Sleep Disturbance Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Arizona State University | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University |
United States,
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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