A Comparison of Bupropion SR and Placebo for Smoking Cessation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function.
研究概览
简要总结
The purpose of this study is to examine whether the adjunctive use of bupropion SR in the context of a psychoeducational program modified for people with schizophrenia might improve the likelihood of successful abstinence in this population. If bupropion SR is effective for reducing cigarette smoking, then it will be important to determine if decreased nicotine intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In addition, it would be important to determine the effect that a reduction in nicotine stimulation would have on patient's cognitive functioning, as nicotinic receptors have been shown to regulate attention and memory function, and it is hypothesized that these functions are normalized by acute nicotine administration in people with schizophrenia
详细描述
After obtaining consent, patients will enter a two week stabilization phase followed by a 14 week treatment phase. The treatment phase begins with a 9 session group therapy led by clinic nurses trained in the educational model of the American Cancer Association. Subjects will begin the double-blind, randomized, placebo controlled medication phase of treatment following the third group session, which is two weeks prior to the established quit day. Patients will receive either bupropion SR 150mg twice a day (starting with 150mg once a day for three days) or placebo in addition to their usual medication regimen. Patients will be offered the use of nicotine replacement in the form of Nicorette gum from quit day through week 8, the end of the group therapy course. Correct use of the gum will be reviewed in group. Following completion of the group therapy course, patients will continue in their assigned medication group until study completion.
Prior to starting the study, subjects will receive a physical exam and ECG, if they have not had one in the last calendar year. All women will have a pregnancy test, and pregnant women will be excluded from the study. If not already completed, the following Index Assessments will be completed: Demographic forms 1 and 2, SCID, Schedule for the Deficit Syndrome, Patient Psychiatric and Medical History Form. The Fagerstrom Test for Nicotine Dependence, symptom/ functional ratings (BPRS, SANS), Extrapyramidal Rating Scale, body weight, and urinary cotinine levels will be obtained during stabilization and at treatment weeks 2, 4, 8, and 14. The MPRC Side-effect Check List will be obtained week 2 (the start of study medication) and biweekly thereafter throughout the end of the treatment phase. Expired carbon monoxide levels will be measured weekly during the study.
Patients will receive a 60 minute neuropsychological test battery during stabilization and at the end of the study. The test battery will consist of the Rey Auditory Verbal Learning Test, Brief Visuospatial Memory Test, Symbol Digit, Letter Number Sequencing, and Distractibility CPT. Similarly, at stabilization, treatment week 8, and study completion (treatment week 14), subjects will meet with a MIRECC rater to complete a Smoking History (on stabilization only), the Change Assessment Scale, Temptation to Smoke Scale, Decisional Balance Scale, and Smoking Abstinence Self-Efficacy Scale. At these time points they will also have antipsychotic blood levels drawn. Patients will be seen for follow-up assessments at 6 months and one-year. Urine cotinine levels, expired CO levels, and Fagerstrom Test for Nicotine Dependence will be obtained at this time.
A total of fifty subjects will be recruited from the Maryland Psychiatric Research Center, Outpatient Research Program (MPRC ORP), Key Point Southwest Mental Health Center, Revisions, Inc., and The Baltimore, VA. The sample will consist of 50 patients who meet the following inclusion and exclusion criteria:
Inclusion Criteria are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria are:
- •DSM-IV diagnosis of Schizophrenia or schizoaffective disorder
- •Regular half pack a day smokers
- •Score of at least 4 on the Nicotine Dependency Test
排除标准
- •Exclusion Criteria are:
- •Seizure disorders, other Neurologic illnesses, or a family history of seizures
- •A medical condition that could manifest psychiatrically
- •Currently experiencing a depressive episode
- •Active substance abuse
- •Currently receiving bupropion
- •Pregnant women
- •Children (<18 years of age)
- •Two consecutive sodium levels of 130 mmol/L or less
研究组 & 干预措施
Bupropion SR
干预措施: Bupropion SR (Drug)
Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function.
时间窗: Beginning and end of study
The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their
时间窗: Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8
次要结局
- To determine whether responses to the Smoking Consequences Questionnaire, Change Assessment Scale, Temptation to Smoke Scale, Decisional Balance Scale, and Smoking Abstinence Self-Efficacy Scale correlate with successful smoking cessation.(Beginning and end of study)
- BPRS, SANS, EPRS, and body weight will be used to determine the effects of bupropion SR and smoking cessation on patients' positive and negative symptoms, level of functioning, and physical health.(Baseline, week 2, 4, 8, and 14)
研究者
Robert Buchanan
Chief, Maryland Psychiatric Research Center, Outpatient Research Program
University of Maryland, Baltimore