Adjunctive Bright Light Therapy for Opioid Use Disorder

Last updated: July 29, 2024
Sponsor: Arizona State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Restless Leg Syndrome

Insomnia

Treatment

Wearable bright light therapy device

Wearable placebo light therapy device

Clinical Study ID

NCT05459922
STUDY00015561
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 scoreof ≥10

  • enrolled in outpatient medication-assisted treatment for OUD (i.e., either methadoneor 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

Exclusion Criteria:

  • lifetime history of bipolar disorder or mania

  • current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medicalhistory

  • 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., impendingjail 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

Study Design

Total Participants: 23
Treatment Group(s): 2
Primary Treatment: Wearable bright light therapy device
Phase:
Study Start date:
October 23, 2022
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Arizona State University

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

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