Episodic Future Thinking Intervention Targeting Loss Aversion and Cigarette Smoking
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 192
- 主要终点
- Loss aversion
研究概览
简要总结
Controlled laboratory experiment to examine whether Episodic Future Thinking influences loss aversion and cigarette smoking among adult individuals who currently smoke cigarettes daily.
详细描述
Specific Aim 1: Examine in a controlled laboratory study using a randomized parallel-group design whether an intervention that increases LA among 138 current adult daily cigarette smokers (≥21 years; 50% male/50% female) also (1) decreases cigarette smoking and (2) can improve with practice and (3) sustain effectiveness at a follow-up assessment. Potential influence of DD, other self-control, and potential sociodemographic confounders will be accounted for in all analyses.
Hypothesis 1.1: EFT will increase LA and reduce cigarette smoking (i.e., smoking rate). (Primary) Hypothesis 1.2: Changes in LA will mediate the effect of EFT on cigarette smoking independent of changes in DD, and relevant self-control related factors. (Primary) Hypothesis 1.3: EFT effects will be greater following Extended compared to Brief training. (Secondary) Hypothesis 1.4: Changes in LA and smoking rate sustained at follow up will be mediated by EFT habit learning indexed by the perceived automaticity of cue generation with extended EFT practice. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Inclusion criteria:
- •Adult ≥ age 21 years.
- •Able to provide informed, written consent.
- •Smoke an average of at least five (5) cigarettes per day for at least one year.
- •Breath CO levels > 8 ppm. If breath CO is less than 8 ppm, we will administer a urine test (NicAlert Strip) and include if result is greater than
- •Desire to quit smoking, but not actively trying to quit or currently taking medications to aid smoking cessation (e.g, varenicline, bupropion).
- •US citizen or a permanent resident alien with a green card
- •Comfortable reading and writing in English
- •Exclusion criteria:
- •Currently seeking treatment for smoking cessation.
- •Use of tobacco products other than traditional combusted cigarettes on more than 9 of the previous 30 days
- •Positive urine toxicological screen for illicit drug use (i.e., amphetamine, methamphetamine, cocaine, barbiturates, benzodiazepines, buprenorphine, opiates, methadone, oxycodone, phencyclidine).
- •a. A positive test for marijuana (THC) will not result in exclusion from the study.
- •d) Breath alcohol level (BAL) at <.01 (Alco-Sensor IV, Intoximeter, Inc., St Louis, MO) at intake.
- •a. Participants failing the toxicological screen will be allowed to re-screened for the study. These participants will complete the informed consent process an additional time before being re-screened.
- •e) Recent or current psychiatric episode to be determined with DSM-V criteria. f) Non-correctable vision or hearing impairments. g) Inability to independently read and comprehend written materials (consent form, other study materials and measures).
- •h) Currently pregnant (to be determined with a pregnancy test) or trying to become pregnant.
- •i) Currently breastfeeding. j) Exclusive use of "roll your own" cigarettes.
研究组 & 干预措施
Extended Episodic Future Thinking
Participants will receive Episodic Future Thinking practice for 8 sessions.
干预措施: Episodic Future Thinking (Behavioral)
Brief Episodic Future Thinking
Participants will receive Episodic Future Thinking practice for 2 sessions.
干预措施: Episodic Future Thinking (Behavioral)
Control
Participants will receive sham Episodic Recent Thinking intervention.
干预措施: Control Episodic Thinking (Behavioral)
结局指标
主要结局
Loss aversion
时间窗: 30 days
Loss aversion will be measured with a gamble task developed by Tom et al. (2007). Participants will choose whether to accept or reject each of a series of hypothetical lotteries offering a 50-50 chance of a monetary loss and a monetary gain. Participants will indicate their decision to play a lottery by clicking on accept or reject buttons (strongly accept, accept, reject, strongly reject) located on the screen below the amounts (Figure 2). The task will consist of a series of 49 trials presenting each combination of 7 possible gains (+$2, +$12, +$22, +$32, +$42, +$52, and +$62) and 7 possible losses (-$1, -$6, -$11, -$16, -$21, -$26, and -$31). Combinations of gains and losses will be presented in random order.
Cigarette self-administration
时间窗: 30 days
All participants will complete a 60-min self-administration task, in which they can earn single cigarette puffs for every 10 clicks on a moving circle on a computer screen. After completing each response requirement, participants will self-administer 1 cigarette puff. Target cigarette puff volume will be standardized at approximately 70 mL and participants will be instructed to light a cigarette without inhaling, place it in a cigarette holder connected to the pressure sensor, and inhale from the cigarette while estimated puff volume is displayed on the computer screen in real time. The displayed puff volume will turn from white to red at 60 ml and signal the approximate time participants should stop inhaling to reach 70 ml. Participants will have practiced this procedure prior to the task. Participants will be instructed that they can smoke as much or as little as they want during the task.
次要结局
- Delay discounting(30 days)
研究者
Eric A Thrailkill
Research Assistant Professor
University of Vermont