Clinical trial NCT05459922: Adjunctive Bright Light Therapy for Opioid Use Disorder
Official title: Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Sleep Disturbance
Keywords: opioid use disorder
bright light therapy
reward function
methadone
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility--drop-out rate
timeFrame: At 2 weeks post-treatment
measure: Feasibility--adherence to intervention
timeFrame: At 2 weeks post-treatment
measure: Acceptability of the intervention
timeFrame: At 2 weeks post-treatment
measure: Changes in reward learning
timeFrame: Baseline and 2 weeks post-treatment
measure: Changes in reward valuation
timeFrame: Baseline and 2 weeks post-treatment
measure: Changes in Opioid Craving
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary outcomes:
measure: Total Sleep Time (TST)
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
measure: Sleep Onset Latency (SOL)
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
measure: Wake After Sleep Onset (WASO)
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
measure: Sleep Efficiency (SE)
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
measure: Illicit Opioid Use Frequency
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
measure: Negative Affect
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
measure: Positive Affect
timeFrame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Chung Jung Mun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: