Adjunctive Bright Light Therapy for Opioid Use Disorder

Study Overview
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Brief Summary
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Investigators propose to conduct a pilot single-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.

Detailed Description
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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 single-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.

Official Title
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Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study

Conditions
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Opioid Use Disorder, Sleep Disturbance

Intervention / Treatment
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* Device: Wearable bright light therapy device
* Device: Wearable placebo light therapy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright light therapy group<br>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. | Device: Wearable bright light therapy device<br>* Light treatment glasses (Re-timer®) will be used to deliver bright light therapy. This device is available commercially and allows participants to freely move around while receiving light from LEDs positioned below the eyes. Re-timer® can be worn over glasses and does not interfere with vision, reading, or computer work.<br>|
| Placebo Comparator: Dim light (placebo) group<br>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. | Device: Wearable placebo light therapy device<br>* The placebo Re-timer® emits light intensity to a level that will not impact sleep and circadian timing and appears identical to the original Re-timer®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility--drop-out rate | From enrollment to post-treatment assessment | At 2 weeks post-treatment | 
| Feasibility--adherence to intervention | The number of days bright light therapy was completed divided by the total number of treatment days | At 2 weeks post-treatment | 
| Acceptability of the intervention | 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. | At 2 weeks post-treatment | 
| Changes in reward learning | Probabilistic Reward Task will be used to assess reward learning | Baseline and 2 weeks post-treatment | 
| Changes in reward valuation | Delayed Discounting Task will be used to assess reward valuation | Baseline and 2 weeks post-treatment | 
| Changes in Opioid Craving | 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. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time (TST) | TST is defined as the total number of minutes asleep between the time a participant goes to bed at night and the time a participant gets out of bed in the morning. Total Sleep Time will be derived from wrist-worn actigraphy. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 
| Sleep Onset Latency (SOL) | SOL is defined as the duration of time from turning the light off to falling asleep. SOL will be derived from wrist-worn actigraphy. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 
| Wake After Sleep Onset (WASO) | WASO is defined as the total number of minutes awake following sleep initiation and before participants get out of bed in the morning. WASO will be derived from wrist-worn actigraphy. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 
| Sleep Efficiency (SE) | SE is defined as sleep latency plus wake after sleep onset, and is calculated as the number of sleep minutes divided by the number of minutes in bed multiplied by 100. SE will be derived from wrist-worn actigraphy. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 
| Illicit Opioid Use Frequency | Illicit opioid use 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. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 
| Negative Affect | To assess daily negative affect, participants will be asked to rate several adjectives that describe negative affect on a 5-point Likert scale, with 1 being No and 5 being Extremely. Items are based upon the Positive and Negative Affect Schedule. Negative affect 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 negative affect. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 
| Positive Affect | To assess daily positive affect, participants will be asked to rate several adjectives that describe positive affect on a 5-point Likert scale, with 1 being No and 5 being Extremely. Items are based upon the Positive and Negative Affect Schedule. Positive affect 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 positive affect. | Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid use disorder, bright light therapy, reward function, methadone