Adjunctive Bright Light Therapy for Opioid Use Disorder

NCT ID: NCT05459922

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-23
• Study Completion Date: 2026-05-31

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.

Detailed Description

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.

Conditions

Opioid Use Disorder; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bright light therapy group

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.

Group Type: EXPERIMENTAL

Wearable bright light therapy device

Intervention Type: 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.

Dim light (placebo) group

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.

Group Type: PLACEBO_COMPARATOR

Wearable placebo light therapy device

Intervention Type: 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®.

Interventions

Wearable bright light therapy 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.

Intervention Type: DEVICE

Wearable placebo light therapy 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®.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Chung Jung Mun

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chung Jung Mun, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chung Jung Mun, Ph.D.

Role: CONTACT

ChungJung.Mun@asu.edu

602-496-2992

Nina Winsick, M.S.

Role: CONTACT

nmwinsic@asu.edu

602-496-0665

Other Identifiers

STUDY00015561

Identifier Type: -

Identifier Source: org_study_id