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Comparative Study of SR Bupropion for Adolescent Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819078
Recruitment Status : Unknown
Verified January 2009 by Geha Mental Health Center.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2009
Last Update Posted : January 8, 2009
Information provided by:
Geha Mental Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Smoking Cessation Drug: Bupropion Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of SR Bupropion for Adolescent Smoking Cessation
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Smoking cessation [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Decrease in craving [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819078

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Contact: Gal Shoval, M.D. 972-3-9258258 ext 261

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Geha Mental Health Center Recruiting
Petah Tiqva, Israel
Contact: Gal Shoval, M.D.    972-3-9258258 ext 261   
Principal Investigator: Gal Shoval, M.D.         
Sponsors and Collaborators
Geha Mental Health Center

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Responsible Party: Dr. Gal Shoval, Geha Meantal Health Center Identifier: NCT00819078     History of Changes
Other Study ID Numbers: GehaMHC
No grants so far
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: January 8, 2009
Last Verified: January 2009
Keywords provided by Geha Mental Health Center:
Additional relevant MeSH terms:
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Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors