- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05459922
Adjunctive Bright Light Therapy for Opioid Use Disorder
October 20, 2023 updated by: Chung Jung Mun, Arizona State University
Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chung Jung Mun, Ph.D.
- Phone Number: 602-496-2992
- Email: ChungJung.Mun@asu.edu
Study Contact Backup
- Name: Nina Winsick, M.S.
- Phone Number: 602-496-0665
- Email: nmwinsic@asu.edu
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Arizona State University
-
Principal Investigator:
- Chung Jung Mun, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bright light therapy group
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.
|
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.
|
Placebo Comparator: Dim light (placebo) group
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.
|
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®.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility--drop-out rate
Time Frame: At 2 weeks post-treatment
|
From enrollment to post-treatment assessment
|
At 2 weeks post-treatment
|
Feasibility--adherence to intervention
Time Frame: At 2 weeks post-treatment
|
The number of days bright light therapy was completed divided by the total number of treatment days
|
At 2 weeks post-treatment
|
Acceptability of the intervention
Time Frame: At 2 weeks post-treatment
|
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
|
Changes in reward learning
Time Frame: Baseline and 2 weeks post-treatment
|
Probabilistic Reward Task will be used to assess reward learning
|
Baseline and 2 weeks post-treatment
|
Changes in reward valuation
Time Frame: Baseline and 2 weeks post-treatment
|
Delayed Discounting Task will be used to assess reward valuation
|
Baseline and 2 weeks post-treatment
|
Changes in Opioid Craving
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Sleep Time (TST)
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Sleep Onset Latency (SOL)
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Wake After Sleep Onset (WASO)
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Sleep Efficiency (SE)
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Illicit Opioid Use Frequency
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Negative Affect
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Positive Affect
Time Frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chung Jung Mun, Ph.D., Arizona State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2022
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
June 7, 2022
First Submitted That Met QC Criteria
July 12, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 20, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00015561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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