Experimental Manipulation of the Emotional Salience of Cannabis Use-Related Information in Regular Cannabis Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cerebral blood flow (CBF) in the medial orbitofrontal cortex
研究概览
简要总结
The goal of this study is to test a causal neural mechanism of cannabis use-related problem recognition in individuals with severe cannabis use disorder using a non-invasive form of neuromodulation called transcranial magnetic stimulation (TMS). The main question it aims to answer is:
-Does manipulating neural activity in the medial orbitofrontal cortex of the brain affect cannabis use-related problem recognition?
Researchers will compare three forms of theta burst stimulation (TBS; sham, intermittent, and continuous) in each participant to see if manipulations in neural activity lead to changes in cannabis use-related problem recognition.
Participants will complete a screening interview about their mental health and substance use history and complete four in-person laboratory sessions, which involve questionnaires, four brief magnetic resonance imaging (MRI) scans, three TBS sessions, and three electroencephalogram (EEG) sessions. Participants will also be asked to provide urine samples and take saliva and/or breathalyzer tests at some of the lab visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for current, severe Cannabis Use Disorder (CUD), as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview
- •Reports engagement in cannabis use at least four days per week, on average, over the past year
- •Provide a urine sample positive for tetrahydrocannabinol (THC)
- •Able to read and write in English
- •Has used cannabis at least 20 days in the past month
- •Endorses at least 10 distinct (of 40 possible) cannabis use-related problems across the screening interview and Lab Visit 1 questionnaires
排除标准
- •Other non-cannabis illicit substance use more than once per month, on average, over the past year
- •Current DSM-5 moderate or severe Alcohol Use Disorder, as assessed by the Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) during the screening interview
- •History of bipolar I or psychosis spectrum disorders, as assessed by the SCID for DSM-5 during the screening interview
- •Acute suicidality requiring treatment escalation, as assessed during the screening interview
- •Currently taking any daily psychotropic medication
- •Failure to meet standard MRI inclusion criteria (i.e., no presence of claustrophobia; cardiac pacemakers; neural pacemakers; surgical clips in the brain or blood vessels; surgically implanted metal plates, screws, or pins; cochlear implants; implanted uterine devices; metal braces; other metal objects in the body; history of significant injury to the brain or spinal cord; or pregnancy)
- •Medical contraindications for transcranial magnetic stimulation (TMS; i.e., presence of a neurological disorder known to alter risk for seizures [e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches], current medication therapy known to alter seizure threshold [e.g., clomipramine, Monoamine Oxidase inhibitors, imipramine, clozapine], recurrent seizures or epilepsy or family history of hereditary epilepsy, pregnancy, metallic implants in the body or other devices that may be affected by magnetic fields, or significant heart disease or cerebrovascular disease)
- •History of allergies to cosmetics/lotions or EEG gel
- •History of migraines
- •Currently engaged in treatment for Cannabis Use Disorder
研究组 & 干预措施
Sham Theta Burst Stimulation (TBS)
干预措施: TMS - Sham (Device)
Intermittent Theta Burst Stimulation (iTBS)
干预措施: TMS - Active iTBS (Device)
Continuous Theta Burst Stimulation (cTBS)
干预措施: TMS - Active cTBS (Device)
结局指标
主要结局
Cerebral blood flow (CBF) in the medial orbitofrontal cortex
时间窗: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)
Function magnetic resonance imaging (fMRI) will be used to measure cerebral blood flow (CBF) in the medial orbitofrontal cortex (mOFC) using a 3-Tesla magnet. CBF values will be compared within-subject across stimulation conditions.
Amplitude of neurophysiological responses to self-referential cannabis use-related information
时间窗: Lab Visits 2 (day 8), 3 (day 15), and 4 (day 22)
Electroencephalogram (EEG) will be used to measure late positive potential (LPP) amplitudes to personalized auditory statements about cannabis-related positive expectancies and negative consequences, along with neutral stimuli. LPP amplitudes will be compared within-subject across stimulation conditions.
次要结局
未报告次要终点
研究者
Samantha Fede
Assistant Professor
Auburn University