Clinical Trial 42792

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Newton Highlands, MA 02461


Study Summary:

MindLight Research Study

This study is conducted by Fredric Schiffer, MD who is the Founder and President of MindLight, LLC. Dr. Schiffer is a psychiatrist who specializes in the treatment of opiate addiction. The research will be conducted at the MindLight offices at 30 Lincoln Street, Newton Highlands, MA. Some of this research will be conducted also at The Developmental Biopsychiatry Research Program at McLean Hospital, 115 Mill Street, Belmont, MA by Martin Teicher, MD, PhD.

The study will involve a painless, 4-minute treatment with a very bright LED (light-emitting diode that puts out light when an electrical charge passes through the diode) placed on your forehead that is intended to reduce drug cravings and improve your psychological wellbeing.  Our study wishes to gain further evidence about the treatment's safety, and although a near-infrared device for the head is sold on the internet and is approved by the FDA for safety, we do not have FDA approval for the treatment of drug abuse, and unforeseen side-effects are possible. 

The purpose of this study is to see if the active treatments (compared to sham treatments) reduce opiate cravings and relapses. We hope but are not sure that this study and future studies will lead to a new and effective treatment for opiate abuse.

If you agree to participate, you will come twice a week for four weeks to the MindLight office for a 4-minute treatment active or sham light treatment, and each treatment will be preceded and followed by about 15minutes of study questions about how you feel.  You will also be given a computer test which shows photographs of angry men on one side of the screen or the other.  You will do this for 4 consecutive weeks. After the 4-week treatment period, you will be asked to return to the laboratory for 3 consecutive weekly follow-up 30 to 60-minute sessions, to evaluate the value of the treatments for your opioid cravings and use.  Throughout the treatment and the follow-up phases, you will be asked to give a urine drug screen. At the conclusion of the study, you will be given a drug hair analysis.

 



Criteria:

You must be 18 to 70 years of age. You must be able to come to the clinic for an intake session and then twice a week 4 weeks, followed by 3 weekly follow up sessions.  For the study to work, you will have to come for consecutive weeks and try not to miss a session to its completion. Dropouts and missing data make evaluating the data difficult. Completed studies will show how safe and effective this treatment is. About 30 published studies show this treatment to be without notable side effects, as does our clinical experience over 2 1/2 years, but we will be vigilant for unforeseen side effects. Interested participants will call or email Dr. Schiffer who will schedule a telephone screen to rule out some conditions and assure that you would be a good candidate for the study. You will come for an initial session to go over the consent form and have some initial testing. You will then be scheduled for the 2x/wk four-week treatments and the once a week follow-up sessions.


Qualified Participants May Receive:

 Your participation is completely voluntary and if you choose not to participate or decide to drop out, you can still continue your usual treatment.  You will be paid $420 for the study as follows: You will be paid $30 for the initial session, which will be up to 1 hour and $30 for each treatment and follow-up sessions which will be 30 to 60 minutes.  You will be paid a $90 bonus when you complete the study.  You will also be given a Charlie Card if you take public transportation to the study.


Study is Available At:

Sameem Associates
24 Lincoln Street
Newton Highlands, MA 02461
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If you or someone you care for is interested in participating in this clinical trial and lives within 25 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.