Effects of Quitting Study A Test of Pre-clinical Findings
Does Smoking Cessation Increase Anhedonia? A Test of Pre-clinical Findings
研究概览
详细说明
Study design We will recruit until we have 70 current smokers who want to quit at two sites (Univ of Vermont and Dartmouth Medical School). We will also recruit a comparison group of 70 long-time former smokers to assist in interpretation of the results. In the first week, smokers will smoke their usual number of cigs/day. They will then quit and are to remain abstinent for 4 weeks. We will use a schedule of escalating monetary contingencies based on breath and saliva and/or urine samples to encourage abstinence. We will obtain dependent measures twice/week. The primary measures of reward responsivity will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task and the score on our Rewarding Events scale. Other outcomes will be delay discounting results and self-reports of anhedonia and apathy.
The study will run for 1 week pre-cessation (2 visits) and then for 4 weeks post-cessation. Measures and biochemical verifications will occur twice/wk. Former smokers will attend once a wee for four weeks.
For the first week of abstinence, the cutoff for nonsmoking will be CO <8 ppm. For the remaining weeks, abstinence will be verified with a score of 0 (<10 ng/ml of cotinine) on a test strip in a saliva or urine sample plus a CO <8 ppm.
At the initial session, completion of baseline surveys will describe the sample and also measure plausible moderators such as depression.
We believe the most direct test of reward sensitivity is an evaluation of the influence of abstinence on operant responding for a reward. Thus, we have chosen performance on the Effort Expenditure for Rewards Task (EEfRT), which examines responding as a function of response cost, reward magnitude and probability of reward, as one of our primary outcomes.
For a self-report measure we will use our Rewarding Events (RE) scale that asks both about occurrence of presumed rewarding events and their anticipated pleasantness. Our RE scale will ask participants to rate 58 items on frequency in the last week as well perceived/expected pleasantness of events.
Secondary measures include the 18-item Apathy Evaluation Scale (AES), the Temporal Experience of Pleasure (TEPS), Minnesota Nicotine Withdrawal Scale-Revised (MNWS), and a measure of delay discounting (DD).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Hampshire
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Hanover、New Hampshire、美国、03755
- Dartmouth College
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Vermont
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Burlington、Vermont、美国、05401
- University of Vermont
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
For all participants:
- 18 yrs old or older
- able to read and understand verbal English fluently
- citizen or resident alien
- agree to abstain from illegal drugs during the study
For current smokers:
- currently smoke >10 cigarettes daily for > 1 yr
- want to quit smoking for good via abrupt cessation without treatment
- willing to quit 7-14 days from study entry and not reduce before quitting
- no reduction in cigs/day by >25% in the last month
- agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
- have carbon monoxide (CO) level > or = 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
For former smokers:
- smoked >10 cigarettes daily for > 1 yr
- quit at least 1 yr ago
- use of cigarettes or e-cigarettes 5 or fewer times in past year
- no tobacco or nicotine-containing product in last month
- agree to no use of non-cigarette tobacco, non-tobacco nicotine, marijuana, illegal drugs, electronic cigarettes, or smoking cessation medications during the study
- have carbon monoxide (CO) level < 8 ppm at the time of consent
- no current use of prescribed psychoactive medications, including smoking cessation products.
Exclusion Criteria for all participants:
- History of hand or wrist problems that could be exacerbated by study participation or interferes with completion of tasks
- current (last year) mood or alcohol/drug-related psychiatric disorder or any neurological condition that could influence reward sensitivity; e.g. Parkinsonism
- used marijuana 2 or more times in the last month
- problems with the use of alcohol or illegal drugs in the last 6 months
- currently pregnant
- use of smokeless tobacco
- lacking the use of one or both hands
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Smokers Cease Smoking
Participants are paid to quit smoking without using any medications.
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Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Responses to Effort Expenditure for Rewards Task (EEfRT) Test
大体时间:four weeks after quit date
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The primary outcome will be the percent choosing the hard task and the amount of responding for a monetary reward on the EEfRT task.
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four weeks after quit date
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Rewarding Events Scale score.
大体时间:four weeks after quit date
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The score on our Rewarding Events scale.
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four weeks after quit date
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Delayed Discounting
大体时间:four weeks after quit date
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Measures preference for immediate vs. delayed rewards by responses to several scenarios.
Outcome is a statistic that describes relative preference by time to reward.
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four weeks after quit date
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Self-reports of Anhedonia and Apathy
大体时间:four weeks after quit date
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Temporal Experience of Pleasure (TEPS) and Apathy Evaluation Scale (AES) both ask participants to rate pleasantness of common rewards.
Outcome is mean rating on ordinal scales.
Positive and Negative Affect Scale (PANAS) and the Minnesota Nicotine Withdrawal Scale-Revised (MNWS) ask participants to rate several mood or nicotine withdrawal symptoms.
Outcome is mean rating on 4 or 5 point ordinal scale.
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four weeks after quit date
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Smokers cease smoking的临床试验
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St. Justine's Hospital主动,不招人
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Massachusetts General HospitalFlight Attendant Medical Research Institute完全的