Randomized, Double-Blind, Placebo-Controlled Trial of SR Bupropion for Adolescent Smoking Cessation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Smoking cessation
研究概览
简要总结
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.
详细描述
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-
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adolescents (age 13-20)
- •daily smokers (over 5 cigarettes daily)
- •have motivation to quit
- •nonpsychotic
- •treated in out MHC
排除标准
- •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.
研究组 & 干预措施
Bupropion Sr
40 adolescent patients
干预措施: Bupropion (Drug)
Placebo (sugar pill)
40 adolescent patients will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Smoking cessation
时间窗: 3 months
次要结局
- Decrease in craving(3 months)