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Framing Messages for Smoking Cessation With Bupropion - 6

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Smoking Abstinence Program
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Substance Abuse Treatment Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gain Framed Absitnence Program

Loss Framed Abstinence Program

Arm Description

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

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

Outcomes

Primary Outcome Measures

Smoking Cessation at 7 days
Continuous Smoking Abstinence at 6 weeks
6-week continuous abstinence.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2005
Last Updated
August 7, 2013
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00104598
Brief Title
Framing Messages for Smoking Cessation With Bupropion - 6
Official Title
Framing Messages for Smoking Cessation With Buproprion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gain Framed Absitnence Program
Arm Type
Active Comparator
Arm Description
Gain framed video and printed messages encouraging smoking abstinence with Bupropion.
Arm Title
Loss Framed Abstinence Program
Arm Type
Active Comparator
Arm Description
Loss framed video and printed messages encouraging smoking abstinence with Bupropion.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Type
Behavioral
Intervention Name(s)
Smoking Abstinence Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Smoking Cessation at 7 days
Time Frame
7-day point prevalence abstinence
Title
Continuous Smoking Abstinence at 6 weeks
Description
6-week continuous abstinence.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie O'Malley, Ph.D.
Organizational Affiliation
Substance Abuse Treatment Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Treatment Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18072836
Citation
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.
Results Reference
result

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Framing Messages for Smoking Cessation With Bupropion - 6

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