Adjunctive Bright Light Therapy for Opioid Use Disorder

Sleep Disturbance Clinical Trial

Official title:

Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459922
• Other study ID #: STUDY00015561
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2022
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Arizona State University
• Contact: Chung Jung Mun, Ph.D.
• Phone: 602-496-2992
• Email: ChungJung.Mun[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Opioid Use Disorder
• Opioid-Related Disorders
• Parasomnias
• Sleep Disturbance
• Substance-Related Disorders

Intervention

Device:
• 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.
• 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®.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility--drop-out rate	From enrollment to post-treatment assessment	At 2 weeks post-treatment
Primary	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
Primary	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
Primary	Changes in reward learning	Probabilistic Reward Task will be used to assess reward learning	Baseline and 2 weeks post-treatment
Primary	Changes in reward valuation	Delayed Discounting Task will be used to assess reward valuation	Baseline and 2 weeks post-treatment
Primary	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	Total Sleep Time (TST)	TST is defined as the total number of minutes asleep between the time a participant goes to bed at night and the time a participant gets out of bed in the morning. Total Sleep Time will be derived from wrist-worn actigraphy.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary	Sleep Onset Latency (SOL)	SOL is defined as the duration of time from turning the light off to falling asleep. SOL will be derived from wrist-worn actigraphy.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary	Wake After Sleep Onset (WASO)	WASO is defined as the total number of minutes awake following sleep initiation and before participants get out of bed in the morning. WASO will be derived from wrist-worn actigraphy.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary	Sleep Efficiency (SE)	SE is defined as sleep latency plus wake after sleep onset, and is calculated as the number of sleep minutes divided by the number of minutes in bed multiplied by 100. SE will be derived from wrist-worn actigraphy.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary	Illicit Opioid Use Frequency	Illicit opioid use 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.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary	Negative Affect	To assess daily negative affect, participants will be asked to rate several adjectives that describe negative affect on a 5-point Likert scale, with 1 being "No" and 5 being "Extremely." Items are based upon the Positive and Negative Affect Schedule. Negative affect 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 negative affect.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary	Positive Affect	To assess daily positive affect, participants will be asked to rate several adjectives that describe positive affect on a 5-point Likert scale, with 1 being "No" and 5 being "Extremely." Items are based upon the Positive and Negative Affect Schedule. Positive affect 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 positive affect.	Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)