Cholinergic Enhancement as a Treatment for Nicotine Addiction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Smoking Choice Procedure
研究概览
简要总结
You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.
详细描述
We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male smokers, aged 18 to 55 years;
- •history of smoking daily for the past 12 months, at least 10 cigarettes daily;
- •in good health as verified by medical history, screening examination, and screening laboratory tests;
- •for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.
排除标准
- •History of GAL allergy;
- •requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
- •serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;
- •abuse of alcohol or any other illicit or prescription drugs;
- •use of any other tobacco products, including smokeless tobacco and nicotine products; and
- •inability to fulfill all scheduled visits and examination procedures throughout the study period.
研究组 & 干预措施
placebo
Placebo (sugar Pill) will be given daily for 7 weeks.
干预措施: placebo (Drug)
galantamine 8mg
Galantamine extended release (8mg) will be given daily for 7 weeks.
干预措施: Galantamine 8mg (Drug)
Galantamine 16mg
Galantamine extended release (16mg) will be given daily for 5 weeks starting at week 3 after a two week titration with 8mg galantamine.
干预措施: Galantamine 16mg (Drug)
结局指标
主要结局
Smoking Choice Procedure
时间窗: Data was acquired during a single test session during week 3 of drug intervention.
After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.
次要结局
未报告次要终点