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Comparative Study of SR Bupropion for Adolescent Smoking Cessation

This study is not yet open for participant recruitment.
Verified January 2009 by Geha Mental Health Center
Sponsor:
Information provided by:
Geha Mental Health Center
ClinicalTrials.gov Identifier:
NCT00819078
First received: January 7, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

Bupropion has been used successfully and safely for smoking cessation in adults. It was also used in very few studies among adolescent population. Our hypothesis is that Bupropion would be effective and safe among the adoelscent psychiatric population. A double-blind randomized controlled-trial will be held to determine that.


Condition Intervention
Smoking
Smoking Cessation
 Drug: Bupropion
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of SR Bupropion for Adolescent Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Geha Mental Health Center:

Primary Outcome Measures:
  • Smoking cessation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Decrease in craving [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupropion Sr
40 adolescent patients
 Drug: Bupropion
300 mg/d
Placebo Comparator: Placebo (sugar pill)
40 adolescent patients will receive placebo
 Drug: Placebo
no dosage
Other Name: Sugar pill serving as placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adolescents (age 13-20)
  • daily smokers (over 5 cigarettes daily)
  • have motivation to quit
  • nonpsychotic
  • treated in out MHC

Exclusion Criteria:

  • Psychiatric disorders in Axis I of DSM IV (38) (for the control group)
  • Smoking less than 6 cigarettes a day
  • Using other tobacco products other than cigarettes
  • Using any other smoking cessation treatment
  • Exhaled CO level of less than 10 ppm
  • Convulsive disorder or a history of seizures
  • A first-degree relative with a convulsive disorder
  • Past sensitivity to bupropion.
  • Positive pregnancy test
  • lactation
  • A lack of motivation to quit smoking
  • Alcohol and substance abuse (or current alcohol withdrawal)
  • Mental retardation and a lack of ability to give an informed consent
  • Concurrent use of Monoamine oxidase inhibitors (MAO-I).
  • Anorexia nervosa or bulimia nervosa.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819078

Contacts
Contact: Gal Shoval, M.D. 972-3-9258258 ext 261 shovgal@tau.ac.il

Locations
Israel
Geha Mental Health Center Recruiting
Petah Tiqva, Israel
Contact: Gal Shoval, M.D.     972-3-9258258 ext 261     shovgal@tau.ac.il    
Principal Investigator: Gal Shoval, M.D.            
Sponsors and Collaborators
Geha Mental Health Center
  More Information

Publications:

Responsible Party: Dr. Gal Shoval, Geha Meantal Health Center
ClinicalTrials.gov Identifier: NCT00819078     History of Changes
Other Study ID Numbers: GehaMHC, No grants so far
Study First Received: January 7, 2009
Last Updated: January 7, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Geha Mental Health Center:
adolescent
bupropion
smoking
cessation
depression

Additional relevant MeSH terms:
Smoking
Habits
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 May 16, 2013