Adjunctive Bright Light Therapy for Opioid Use Disorder

Arizona State University (ASU)

Status: Enrolling

Conditions: Opioid Use Disorder; Sleep Disturbance

Treatments: Device: Wearable bright light therapy device; Device: Wearable placebo light therapy device

Study type: Interventional

Funder types: Other

Identifiers

NCT05459922

STUDY00015561

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups, including a placebo group

Bright light therapy group

Experimental group

Description:

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.

Treatment:

Device: Wearable bright light therapy device

Dim light (placebo) group

Placebo Comparator group

Description:

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.

Treatment:

Device: Wearable placebo light therapy device