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Completed

NCT Number: NCT05459922

Adjunctive Bright Light Therapy for Opioid Use Disorder

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable bright light therapy device

Device

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.

Wearable placebo light therapy device

Device

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®.

Primary outcomes

  1. Feasibility--drop-out rate

    Time frame: At 2 weeks post-treatment

    From enrollment to post-treatment assessment

  2. Feasibility--adherence to intervention

    Time frame: At 2 weeks post-treatment

    The number of days bright light therapy was completed divided by the total number of treatment days

  3. Acceptability of the intervention

    Time frame: 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.

  4. Changes in reward learning

    Time frame: Baseline and 2 weeks post-treatment

    Probabilistic Reward Task will be used to assess reward learning

  5. Changes in reward valuation

    Time frame: Baseline and 2 weeks post-treatment

    Delayed Discounting Task will be used to assess reward valuation

  6. Changes in Opioid Craving

    Time frame: 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.

Secondary outcomes

  1. Total Sleep Time (TST)

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    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.

  2. Sleep Onset Latency (SOL)

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    SOL is defined as the duration of time from turning the light off to falling asleep. SOL will be derived from wrist-worn actigraphy.

  3. Wake After Sleep Onset (WASO)

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    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.

  4. Sleep Efficiency (SE)

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    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.

  5. Illicit Opioid Use Frequency

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    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.

  6. Negative Affect

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    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.

  7. Positive Affect

    Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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