NCT05796791已完成早期 1 期
Ketamine and Motivational Enhancement Therapy for the Treatment of Tobacco Use Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Feasibility of Ketamine Treatment for Tobacco Use Disorder
研究概览
简要总结
The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for tobacco use disorder when delivered in conjunction with brief motivational enhancement therapy. Participants will receive ketamine assisted motivational enhancement therapy weekly for three weeks and there will be 2 follow up visits. All visits will also consist of questionnaires and saliva samples will be taken. The overall participation will last approximately 8 weeks.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 to 65 years old.
- •Able to provide informed consent.
- •Be a daily cigarette smoker with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking.
- •Agree to abstain from smoking for the ketamine session from 1 hour before ketamine administration
- •Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of ketamine administration. Exceptions include caffeine and nicotine.
- •Subjects taking other psychotropic medications must be maintained on a stable dose for at least four weeks before study initiation.
- •Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG) to verify normal QTc intervals.
- •Subjects with normal blood pressure not on antihypertensive medications or medication controlled hypertension as defined baseline visit systolic blood pressure (SBP) <140 mmHg or a diastolic blood pressure (DBP) <90 mmHg.
排除标准
- •Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control which can include oral, implant, intrauterine device, or patch contraceptive methods as well as barrier contraceptive methods, history of surgery such as hysterectomy or tubal ligation, or abstinence
- •Subjects who meet DSM-5 criteria for current or history of psychotic spectrum disorders or current depression or bipolar disorder based on clinical interview.
- •Subjects meeting DSM-5 criteria for current substance use disorder other than tobacco use disorder.
- •Subjects with hypertension as defined by a baseline visit systolic blood pressure (SBP) >140 mmHg or a diastolic blood pressure (DBP) >90 mmHg.
- •A history of allergic or other adverse reaction to ketamine (or its excipients).
- •Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).
- •Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease
- •Subjects who live greater than 20 miles from the study site and cannot arrange their own transportation will be excluded from the study.
- •Subjects with clinically significant kidney or liver impairment.
- •Have any current neurological illnesses including, but not limited to, seizure disorders, frequent migraines or on prophylaxis, multiple sclerosis, movement disorders, history of significant head trauma, or CNS tumor.
- •Morbidly obese (BMI >40), or severely underweight as determined by medical examination.
研究组 & 干预措施
Treatment of tobacco use disorder with ketamine
Experimental
干预措施: Ketamine Hydrochloride (Drug)
Treatment of tobacco use disorder with ketamine
Experimental
干预措施: Motivational enhancement therapy (Behavioral)
结局指标
主要结局
Feasibility of Ketamine Treatment for Tobacco Use Disorder
时间窗: 8 weeks
The primary outcome of this study will be the feasibility of using ketamine-assisted treatment for smoking cessation, which will assess the number of people selected for randomization that complete the full treatment. This will help determine if the treatment of ketamine in tobacco use would be beneficial for further study.
次要结局
- Smoking Cessation(Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8)
- Reduction in Cigarettes Smoked Per Day(Baseline, Treatment week 1, 2, 3, and follow up week 4, and 8)
研究者
研究点 (1)
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