Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Change of ExpiredCO Level From Baseline
研究概览
简要总结
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.
详细描述
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of < 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-64
- •Regular ten cigarette per day smoker for one year
- •Nicotine Dependency Score greater than or equal to four
- •DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
- •Psychiatric medication regimen unchanged for at least 90 days
- •Psychiatric medication dosage unchanged for at least 30 days
排除标准
- •Psychiatric hospitalization in last 6 months
- •Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
- •Suicide or homicide ideation with a plan in the last six months
- •Life time history of suicide attempt
- •Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
- •Current treatment with Bupropion SR
- •DSM-IV diagnosis of alcohol or substance dependence within last 6 months*
- •DSM-IV diagnosis of alcohol or substance abuse within three months *
- •Pregnancy or lactation in females (+HCG)
- •Use of tobacco product other than cigarettes
- •Use of nicotine replacements
- •Unstable or serious medical condition in last 6 months
- •Regular use of cimetidine (OTC or Rx) *Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
研究组 & 干预措施
varenicline
干预措施: varenicline (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change of ExpiredCO Level From Baseline
时间窗: Weekly for 12 weeks
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
Level of Nicotine Dependence by Treatment Assignment
时间窗: Weekly for 12 weeks
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
次要结局
- Brief Psychiatric Rating Scale (BPRS) - Psychosis Score(Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.)
- Brief Psychiatric Rating Scale (BPRS) - Total Score(Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.)
- Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score(Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.)
- Side Effects(Weekly for 12 weeks)
研究者
MPRC
Physician, Maryland Psychiatric Research Center, Outpatient Research Program
University of Maryland, Baltimore