Comparative Study of SR Bupropion for Adolescent Smoking Cessation
Randomized, Double-Blind, Placebo-Controlled Trial of SR Bupropion for Adolescent Smoking Cessation
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 7, 2009
CompletedFirst Posted
Study publicly available on registry
January 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 8, 2009
January 1, 2009
2 years
January 7, 2009
January 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking cessation
3 months
Secondary Outcomes (1)
Decrease in craving
3 months
Study Arms (2)
Bupropion Sr
ACTIVE COMPARATOR40 adolescent patients
Placebo (sugar pill)
PLACEBO COMPARATOR40 adolescent patients will receive placebo
Interventions
Eligibility Criteria
You may qualify if:
- adolescents (age 13-20)
- daily smokers (over 5 cigarettes daily)
- have motivation to quit
- nonpsychotic
- treated in out MHC
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geha Mental Health Center
Petah Tikva, Israel
Related Publications (1)
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. doi: 10.1001/archpedi.161.11.1068.
PMID: 17984409BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 7, 2009
First Posted
January 8, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2014
Last Updated
January 8, 2009
Record last verified: 2009-01