Back to resultsAdjunctive Bright Light Therapy for Opioid Use Disorder
Primary Purpose
Opioid Use Disorder, Sleep Disturbance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable bright light therapy device
Wearable placebo light therapy device
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder focused on measuring opioid use disorder, bright light therapy, reward function, methadone
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
Sites / Locations
- Arizona State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bright light therapy group
Dim light (placebo) group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Feasibility--drop-out rate
From enrollment to post-treatment assessment
Feasibility--adherence to intervention
The number of days bright light therapy was completed divided by the total number of treatment days
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.
Changes in reward learning
Probabilistic Reward Task will be used to assess reward learning
Changes in reward valuation
Delayed Discounting Task will be used to assess reward valuation
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05459922
First Posted
June 7, 2022
Last Updated
October 20, 2023
Sponsor
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT05459922
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Sleep Disturbance
Keywords
opioid use disorder, bright light therapy, reward function, methadone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bright light therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Dim light (placebo) group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wearable bright light therapy device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wearable placebo light therapy device
Intervention Description
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®.
Primary Outcome Measure Information:
Title
Feasibility--drop-out rate
Description
From enrollment to post-treatment assessment
Time Frame
At 2 weeks post-treatment
Title
Feasibility--adherence to intervention
Description
The number of days bright light therapy was completed divided by the total number of treatment days
Time Frame
At 2 weeks post-treatment
Title
Acceptability of the intervention
Description
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.
Time Frame
At 2 weeks post-treatment
Title
Changes in reward learning
Description
Probabilistic Reward Task will be used to assess reward learning
Time Frame
Baseline and 2 weeks post-treatment
Title
Changes in reward valuation
Description
Delayed Discounting Task will be used to assess reward valuation
Time Frame
Baseline and 2 weeks post-treatment
Title
Changes in Opioid Craving
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary Outcome Measure Information:
Title
Total Sleep Time (TST)
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Title
Sleep Onset Latency (SOL)
Description
SOL is defined as the duration of time from turning the light off to falling asleep. SOL will be derived from wrist-worn actigraphy.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Title
Wake After Sleep Onset (WASO)
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Title
Sleep Efficiency (SE)
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Title
Illicit Opioid Use Frequency
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Title
Negative Affect
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Title
Positive Affect
Description
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.
Time Frame
Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung Jung Mun, Ph.D.
Phone
602-496-2992
Email
ChungJung.Mun@asu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Winsick, M.S.
Phone
602-496-0665
Email
nmwinsic@asu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung Jung Mun, Ph.D.
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung Jung Mun, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjunctive Bright Light Therapy for Opioid Use Disorder
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