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| No grants so far |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion Sr | Active Comparator | 40 adolescent patients |
|
| Placebo (sugar pill) | Placebo Comparator | 40 adolescent patients will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion | Drug | 300 mg/d |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking cessation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in craving | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gal Shoval, M.D. | Contact | 972-3-9258258 | 261 | shovgal@tau.ac.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geha Mental Health Center | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17984409 | Background | 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. |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Drug |
no dosage |
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