An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 主要终点
- The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)
研究概览
简要总结
The purpose of this research study is to learn about the efficacy of a medication called varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be improved with varenicline treatment. The investigators also hypothesize that varenicline treatment will result in significant reductions in cigarette smoking. Another objective of this study is to more fully evaluate the response and tolerability to varenicline in this group of cigarette smoking adults with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients from 18-60 years of age;
- •A cigarette smoking history of at least 3 months, and currently smoking;
- •An interest in quitting smoking and a willingness to comply with all study procedures and medication instructions;
- •A current DSM-IV-TR diagnosis of ADHD confirmed by clinical psychiatric evaluation and/or ADHD module of structured diagnostic interview, completed by study clinician.
- •For females of child-bearing potential: pregnancy test at screening visit is negative and the subject does not plan to become pregnant during the study.
排除标准
- •Pregnancy or breast-feeding;
- •Clinically significant and/or unstable medical condition including renal, hepatic, or neurological, based upon a medical history and vital signs;
- •Ongoing treatment with medications which may be affected (altered blood levels) if subjects stop smoking in the study, including insulin, theophylline, and blood thinners, as determined by clinician;
- •Clinically significant cardiovascular history, including myocardial infarction, untreated hypertension, atrial fibrillation, or arrhythmia;
- •Current untreated psychiatric comorbidity which the investigator judges to be of greater than mild severity, including Major Depressive Disorder;
- •Current psychiatric comorbidity, including suicidality, homicidality, psychosis, determined by the clinician to be clinically significant and/or unstable
- •Lifetime history of DSM-IV Bipolar I disorder, Schizophrenia, or suicide attempt as determined through clinical evaluation or diagnostic interview;
- •Currently (within 3 months) meets DSM-IV criteria for abuse or dependence for any psychoactive substance other than nicotine;
- •Current treatment with mood stabilizers, anti-psychotics, nicotine replacement therapies, or varenicline;
- •Mental retardation (IQ < 75);
- •History of intolerance or allergy to varenicline.
- •Clinically significant abnormal screening values including:
- •Consistent readings of hypertension (>140/90) during screening period (including screening and baseline visits), defined as two or more readings (each being the average of three measurements) at a single visit with systolic blood pressure, SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual reading.
- •Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90 at baseline/week 0 visit, confirmed by manual reading, which are determined to be clinically significant.
研究组 & 干预措施
1
Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.
干预措施: Varenicline (Chantix) (Drug)
结局指标
主要结局
The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)
时间窗: Weekly for 7 weeks
The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54.
Time Line Follow Back of Cigarette Smoking
时间窗: Weekly for 7 weeks
The reduction in cigarette smoking, defined as the change from baseline on the amount of cigarettes per day smoked (cpd), using the time-line follow back method. This method involves asking subjects to retrospectively estimate their cigarette use 7 days to 2 years prior to the interview date.
次要结局
- Spontaneous Reports of Adverse Effects(Weekly for 7 weeks)
- Rates of Smoking Cessation(Weekly for 7 weeks)
- Exhaled CO Levels(Weekly over 7 weeks)
- ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)(Weekly for 7 weeks)
- Vital Signs(Weekly for 7 weeks)
研究者
Timothy Wilens, MD
MD
Massachusetts General Hospital