Adjunctive Bright Light Therapy for Opioid Use Disorder

Sponsor

Arizona State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05459922

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder Sleep Disturbance	Device: Wearable bright light therapy device Device: Wearable placebo light therapy device	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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 ambulatory monitoring.	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.
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 ambulatory monitoring.	Device: 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®.

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 ambulatory monitoring.

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.

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 ambulatory monitoring.

Device: 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®.

Outcome Measures

Primary Outcome Measures

Feasibility--drop-out rate [At 2 weeks post-treatment]
From enrollment to post-treatment assessment
Feasibility--adherence to intervention [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 [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 [Baseline and 2 weeks post-treatment]
Probabilistic Reward Task will be used to assess reward learning
Changes in reward valuation [Baseline and 2 weeks post-treatment]
Effort Expenditure for Reward Task will be used to
Changes in reward responsiveness [Baseline and 2 weeks post-treatment]
Monetary Incentive Delay Task will be used to reward responsiveness

Secondary Outcome Measures

Total Sleep Time (TST) [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.
Sleep Onset Latency (SOL) [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.
Wake After Sleep Onset (WASO) [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.
Sleep Efficiency (SE) [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 Opioid Craving [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 5-point Likert scale, with 1 being "Not at All" and 5 being "Extremely." This will be measured via ecological momentary assessment multiple times per day through random prompts. Higher scores indicate greater opioid craving.
Illicit Opioid Use Frequency [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 through random prompts and self-initiated event-contingent reports via ecological momentary assessments. The timing of administration will be pseudo-randomized, but will broadly cover morning, midday and evening.
Negative Affect [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 measured via ecological momentary assessment multiple times per day through random prompts. Higher scores indicate greater negative affect.
Positive Affect [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 measured via ecological momentary assessment multiple times per day through random prompts. Higher scores indicate greater positive affect.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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., methadone treatment)
been in medication-assisted treatment for at least 3 months
≥3 weeks of stable methadone 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