Framing Messages for Smoking Cessation With Bupropion - 6

NCT ID: NCT00104598

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Gain Framed Absitnence Program

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

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Smoking Abstinence Program

Intervention Type BEHAVIORAL

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.

Loss Framed Abstinence Program

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

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

Smoking Abstinence Program

Intervention Type BEHAVIORAL

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.

Interventions

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Bupropion

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Stephanie O'Malley

Director, Division of Substance Abuse Research in Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephanie O'Malley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Substance Abuse Treatment Unit

Locations

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Substance Abuse Treatment Unit

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18072836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

Other Identifiers

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P50DA013334

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50-13334-6

Identifier Type: -

Identifier Source: secondary_id

NIDA-13334-6

Identifier Type: -

Identifier Source: org_study_id