NCT01031290撤回1 期
Pilot Study Repetitive Transcranial Magnetic Stimulation (rTMS) in Cannabis Craving
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cannabis craving by Marijuana Craving Questionnaire and visual-analogue scales.
研究概览
简要总结
Background:
- Cannabis, also known as marijuana, is a commonly abused drug. There is no approved medication to treat cannabis addiction. The desire to use cannabis often increases when seeing others use it or seeing pictures of it. Researchers are interested in determining which parts of the brain are active when looking at pictures associated with cannabis.
- Repetitive transcranial magnetic stimulation (rTMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether rTMS can decrease activity in the parts of the brain that respond to cannabis, and thereby lessen cravings for cannabis.
Objectives:
- To determine whether transcranial magnetic stimulation can lower craving for cannabis when people who use cannabis are shown images that increase craving.
Eligibility:
- Individuals 18 years of age and older who are physically healthy and currently use cannabis (at least 3 times weekly for the past 2 years).
Design:
- The study will involve eight visits over 3 weeks, with each visit lasting 1 to 2 hours.
- Participants will have an initial assessment about cannabis use and provide blood and urine samples before beginning the study.
- Participants will have three magnetic resonance imaging (MRI) brain scans. The first MRI scan will look at the structure of the brain at rest. During the other two scans, participants will look at images related to and not related to cannabis use.
- The rTMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for 5 consecutive days. During these testing visits, researchers will ask questions related to drug use and craving, and collect urine and breath samples for further study.
- Participants will have two follow-up visits, 1 week and 2 weeks after the rTMS sessions, to evaluate memory and mood, and one final MRI brain scan at the end of the study.
详细描述
Primary objective:
Repetitive transcranial magnetic stimulation (rTMS) provides a non-invasive means of altering brain neural activity. This pilot study will test whether 5 days of rTMS reduces cue-induced cannabis craving and use in cannabis users.
Hypothesis:
We predict that active rTMS will significantly lower craving for cannabis compared with sham rTMS.
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •INCLUSION CRITERIA:
- •i) Eighteen to sixty-five years of age
- •ii) Cannabis user for at least 2 years, currently averaging 3 times weekly
- •iii) Reading level of at least 6th grade, based on the Wide Range Achievement Test (WRAT)
- •iv) Ability to give valid informed consent
- •v) Right-handed
- •vi) If the subject is female, of childbearing potential, and sexually active, she agrees to use a medically acceptable form of contraception, and not become pregnant for the duration of the study. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. Female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use either: (1) contraceptive pill or IUD or depot hormonal preparation (ring, injection, implant); and/or (2) a barrier method of contraception such as diaphragm, sponge with spermicide, or condom. Women who are not sexually active do not have to agree to use one of the acceptable contraception methods. Contraceptive measures will be reviewed with female subjects at each visit prior to the rTMS treatment
- •vii) Self-report experiencing cannabis craving when exposed to cannabis-associated cues
排除标准
- •i) Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness.
- •ii) Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that cannot be safely removed.
- •iii) Metal shrapnel or bullet in the head or body including metal shavings.
- •iv) Current use of any investigational drug or of any medications with anti or pro-convulsive action
- •v) Increased intracranial pressure (lowers seizure threshold)
- •vi) Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania
- •vii) History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.
- •viii) Pregnant or nursing women or women with reproductive potential not using an acceptable form of contraception.
- •ix) Any history of seizure
- •x) Current dependence (DSM-IV criteria) on substances other than cannabis or nicotine.
- •xi) Claustrophobia making them unable to tolerate lying in the MRI scanner
研究组 & 干预措施
Group A
Experimental
Active TMS
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
Group B
Sham Comparator
Sham TMS
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Cannabis craving by Marijuana Craving Questionnaire and visual-analogue scales.
时间窗: 2 weeks
次要结局
- Cannabis use by urine drug testing and self-report; Safety and tolerability, using side-effects checklist.(2 weeks)
研究者
研究点 (1)
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