Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Feasibility--adherence to intervention
研究概览
简要总结
Investigators propose to conduct a pilot double-blind, parallel arm, randomized placebo-controlled trial evaluating the feasibility, acceptability, and preliminary efficacy of bright light therapy on reward system functioning among patients undergoing medication-assisted treatment for opioid use disorder.
详细描述
Bright light therapy (BLT) is a simple, safe, and accessible intervention that can effectively ameliorates sleep disruptions, as well as circadian misalignment and depressive symptoms, and could potentially improve reward system function among patients with OUD. Beyond seasonal affective disorder, BLT has shown efficacy as an intervention for non-seasonal depression, and post-traumatic stress disorder, which all exhibit significant impairment of the dopaminergic reward system and poor sleep quality as key symptoms. Investigators propose to conduct a pilot double-blind, parallel arm, randomized placebo-controlled trial evaluating the feasibility, acceptability, and preliminary efficacy of BLT on reward system functioning among patients undergoing medication-assisted treatment for OUD. The present study will establish feasibility for a larger randomized-clinical trial proposal.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •age between 18 and 65
- •ability to speak, write, and read in English
- •past 2 weeks of insomnia as evidenced by Insomnia Severity Index (ISI) total score of ≥10
- •enrolled in outpatient medication-assisted treatment for OUD (i.e., either methadone or buprenorphine treatment)
- •been in medication-assisted treatment for at least 3 months
- •at least one month of stable methadone or buprenorphine dose
- •have a smartphone
排除标准
- •lifetime history of bipolar disorder or mania
- •current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history
- •history of seizure disorders/epilepsy
- •the STOP-Bang score for obstructive sleep apnea ≥ 5
- •retinal pathology, history of eye surgery or taking photosensitizing medications (e.g., lithium, L-tryptophan)
- •current regular use of melatonin
- •have circumstances that would interfere with study participation (e.g., impending jail sentence)
- •previous experience with bright light therapy
- •working a night shift or traveling outside the Arizona time zone in the past month
- •pregnant, trying to get pregnant, or breastfeeding
- •currently wearing prescription glasses with blue-light protection
研究组 & 干预措施
Bright light therapy group
Participants will receive 30-minute morning bright light therapy for 2 weeks. Participants will start the therapy within a few minutes of their designated wake up time, which is determined by their average wake time from the baseline week of sleep assessment.
干预措施: Wearable bright light therapy device (Device)
Dim light (placebo) group
Participants will receive 30-minute dim light (placebo) therapy for 2 weeks. Participants will start the therapy within a few minutes of their designated wake up time, which is determined by their average wake time from the baseline week of sleep assessment.
干预措施: Wearable placebo light therapy device (Device)
结局指标
主要结局
Feasibility--adherence to intervention
时间窗: At 2 weeks post-treatment
The number of days bright light therapy was completed divided by the total number of treatment days
Acceptability of the intervention
时间窗: At 2 weeks post-treatment
It will be measured by the Global Satisfaction subscale in an adapted version of the Treatment Satisfaction Questionnaire for Medication. The scores are calculated for each of the subscales, which range from 0 to 100, with higher scores indicating higher patient satisfaction with the intervention.
Changes in reward valuation
时间窗: Baseline and 2 weeks post-treatment
Delayed Discounting Task will be used to assess reward valuation
Feasibility--drop-out rate
时间窗: At 2 weeks post-treatment
From enrollment to post-treatment assessment
Changes in reward learning
时间窗: Baseline and 2 weeks post-treatment
Probabilistic Reward Task will be used to assess reward learning
Changes in Opioid Craving
时间窗: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
To assess daily opioid craving, participants will be asked to rate the degree to which they have an urge to use illicit opioids in the moment on a 0-100 Visual Analogue Scale, with 0 being "Not at All" and 100 being "Extremely." This will be assessed multiple times per day via ecological momentary assessments. The timing of administration will be pseudo-randomized, but will broadly cover morning, midday and evening. Higher scores indicate greater opioid craving.
次要结局
- Wake After Sleep Onset (WASO)(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
- Positive Affect(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
- Illicit Opioid Use Frequency(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
- Total Sleep Time (TST)(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
- Sleep Onset Latency (SOL)(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
- Negative Affect(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
- Sleep Efficiency (SE)(Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks))
研究者
Chung Jung Mun
Assistant Professor
Arizona State University