Adjunctive Bright Light Therapy for Opioid Use Disorder

NCT05459922 | Completed

• 1 other identifier: STUDY00015561
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder; Sleep Disturbance

Keywords

opioid use disorder; bright light therapy; reward function; methadone

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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)

• Wake After Sleep Onset (WASO)

  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)

• Illicit Opioid Use Frequency

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

Study Arms (2)

Bright light therapy group

EXPERIMENTAL

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

Dim light (placebo) group

PLACEBO COMPARATOR

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

Interventions

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.

Bright light therapy group

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®.

Dim light (placebo) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Chung Jung Mun, Ph.D.

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 15, 2022
• Study Start: October 23, 2022
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)