A Pilot Feasibility Study of the Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
研究概览
简要总结
This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit attempt (~4 days). The key cognitive domains include: working memory, sustained attention, and response inhibition.
详细描述
This is a single-site, phase IIa, double-blind, within-subject, cross-over, human laboratory study. Subjects will be healthy, treatment-seeking female and male adult smokers, ages 18 to 65 years old. Subjects deemed eligible for participation after an Intake Visit (~Day -7) will complete baseline assessments and receive period 1 medication (ABT-089 or placebo) at the Baseline Visit (Day 0). Subjects will take 40mg of ABT-089 or placebo, based on random assignment, every day for two identical 10-day study treatment periods.
Subjects will begin period 1 study medication on Day 1. On Days 3 and 5, subjects will complete in-clinic medication run-up and monitoring assessments. On Day 5, subjects will begin a ~24-hour period of mandatory abstinence from smoking. Day 6 is conducted in two parts. Part 1 will consist of confirmation of smoking abstinence, testing for abstinence-induced cognitive deficits and the collection of subjective assessments. Part 2 will begin with a programmed smoking lapse, after which the subjective rewarding value of the programmed lapse cigarette will be assessed. Before leaving the clinic on Day 6, subjects will receive brief cessation counseling and be instructed to try to remain abstinent from 10pm that evening until after the final Observation Visit on Day 10.
During the ~4-day monitored abstinence/observation phase, subjects will complete in-clinic observation visits (subjective assessments, medication adherence, etc.) on Days 7, 8, and 10.
After a ~3-week medication washout period and Period 2 Medication Pick-up Visit on ~Day 31, subjects will begin study medication (either ABT-089 or placebo; but will always be the opposite of the assigned study medication in period 1) and participate in period 2 of the study following the same procedures as period 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ABT-089
During both 10-day study medication periods (Days 1-10 & Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order.
Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during the 10-day medication period. During study medication period 2, these subjects will take four capsules of the matched placebo capsules.
干预措施: ABT-089 (Drug)
Placebo
These are matched placebo capsules manufactured by the study drug supplier.
During both 10-day study medication periods (Days 1-10 & Days 32-41), subjects will take 4 capsules daily. Administration of study medication will be double-blind and in counter-balanced order.
Those randomized to matched placebo during study medication period 1 will take four capsules daily during the 10-day medication period. During study medication period 2, these subjects will take four 10mg capsules (40mg daily) of the active ABT-089 capsules.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)
时间窗: Baseline (Day 0) and Test Day (Days 6 & 37)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)
时间窗: Baseline (Day 0) and Test Day (Days 6 & 37)
We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence. To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 \& 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo. Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds). All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic. NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)
次要结局
- Effects of ABT-089 on Smoking Urges/Craving(Days 6 and 37)
- Effects of ABT-089 on Mood(Days 6 and 37)
- Effects of ABT-089 on Withdrawal Symptoms(Days 6 and 37)
- Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms(Days 6 and 37)
- Effects of ABT-089 on Cigarette Ratings(Days 6 and 37)
- Effects of ABT-089 on Days of Biochemically-confirmed Abstinence(Days 7, 8, 9, 10, 38, 39, 40, & 41)