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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
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.
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®.
Arizona State University
Phoenix, Arizona, United States
Feasibility--drop-out rate
From enrollment to post-treatment assessment
Time frame: 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
Time frame: 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.
Time frame: At 2 weeks post-treatment
Changes in reward learning
Probabilistic Reward Task will be used to assess reward learning
Time frame: Baseline and 2 weeks post-treatment
Changes in reward valuation
Delayed Discounting Task will be used to assess reward valuation
Time frame: 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.
Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)