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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 7, 2009 | ||||
| Last Updated Date | January 7, 2009 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Smoking cessation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Decrease in craving [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparative Study of SR Bupropion for Adolescent Smoking Cessation | ||||
| Official Title ICMJE | Randomized, Double-Blind, Placebo-Controlled Trial of SR Bupropion for Adolescent Smoking Cessation | ||||
| 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. |
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| Detailed Description | The study will be conducted in Geha Mental Health Center. A total of 80 adolescent non-psychotic smokers will be recruited for this study. A smoker is defined as a cosumer of at least 5 cigarettes daily. A total of 80 patients will be recruited from the adolescent psychiatric wards or the adolescent clinics of the mental health center. The study group (N=40) will receive bupropion SR and the control group (N=40) will receive placebo medication. Age of participants will range from 13-20 years. Both genders will be included and all ethnic origins. All participants will receive a detailed explanation about the study, its aims, the bupropion therapy, including possible adverse effects of the drug and other possible therapeutic alternatives. They will receive a leaflet summarizing all relevant data and information. Then they and their parents will sign an informed consent to participate in the study. Procedure The mental health center's pharmacist will encapsulate the bupropion tablets, which will be supplied by the manufacturing company. The study capsules will all be kept in the hospital's pharmacy. Randomization will be performed using a random number table. The code will be held solely by the principal investigator, and will be broken in the end of the study's follow-up period, unless an emergency occurs. All participants will be given the telephone number of the principal investigator for any questions or problems arising. The subjects in both groups will be double-blindly randomized to receive either bupropion or placebo. The assignment to each group will be done randomly in order to ensure location concealment. For subjects receiving bupropion, the dose will be 150 mg/d for the first three days, increasing for 150 mg twice daily, continued for a period of eight weeks. In case of intolerable side effects, the dosage will be decreased to 150 mg daily. On recruitment, all subjects will be screened for-
Possible electrocardiographic side effects of bupropion that have been reported in the literature were tachycardia and conduction delays (widened QRS complex and/or prolonged QTc interval), but none of these delays progressed to a life-threatening arrhythmia, even in case of overdose. Exclusion criteria will be:
All subjects will be evaluated for weight, smoking, substance use, anxiety and depressive symptoms at baseline, 1 month, 3 months, 6 months and 1 year. Follow-up phase will be blinded as well. Evaluation in these time points will include:
Main outcome measures: (1) Smoking cessation for 3 months. (2) Decrease in the carving to smoke. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years to 20 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00819078 | ||||
| Responsible Party | Dr. Gal Shoval, Geha Meantal Health Center | ||||
| Study ID Numbers ICMJE | GehaMHC, No grants so far | ||||
| Study Sponsor ICMJE | Geha Mental Health Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | Geha Mental Health Center | ||||
| Verification Date | January 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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