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Virus Therapy

Active treatment for Opioid Use Disorder

N/A

Recruiting

Research Sponsored by MindLight, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of the study

Awards & highlights

Study Summary

This trial will test a new treatment for opiate addiction using a 4-minute intense near infra-red light therapy on a specific part of the brain. The treatment will be compared to a fake treatment on

Who is the study for?

This trial is for adults aged 18-65 with mild to moderately severe opioid use disorder, who have been using non-prescribed opioids at least once a week for over two months. They must not be pregnant and should be interested in trying a new treatment as part of a 26-week study.Check my eligibility

What is being tested?

The study tests unilateral transcranial photobiomodulation—a novel therapy involving intense near-infrared light stimulation on one side of the brain. Participants will receive either this active treatment or a sham (placebo) version, up to twice weekly for 25 weeks.See study design

What are the potential side effects?

Potential side effects are not specified but may include discomfort or changes in mood/behavior due to brain stimulation. The safety profile will be closely monitored given that it's an innovative treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 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

percent of participants that achieve abstenense

Secondary outcome measures

Overall clinical status

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active treatmentExperimental Treatment1 Intervention

Participants in this group will receive a 4-minute unilateral transcranial photobiomodulation treatment.

Group II: treatmentPlacebo Group1 Intervention

Half of the participants will receive sham. Treatment will be 2 times a week for 4 weeks, then once a week for 20 weeks and then a followup 1 week later. The sham device is identical to the active device except that it has foil over the LED.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

MindLight, LLCLead Sponsor

2 Previous Clinical Trials

61 Total Patients Enrolled

Mclean HospitalOTHER

213 Previous Clinical Trials

21,564 Total Patients Enrolled

Frequently Asked Questions

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

Is this study actively seeking participants at the present time?

"According to data on clinicaltrials.gov, this study is presently seeking participants. It was initially uploaded on 1/22/2024 and last modified on 3/24/2024."

Answered by AI

What are the specific criteria for eligible participants to be enrolled in this medical study?

"This trial is actively seeking 130 individuals aged between 18 and 65 who are currently grappling with opioid use disorder. Eligible participants must undergo the following process: Upon arrival, they will receive a consent form to peruse at their own pace. After reviewing it, study personnel will clarify any doubts before obtaining the subject's signature on the document. Subsequently, study staff members will also sign this form and provide a duplicate for the participant's personal records. The ideal candidates should exhibit mild-to-moderately severe symptoms of opioid use disorder according to DSM-5 criteria (with scores ranging from 2 to 7) and manifest interest"

Answered by AI