Opioid Use DisorderNCT05459922
Adjunctive Bright Light Therapy for Opioid Use Disorder
A study testing Wearable bright light therapy device in people with Opioid Use Disorder and Sleep Disturbance, run by Arizona State University at 1 site in United States.
Trial summary
Investigators propose to conduct a pilot double-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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Sleep Disturbance
- What is being tested?
- Wearable bright light therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2022to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study
Investigators propose to conduct a pilot double-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.
Read the 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 double-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.
- Conditions
- Opioid Use Disorder, Sleep Disturbance
- Being tested
- Wearable bright light therapy device, Wearable placebo light therapy device
- Keywords
- opioid use disorder, bright light therapy, reward function, methadone
- Medical subject headings
- Opioid-Related Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable bright light therapy deviceDevice
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 deviceDevice
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®.
| Study group | Role | What they receive |
|---|---|---|
| Bright light therapy group | Experimental | 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. Receives: Device: Wearable bright light therapy device |
| Dim light (placebo) group | Placebo comparator | 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. Receives: Device: Wearable placebo light therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility--drop-out rate
From enrollment to post-treatment assessment
Measured: At 2 weeks post-treatment
Feasibility--adherence to intervention
The number of days bright light therapy was completed divided by the total number of treatment days
Measured: At 2 weeks post-treatment
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.
Measured: At 2 weeks post-treatment
Changes in reward learning
Probabilistic Reward Task will be used to assess reward learning
Measured: Baseline and 2 weeks post-treatment
Changes in reward valuation
Delayed Discounting Task will be used to assess reward valuation
Measured: Baseline and 2 weeks post-treatment
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Secondary outcomes (7)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
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.
Measured: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start23 Oct 2022
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Jung Mun, Arizona State University
- Investigators
- Chung Jung Mun, Ph.D., Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459922
- Sponsor's protocol ID
- STUDY00015561
- Status last verified
- Jul 2026
- First submitted
- 7 Jun 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Wearable Bright Light Therapy for Patients With Opioid Use Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT05459922
- Acronym / sponsor ID
- STUDY00015561
- Conditions
- Opioid Use Disorder, Sleep Disturbance
- Keywords
- opioid use disorder, bright light therapy, reward function, methadone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators propose to conduct a pilot double-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 double-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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright light therapy group | Experimental | Device: Wearable bright light therapy deviceParticipants 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. |
| Dim light (placebo) group | Placebo comparator | Device: Wearable placebo light therapy deviceParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable bright light therapy deviceLight 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. | Device | Bright light therapy group |
| Wearable placebo light therapy deviceThe 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®. | Device | Dim light (placebo) group |
Primary outcome
Feasibility--drop-out rate
Time frame: At 2 weeks post-treatment
From enrollment to post-treatment assessment
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
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.
Changes in reward learning
Time frame: Baseline and 2 weeks post-treatment
Probabilistic Reward Task will be used to assess reward learning
Changes in reward valuation
Time frame: Baseline and 2 weeks post-treatment
Delayed Discounting Task will be used to assess reward valuation
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.
7 secondary outcomes
Total Sleep Time (TST)
Time frame: 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)
Wake After Sleep Onset (WASO)
Time frame: 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)
Illicit Opioid Use Frequency
Time frame: 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)
Positive Affect
Time frame: Daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung Jung Mun, Ph.D. principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable bright light therapy device in people with Opioid Use Disorder and Sleep Disturbance, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility--drop-out rate (time frame: At 2 weeks post-treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.