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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05459922
Other study ID # STUDY00015561
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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