The Effect of Light Intervention on Recovery in Individuals With Opioid Use Disorder (OUD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Dim light melatonin onset (DLMO)
研究概览
简要总结
Opioid use disorder (OUD) is a chronic relapsing disorder and is well-known for its high-risk rate of overdoses and death. In OUD, sleep and circadian disruptions are highly prevalent, interfere with opioid maintenance treatment outcomes and increase the risk of relapse. So far, commonly used pharmacological sleep treatments fail to improve sleep or decrease illicit drug use in OUD. Thus, there is an urgent need to fill this research gap.
Previous work showed that OUD patients who were receiving opioid agonist treatment (MOUD+) exhibited greater irregularity of sleep-wake cycle. In OUD patients, sleep-wake irregularity was associated with years of heroin use and low light exposure. Bright light therapy (BLT) is a very promising circadian/sleep intervention for several sleep, psychiatric and neurological disorders. BLT improved circadian, sleep outcomes and negative mood. In a pilot study, BLT improved objective and subjective sleep in patients with alcohol use disorder. Here investigators proposed an intervention study for MOUD+ patients to determine effects of BLT as an adjunct treatment on sleep and circadian outcomes including endogenous circadian rhythm, rest-activity rhythm and sleep neurophysiology (Primary objectives); and to determine effects of BLT on brain function and on clinical outcomes including negative affect, craving and illicit drug use and whether changes in sleep and circadian rhythm mediate the BLT effect on brain recovery and clinical outcomes (Secondary objectives).
Fifty MOUD+ will be assigned either to bright light or to dim light group for 2 weeks. The groups will be matched for age, sex, race and OUD medication (Methadone vs Buprenorphine). The study will run throughout the year such that it occurs during all seasons. Light exposure will be measured with light sensor for additional control. All MOUD+ participants will have a daily 30-min light exposure (bright or dim blue light) in the morning after their habitual wake-up time and will be asked to avoid evening light before bed. Dim light melatonin onset, accelerometer, sleep EEG and questionnaires will be used to measure objective and subjective sleep and circadian outcomes. For brain function, cue-reactivity task will be used to assess brain activation during drug craving. Resting state functional connectivity and brain state dynamics will be assessed by rsfMRI. Mood, opiate craving and illicit drug use will be assessed. All measures will be repeated before and after the treatment. Investigators expect that BLT would normalize sleep and circadian outcomes, attenuate impairments in brain functions and result in better clinical outcomes. If successful, light therapy will provide add-on benefits to opioid agonist therapy and facilitate OUD recovery process.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants
- •Between 18 and 60 years old
- •Fluent in English
- •Able to provide written informed consent
- •DSM-5 diagnosis of an OUD.
- •≥12 months of lifetime opioid use
- •Positive on urine drug screen for buprenorphine or methadone
- •Receiving opioid agonist therapy for OUD (e.g., methadone or buprenorphine) with a stable dose for the past month. Must have been stabilized on OMT medication, since the increasing of doses during induction phase might interfere with outcomes and unstable patients might experience strong withdrawal symptoms in the morning which makes them unsuitable for a home-based BLT.
- •Other substance use was not exclusionary, but opioids were identified as primary.
排除标准
- •All Participants
- •Head trauma with loss of consciousness for more than 30 minutes as determined by medical history.
- •history of seizures/epilepsy.
- •Pregnant and/or currently breast-feeding.
- •Presence of ferromagnetic objects in the body that are contraindicated for MRI or fear of enclosed spaces.
- •Eye disease including disease of the anterior and posterior segment of the eye, cataracts, retinopathy, glaucoma, amblyopia, scotoma, color or night blindness, corneal pathologies, macular degeneration, or retinitis pigmentosa reported by history or identified by eye exam
- •History of eye surgery
- •Chronic migraine triggered by bright light
- •worked night shift or traveled across>2 time zones in the past month
- •diagnosis of substance use disorder other than for opioids that was deemed to be primary
- •lifetime diagnosis of schizophrenia, bipolar disorder, or suicidality.
- •History of light treatment
- •Unstable dose of psychiatric medication (hypnotics, sleep aids, and antidepressants must be stable for 30 days before and during the study)
- •Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder including substance use disorder (except for nicotine/caffeine).
- •Current DSM-5 sleep-wake disorders including insomnia disorder
研究组 & 干预措施
Experimental light
MOUD participants
干预措施: AYO light glasses (experimental) (Device)
Comparison light
MOUD participants
干预措施: AYO light glasses (comparator) (Device)
Healthy control
结局指标
主要结局
Dim light melatonin onset (DLMO)
时间窗: the day directly before and after the intervention
DLMO is assessed for endogenous circadian phase.Participants will be asked to remain awake in dim light \< 5 lux. Salivary melatonin sample will be collected hourly and start 5h before habitual bedtime. Melatonin concentration will be later radioimmunoassayed. DLMO will be calculated as the time when melatonin concentration exceeds and remains above 4 pg/mL.
melatonin metabolites level
时间窗: the day directly before and after the intervention
Participants will be asked to collect their first morning urine void (overnight urine) upon waking. Urinary metabolite of melatonin 6-sulphatoxymelatonin (aMT6s) will be quantified and normalized to urinary creatinine concentrations to account for variations in urine concentration.
Sleep-wake regularity
时间窗: From the enrollment to the end of the treatment at 24 days
To record rest-activity/sleep-wake patterns, participants are asked to wear a triaxial accelerometer placed on the non-dominant wrist continuously throughout the study.
Total sleep duration
时间窗: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
total sleep duration (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
N3 sleep
时间窗: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
N3 sleep (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
REM sleep
时间窗: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
REM sleep (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
sleep spindle
时间窗: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
Amount of sleep spindle will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
次要结局
- brain signiture of craving measured by cue reactivity task(the day prior to the intervention and the day after the intervention)
- brain functions during resting state(the day before and after light intervention)
- Ecological momentary assessment (EMA)(From the enrollment to the end of the treatment at 24 days)
研究者
Rui Zhang
Assistant Professor
University of Alabama at Birmingham