Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Opioid Craving Scale, OCS
研究概览
简要总结
The investigators wish to test the hypothesis that transcranial photobiomodulation (tPBM) (i.e., 4-minutes of 810nm near-infrared light at 250 mW/cm2 by LED to the forehead at F3 or F4 versus an indistinguishable placebo treatment) can safely reduce opioid craving in individuals with opioid dependence in a within-patient study.
详细描述
Opioid use disorders (OUD) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. The investigators have developed a novel treatment that combines transcranial photobiomodulation (t-PBM) and Schiffer's Dual Brain Psychology (DBP)
The investigators will use a randomized, double-blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three one-hour weekly sessions. After baseline measures of opioid craving, and other psychometrics, subjects will receive two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment, the investigators will use 2 tests to determine which hemisphere is more associated with a negative outlook and cravings and will treat that side before the more positive hemisphere. The primary outcome measure will be an opioid craving scale (OCS). plus weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments. Patients will be closely monitored for any possible adverse side-effects from the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
One experimenter will act as the blinder and treater. Only he will know whether the patient receives the active or sham treatment and only he will prepare and provide the treatment. The patient and outcomes assessors will be blind to the treatment.
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
- •patients complain of opioid cravings
- •between the ages of 18 and
- •meet criteria for a history of opioid dependence by DSM V.
排除标准
- •a past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- •a history of violent behavior
- •a history of a past suicide attempt
- •a history of current suicidal ideation
- •a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), pregnancy,
- •any current acute or chronic medical condition that might confound the study.
- •Any patient judged by an investigator to have an impaired decision-making capacity
结局指标
主要结局
Opioid Craving Scale, OCS
时间窗: immediately before and after treatments and one week later
A published scale that consists of 3 questions, each rated by the patient from 0 to 9. with 9 indicating severe cravings.
次要结局
- Hamilton Depression Rating Scale, HDRS(Before each treatment and 1 week later)
- Hamilton Anxiety Rating Scale, HARS(Before each treatment and 1 week later)
- The Positive and Negative Affect Scale, PANAS(Before each treatment and 1 week later)