A Pilot Study of Transcranial Magnetic Stimulation Plus Episodic Future Thinking for Methamphetamine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of delay discounting as assessed by the 5-Trial adjusting Delay Discounting Task
研究概览
简要总结
The purpose of this study is to assess impact of repetitive transcranial magnetic stimulation (rTMS)+Episodic Future Thinking (EFT) vs. sham rTMS+EFT on delay discounting and methamphetamine (MA) demand, on vividness of future positive events during EFT training and on frequency of episodic thinking during the week following EFT training
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for primary methamphetamine use disorder
- •Be fluent in English and able to understand the consent form
排除标准
- •Current DSM-5 diagnosis for any illicit substance use disorder other than methamphetamine and marijuana
- •Current DSM-5 diagnosis of moderate or greater severity for alcohol and marijuana use disorder
- •In the opinion of the PI, the presence of any medical, neurological, psychiatric (e.g., psychotic or bipolar disorder), or physical condition, disease, or illness that, may: (a) compromise, interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
- •Has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:
- •Structured Clinical Interview for DSM-5 (SCID-5)
- •Columbia-Suicide Severity Rating Scale (C-SSRS) Screening - Answers YES to Questions 3, 4, 5, or 6
- •Assault & homicidal danger assessment tool - Key to danger >1
- •Medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps, electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
- •History of brain surgery
- •History of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
- •Moderate-to-severe heart disease
- •History of stroke
- •Is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:
- •chlorpromazine
- •clomipramine hydrochloride
- •maprotiline hydrochloride
- •diphenhydramine
- •stimulants other than methamphetamine including the following: Dextroamphetamine and amphetamine, Dextroamphetamine, Lisdexamfetamine dimesylate, Cocaine, Methylphenidate,
- •Personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
- •Serious head injury with loss of consciousness
- •Impending incarceration
- •Pregnant or nursing females
- •Inability to read, write, or speak English
- •For adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)
研究组 & 干预措施
highfrequency rTMS+EFT
干预措施: high frequency rTMS (Device)
highfrequency rTMS+EFT
干预措施: EFT (Behavioral)
sham rTMS+EFT
干预措施: EFT (Behavioral)
sham rTMS+EFT
干预措施: sham frequency rTMS (Device)
结局指标
主要结局
Rate of delay discounting as assessed by the 5-Trial adjusting Delay Discounting Task
时间窗: before TMS+EFT, after TMS+EFT, 7-day follow-up
This 5 item questionnaire measures the extent to which participants devalue a reward as the delay to its receipt increases.This task presents choices between $500 now vs. $1,000 after a delay.The discount rate k quantifies how rapidly the value of a delayed reward decreases with time.Low k Indicates patience or low impulsivity - greater willingness to wait for larger rewards.High k Indicates impatience or high impulsivity - preference for immediate rewards over delayed ones.
Change in MA Demand as assessed by the Drug Purchasing Task
时间窗: before TMS+EFT, after TMS+EFT, 7-day follow-up
MA demand will be assessed by asking participants how many grams of MA they would purchase to use over the course of a weekend (Friday night to Sunday night) as a function of increasing price ($0 to $10000) Demand is the maximum quantity of Methamphetamine consumed if the drug was free measured in grams or dollar amount
EFT Vividness as assessed by the Vividness Scale
时间窗: measured during EFT training on study day 1
This is a single item questionnaire and is scored on a 5-point Likert scale from 1(not vivid at all) to 5( extremely vivid) for a maximum score of 5, higher score indicating more vivid outcome
EFT Engagement as assessed by the Engagement Scale
时间窗: 7-day follow-up
This is a single item questionnaire and is scored on a 4-point Likert scale 1-4 asking how often each individual engaged in EFT (i.e., every day, most days, some days, no days), higher score indicating more engagement
次要结局
- Change in prospective memory as assessed by the Prospective and Retrospective Memory Questionnaire (PRMQ)(before TMS+EFT, after TMS+EFT, 7-day follow-up)
- Change in prospective memory (PM) as assessed by the behavioral PM task(before TMS+EFT, after TMS+EFT, 7-day follow-up)
- Number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method(7-day follow-up)
- Amount of Methamphetamine used in grams as assessed by the time line follow back (TLFB) method(7-day follow-up)
研究者
Heather E. Webber, PhD
Assistant Professor
The University of Texas Health Science Center, Houston