Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
研究概览
简要总结
Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.
详细描述
The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum of 12 years of education
- •Must report typical daily smoking of > 10 cigarettes/day over the previous year
- •Must report a history of at least 3 years of regular smoking
- •Must provide carbon monoxide measures of at least 6.5 ppm
- •Must report a willingness to quit smoking
排除标准
- •Participants engaged in behavioral and/or nicotine replacement therapies, or assisted quit efforts, within previous 6 months.
- •Must not meet criteria for other substance dependence or major psychiatric disorders.
- •Must be absent chronic medical conditions that might jeopardize health and safety, confound data interpretation or that contraindicate the administration of compounds acting at nAChR sites. This list includes disorders with direct effects on neurologic function (e.g., seizure disorders, transient ischemic events, chronic or active hepatic disease), metabolic disorders (e.g., uncontrolled Type 2 diabetes), or cardiovascular disease (e.g., hypertension, mitral valve compromise, tachycardia, or irregular heart rates).
- •Must not smoke only cigars, pipes or hookahs or use nicotine products but not cigarettes
- •Must not report current use of nicotine replacement therapies (i.e., occasions of > 4 h/week during a typical week, even if not used as a cessation aid)
- •Must not have used bupropion within the previous year
- •Must not report any past use (regardless of year) of varenicline
- •Women may not be breastfeeding, pregnant or intending to become pregnant during the study period
研究组 & 干预措施
GTS-21
Participants in the GTS-21 arm will receive 150 mg/BID GTS-21 over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
干预措施: GTS-21 (Drug)
Placebo
Participants in the Placebo arm will receive placebo compound twice daily over the course of 7 weeks. All participants will receive repeated neurobehavioral testing, laboratory assessment of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood states, and side effects.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Reported Nicotine Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8
时间窗: Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Nicotine use will be assessed using Timeline Followback procedures. Nicotine use will be reported to a trained interviewer using a Timeline Followback calendar, facilitated by calendars distributed to participants.
Change in Carbon Monoxide (CO) from baseline at weeks 5, 8
时间窗: Change in baseline at Week 5, Week 8
Expired Carbon Monoxide levels will be quantified in parts per million.
Change in Urine Cotinine (COT) from baseline at weeks 5, 8
时间窗: Change in baseline at Week 5, Week 8
Cotinine excreted in urine will be quantified in ng/mL
次要结局
- Change in Beck Depression Inventory - II (BDI-II) from baseline at weeks 5, 8(Change in baseline at Week 5, Week 8)
- Change in State Anxiety Inventory (AI) from baseline at weeks 5, 8(Change in baseline at Week 5, Week 8)
- Change in State Anger (ANG-S) from baseline at weeks 5, 8(Change in baseline at Week 5, Week 8)
- Pill Count - Week 1(Week 1)
- Pill Count - Week 5(Week 5)
- Pill Count - Week 8(Week 8)
- Change in Minnesota Withdrawal Scale from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8(Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 1(Week 1)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 2(Week 2)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 3(Week 3)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 4(Week 4)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 5(Week 5)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 6(Week 6)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 7(Week 7)
- Systematic Assessment for Treatment Emergent Events (SAFTEE) - Week 8(Week 8)
- Change in Profile of Mood States 2-A from Baseline at Week 1, 2, 3, 4, 5, 6, 7, 8(Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8)
- Rapid Visual Information Processing task (Behavior) - Baseline(Baseline)
- Rapid Visual Information Processing task - (Behavior) - Week 8(Week 8)
- Rapid Visual Information Processing task - (EEG) - Baseline(Baseline)
- Rapid Visual Information Processing task - (EEG) - Week 8(Week 8)
- Measurement of GTS-21 Concentration in Blood - Week 5(Week 5)
- Measurement of GTS-21 Concentration in Blood - Week 8(Week 8)
- Trail Making Test A (TMT-A) - Baseline(Baseline)
- Trail Making Test A (TMT-A) - Week 5(Week 5)
- Trail Making Test A (TMT-A) - Week 8(Week 8)
- Trail Making Test B (TMT-B) - Baseline(Baseline)
- Trail Making Test B (TMT-B) - Week 5(Week 5)
- Trail Making Test B (TMT-B) - Week 8(Week 8)
- N-Back Working Memory Task (Behavior) - Baseline(Baseline)
- N-Back Working Memory Task (Behavior) - Week 8(Week 8)
- N-Back Working Memory Task (EEG) - Baseline(Baseline)
- N-Back Working Memory Task (EEG) - Week 8(Week 8)
- Simple Reaction Time Test - Baseline(Baseline)
- Simple Reaction Time Test - Week 5(Week 5)
- Simple Reaction Time Test - Week 8(Week 8)
- Little Man Test - Baseline(Baseline)
- Little Man Test - Week 8(Week 8)
- Visual-Perceptual Analysis Test - Baseline(Baseline)
- Visual-Perceptual Analysis Test - Week 5(Week 5)
- Visual-Perceptual Analysis Test - Week 8(Week 8)
- Wisconsin Card Sorting Test - Baseline(Baseline)
- Wisconsin Card Sorting Test - Week 8(Week 8)
- Sternberg Short-Term Memory Test - Baseline(Baseline)
- Sternberg Short-Term Memory Test - Week 8(Week 8)
- Stroop Color Word Task - Baseline(Baseline)
- Stroop Color Word Task - Week 8(Week 8)
- Digit Symbol Substitution Task - Baseline(Baseline)
- Digit Symbol Substitution Task - Week 5(Week 5)
- Digit Symbol Substitution Task - Week 8(Week 8)
- Metabolic Panel - Baseline(Baseline)
- Metabolic Panel - Week 2(Week 2)
- Metabolic Panel - Week 5(Week 5)
- Urinalysis - Week 5(Week 5)
- Metabolic Panel - Week 8(Week 8)
- Metabolic Panel - Week 9 (Followup)(Week 9)
- Urinalysis - Baseline(Baseline)
- Urinalysis - Week 2(Week 2)
- Urinalysis - Week 8(Week 8)
- Urinalysis - Week 9 (Followup)(Week 9)
- Electrocardiogram - Baseline(Baseline)
- Electrocardiogram - Week 1(Week 1)
- Change in Reported Drug and Alcohol Use from baseline at weeks 1, 2, 3, 4, 5, 6, 7, 8(Change in baseline at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8)
- Change in Blood Pressure from baseline at weeks 2, 5, 8, 9(Change in baseline at Week 2, Week 5, Week 8, Week 9)