Comparative Study of SR Bupropion for Adolescent Smoking Cessation

This study is not yet open for participant recruitment.

Verified by Geha Mental Health Center, January 2009

First Received: January 7, 2009 No Changes Posted

Sponsor:	Geha Mental Health Center
Information provided by:	Geha Mental Health Center
ClinicalTrials.gov Identifier:	NCT00819078

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled Trial of SR Bupropion for Adolescent Smoking Cessation

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth

Drug Information available for: Bupropion hydrochloride Bupropion

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
Bupropion Sr: Active Comparator 40 adolescent patients	Drug: Bupropion 300 mg/d
Placebo (sugar pill): Placebo Comparator 40 adolescent patients will receive placebo	Drug: Placebo no dosage

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
Petah Tiqva, Israel

Sponsors and Collaborators

Geha Mental Health Center

More Information

Publications:

Muramoto ML, Leischow SJ, Sherrill D, Matthews E, Strayer LJ. Randomized, double-blind, placebo-controlled trial of 2 dosages of sustained-release bupropion for adolescent smoking cessation. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1068-74.

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

Keywords provided by Geha Mental Health Center:

adolescent
bupropion
smoking
cessation
depression

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Smoking

Habits
Therapeutic Uses
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010