The Development and Validation of Neural Targets in Opioid Use Disorder
概览
- 阶段
- 不适用
- 干预措施
- Active repetitive Transcranial Magnetic Stimulation (rTMS)
- 疾病 / 适应症
- Opioid Use Disorder
- 发起方
- Duke University
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of participants with Relapse Free survival
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
In this research study the investigators will work with 80-participants with opioid use disorder who are starting treatment with the medication buprenorphine and are trying to quit using opioids.
The investigators are trying to learn two things:
- Can an MRI brain marker be used to predict which participants will be successful in quitting opioids with buprenorphine?
- Does adjunctive treatment with repetitive Transcranial Magnetic Stimulation (rTMS) help people quit using opioids more than a sham (placebo) version of rTMS?
In order to complete the study the investigators will ask participants to:
- Complete an MRI within 5-days of starting buprenorphine and again after they are on a full stable dose 1-3 weeks later.
- Undergo study-treatment with 30-sessions of either real or placebo rTMS in as little as 1-week (10-sessions-per-day for five days) or as long as over 6-weeks.
- Meet with the investigators once per week over the following 12-weeks to see if the participants have been able to quit using opioids over that time.
研究者
入排标准
入选标准
- •Age 18 or older; all genders included.
- •Intellectual level sufficient to provide informed consent and accurately complete assessment instruments (English speaking/writing).
- •Meet DSM-5 criteria for moderate or severe OUD. Individuals may also meet criteria for another substance use disorder (with the exception of alcohol or sedative/hypnotic); but must identify opioids as their primary substance.
- •Starting buprenorphine and planning on opioid abstinence
排除标准
- •Pregnant, breast-feeding, or planning on getting pregnant.
- •Alcohol or sedative/hypnotic use disorders (seizure risk).
- •History of/or current psychotic disorder (e.g. schizophrenia).
- •Current or lifetime bipolar disorder.
- •Unstable Axis-I condition requiring starting a new medication.
- •Active suicidal ideation / suicide attempt within 90 days.
- •History of/or current dementia or other cognitive impairment.
- •Contraindications to receiving rTMS or undergoing MRI (implanted ferromagnetic metal, history of or high risk of seizure, implanted device).
- •Unstable general medical conditions.
研究组 & 干预措施
Active rTMS
A total of 30-sessions of standard iTBS (1800 pulses) will be delivered. rTMS-sessions will be ideally administered over 1-week (10-sessions-per-day, 50-minutes inter-session-interval, 5-days), but there will be flexibility in the delivery paradigm so long as participants complete all sessions of rTMS within 6 weeks and come in at least twice per week.
干预措施: Active repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS
Double-blind sham-rTMS in an identical fashion to the active-rTMS condition will be delivered.
干预措施: Sham repetitive Transcranial Magnetic Stimulation (rTMS)
High Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define high ventral striatal reactivity as having \>mean voxels in the ventral striatum activate
干预措施: High Ventral Striatal Reactivity
Low Ventral Striatal Reactivity
We will test for ventral striatal reactivity using a Reassessment of Craving MRI task and define low ventral striatal reactivity as having \< mean voxels in the ventral striatum activate
干预措施: Low Ventral Striatal Reactivity
结局指标
主要结局
Number of participants with Relapse Free survival
时间窗: Up to 12 weeks
The number of participants who have not met relapse criteria in the 12-week follow-up phase. Relapse is defined as a) any opioid use in 4 consecutive weeks, or b) any opioid use on 7 consecutive days.
次要结局
- Weeks of opioid abstinance(12-weeks)