Research in Psychiatry

Study Record Dates

First Submitted

March 1, 2005

First Posted

March 2, 2005

Study Start

September 1, 2000

Primary Completion

September 1, 2004

Study Completion

December 1, 2006

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

US(1)