Comparative Study of SR Bupropion for Adolescent Smoking Cessation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Geha Mental Health Center.
Recruitment status was  Not yet recruiting
Information provided by:
Geha Mental Health Center Identifier:
First received: January 7, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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 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:

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


Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
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.
  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 identifier: NCT00819078

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

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
  More Information

Responsible Party: Dr. Gal Shoval, Geha Meantal Health Center 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:

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 24, 2016