Framing Messages for Smoking Cessation With Bupropion - 6

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephanie O'Malley, Yale University
ClinicalTrials.gov Identifier:
NCT00104598
First received: March 1, 2005
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Tobacco Use Disorder
Drug: Bupropion
Behavioral: Smoking Abstinence Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Framing Messages for Smoking Cessation With Buproprion

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Smoking Cessation at 7 days [ Time Frame: 7-day point prevalence abstinence ] [ Designated as safety issue: No ]
  • Continuous Smoking Abstinence at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    6-week continuous abstinence.


Enrollment: 252
Study Start Date: September 2000
Study Completion Date: December 2006
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104598

Locations
United States, Connecticut
Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Stephanie O'Malley, Ph.D. Substance Abuse Treatment Unit
  More Information

Publications:
Responsible Party: Stephanie O'Malley, Director, Division of Substance Abuse Research in Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00104598     History of Changes
Other Study ID Numbers: NIDA-13334-6, P50DA013334, P50-13334-6
Study First Received: March 1, 2005
Last Updated: August 7, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014