A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Change in Opioid Craving Scale
研究概览
简要总结
Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. Investigators will compare an active and a sham treatment given twice weekly for 4-weeks. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.
详细描述
This project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison treatment. The treatment is hoped to significantly aid in the battle against the opioid epidemic that is ravaging much of the country and the world. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near infra-red mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that we determine (through a proprietary test) to have a more positive emotional valence. Based on preliminary data, we anticipate that the treatment will be very effective in reducing drug cravings, anxiety, and depression as well as in reducing relapses. Aim I will offer twice-weekly treatments to two groups, active and sham, for 4-weeks and will look specifically for differences in opioid cravings, anxiety, depression, and opioid use. The investigators will evaluate participants weekly for safety and efficacy for 3-weeks post-treatment. In Aim II a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.
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 (Participant, Outcomes Assessor)
盲法说明
The sham is created by putting a piece of aluminum foil over the light-emitting diode. It will be placed there or not placed there by a 3rd party so that neither the participant nor the outcomes assessor will know the condition of the study.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients must between the ages of 18 and 70
- •meet criterion for a history of Opioid Use Disorder (OUD) on a Diagnostic Interview.
- •have opioid cravings
- •Enrollment will be made without regard to gender or ethnicity.
- •Patients who are receiving treatment for OUD or other psychiatric disorders, either psychological or pharmacological treatments, may continue their treatment during the time of the study but will be asked to try not to alter their treatment from the onset of the experiment until its conclusion. The statistical analysis will include covariates for doses of buprenorphine and methadone and use of non-prescribed opioids
排除标准
- •past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- •history of violent behavior
- •history of a past suicide gesture or attempt, a history of current suicidal ideation, *history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), *pregnancy
- •current acute or chronic medical condition requiring a medication that has psychological side-effects.
- •impaired decision-making capacity in the judgment of the investigators.
结局指标
主要结局
Change in Opioid Craving Scale
时间窗: One year
a published 3 question scale of opioid cravings. Each question asks the patient to rate his opioid cravings at the present time from 0 (none) to 9 (extreme). We use the average of the scores of the 3 questions. A low score is best.
Change in Opioid drug use
时间窗: One year
TimeLine FollowBack method, measures the daily amount of opioid drug use (mg's of pills or grams used) for the period between observations.
次要结局
- Change in Patient reports of opioid use by TimeLine FollowBack method(One year)