The Development of of A Novel Therapeutic to Aid Tobacco Smoking Cessation in Persons With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Quit Status
研究概览
简要总结
The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest in quitting. The investigators predict that the novel drug will increase days of abstinence, compared with placebo, identifying potential evidence of efficacy for smoking cessation in smokers with schizophrenia.
The investigators will also assess if this new drug decreases nicotine withdrawal, craving, and cognitive impairment during early abstinence, as well as evaluate adverse effects.
详细描述
Objective:
This is a Proof of Concept study planned over nearly 2 years to determine the potential efficacy of a novel drug for smokers with schizophrenia.
This study will assess 60 smokers with a diagnosis of either schizophrenia or schizoaffective disorder with high quit interest on their ability to quit during a week-long attempt to abstain while receiving a novel drug vs. placebo, using a within-subjects cross-over design.
Research Plan:
Active drug or placebo will be provided to participants in double-blind fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •List the specific criteria for inclusion of potential subjects.
- •Men or women of any race, ages 18 to 65 years, (≥18 years, ≤ 66 years)
- •Willing to provide written informed consent
- •MINI (Sheehan et al 1998, 2008) chart and/or clinician consensus affirmed DSM IV TR or (DSM -V) diagnoses of schizophrenia or schizoaffective disorder.
- •Patients whose PANSS total scores have been stable for ≥ 4 weeks (clinician and/or subject affirmed) and at ≤ 70
- •No recent ( ≤ 3months) hospitalization, aggression, or suicidal attempts
- •Stable doses of antipsychotic medication, ≥ 4 weeks
- •Smoking Inclusion Criteria:
- •Smoke ≥ 5 cigarettes/day
- •Smoking cigarettes ≥ 1 year
排除标准
- •Smoking/Nicotine Exclusions:
- •Use of smokeless tobacco or snuff or chewing tobacco
- •Use of e-cigarettes, or any non-tobacco nicotine products (e.g. nicotine gum, lozenges, patch, etc.)
- •Current enrollment or plans to enroll in another smoking cessation program. (Bupropion use for depression will be assessed on a case by case basis)
- •Alcohol/Illicit Substance Exclusion Criteria:
- •Recent alcohol or substance dependence (≤ 3 months)
- •Current alcohol consumption that exceeds 15 standard drinks/week or greater than 2 standard drinks daily
- •Medical Exclusion Criteria:
- •Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
- •Serious or unstable medical disorder within the past 3 months (assessed by the investigators)
- •Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
- •Evidence impaired liver function test (LFT) defined as serum glutamate oxaloacetate transaminase (SGOT) (AST) or serum glutamate pyruvate transaminase (SGPT) (ALT) or alkaline phosphatase greater than 1x the upper limit of normal, or bilirubin 1x the upper limit of normal
- •Evidence of kidney failure defined as: Serum creatinine > 1.8 mg/dl for males and 1.6 mg/dl for females.
- •Any subject with a history of hematological cancers examples: leukemia, lymphoma etc. will be excluded.
- •Any clinically significant hematological laboratory abnormality (chronic low-grade laboratory values just above or below the reference range that are without clinical significance will be permitted) will be grounds for exclusion.
- •Medication Exclusion Criteria:
- •Current use or recent discontinuation (within last 14-days) of the following medications: any form of smoking cessation medication (Bupropion except when used for Depressive Disorders on a case by case basis, Varenicline, NRT); and (b) opiate-containing medications for chronic pain. Potent CYP 3A4 inhibitors will be reviewed for exclusion, see below.
- •In view of novel drug being a moderate CYP3A4 inhibitor, any subjects receiving the following narrow therapeutic index CYP3A4 substrates will be excluded: Alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine.
- •In view of the impact of clozapine on smoking cessation, patients receiving clozapine will be excluded.
- •Stable medical conditions examples: hypertension, diabetes, dyslipidemia etc that are treated and ongoing and patients are not receiving the exclusionary drugs noted above will be considered for inclusion on a case by case basis.
研究组 & 干预措施
Active JNJ Drug
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.
干预措施: Active JNJ Drug (Drug)
Active JNJ Drug
200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.
干预措施: Placebo Pill (Drug)
Placebo Pill
Placebo pill used for one week quit attempt, as part of crossover design.
干预措施: Active JNJ Drug (Drug)
Placebo Pill
Placebo pill used for one week quit attempt, as part of crossover design.
干预措施: Placebo Pill (Drug)
结局指标
主要结局
Quit Status
时间窗: Daily - Mon-Fri during the quit week in each phase
Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week) Numbers reported are collapsed across medication conditions for each medication order.
次要结局
- Withdrawal When Quit(during each quit week)
- Cognitive Functions(Assessed at the end of both treatment phases, i.e., at the end of 3 and 6 weeks.)
- Monitoring of Psychiatric Symptoms Including Psychopathology(Once at every scheduled visit)
- Number of Participants That Met Criteria for Treatment Emergent Suicidal Ideation or Behavior(Every visit up to six weeks. It is only significant when there is a positive response "Yes")
- Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results(Weeks 0, 2, 3, 5, 6)
- The Number of Participants Who Had Treatment Emergent Clinically Significant EKG Results(Baseline (Week 0) and end of study (week 6))
研究者
K.N. Roy Chengappa
Professor of Psychiatry
University of Pittsburgh