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Bright Light Therapy for Opioid Use Disorder

N/A
Recruiting
Led By Chung Jung Mun, Ph.D.
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 65
Past 2 weeks of insomnia as evidenced by Insomnia Severity Index (ISI) total score of ≥10
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
Awards & highlights

Study Summary

This trialstudies the effects of bright light therapy on opioid use disorder patients undergoing medication-assisted treatment.

Who is the study for?
This trial is for English-speaking adults aged 18-65 with opioid use disorder who are in outpatient treatment, have had stable medication doses for a month, and suffer from insomnia. They must own a smartphone. People with bipolar disorder, high risk of sleep apnea, eye conditions or surgeries, certain medication usage, recent night shift work or travel outside Arizona time zone can't participate.Check my eligibility
What is being tested?
The study tests the effects of bright light therapy using wearable devices on patients' reward system functioning during opioid addiction treatment. Participants will be randomly assigned to either real bright light therapy or a placebo device without knowing which one they receive.See study design
What are the potential side effects?
Potential side effects may include discomfort due to bright light exposure such as eye strain or headache. Since it's non-invasive and doesn't involve drugs, serious side effects are unlikely but could include mood changes if underlying conditions like bipolar disorder were undiagnosed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I have been experiencing significant insomnia for the past 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily for the 1 week at baseline and throughout the treatment period (up to 2 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the intervention
Changes in Opioid Craving
Changes in reward learning
+3 more
Secondary outcome measures
Illicit Opioid Use Frequency
Negative Affect
Positive Affect
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bright light therapy groupExperimental Treatment1 Intervention
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.
Group II: Dim light (placebo) groupPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
282 Previous Clinical Trials
108,951 Total Patients Enrolled
Chung Jung Mun, Ph.D.Principal InvestigatorArizona State University
1 Previous Clinical Trials
20 Total Patients Enrolled
Chung Jung Chung Jung, Ph.D.Principal InvestigatorArizona State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation extend to participants younger than seventy years of age?

"This trial is only accepting applicants aged 18 to 65. However, there are 352 clinical trials catering exclusively to minors and 992 studies tailored toward adults over the age of 65."

Answered by AI

To what extent has recruitment for this trial been successful?

"Indeed, according to the information on clinicaltrials.gov, this trial is presently recruiting participants for enrollment. The medical study was first posted on October 23rd 2022 and has since been updated as of October 24th 2022; it calls for up to 23 patients from one site alone."

Answered by AI

What requirements must potential participants fulfill for inclusion in this experiment?

"This clinical trial is seeking 23 English-speaking adults aged 18 to 65 who have experienced insomnia within the past two weeks, as indicated by a score of 10 or higher on the Insomnia Severity Index. Patients must also be enrolled in outpatient medication-assisted treatment for opioid use disorder, with at least 3 months' experience and a stable dose over the last month. A smartphone ownership is also required."

Answered by AI

What are the intended outcomes of this medical experimentation?

"The primary aim of this clinical trial, to be evaluated at 2 weeks post-treatment is the alteration in illicit opioid craving. Secondary endpoints include Wake After Sleep Onset (WASO), Daily Opioid Craving and Total Sleep Time (TST). WASO will be calculated from wrist-worn actimetry devices measuring total minutes awake after sleep onset until participants arise out of bed each morning. Similarly, TST denotes the amount of time asleep between going to bed and rising in the morning using same devices. Daily Opioid Craving shall be appraised with random ecological momentary assessment prompts asking patients to rate their urge"

Answered by AI

Are there still opportunities for individuals to participate in this experiment?

"According to clinicaltrials.gov, this study initiated recruitment on October 23rd 2022 and is still active today; the last modification was made on October 24th 2022."

Answered by AI
~1 spots leftby May 2024