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Behavioral Intervention
Mindfulness Therapy for Heroin Addiction (MORE Trial)
N/A
Recruiting
Led By Rita Goldstein, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DSM-5 diagnosis of OUD with heroin as the primary drug of choice
Males and Females 18-64 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months enrollment
Awards & highlights
MORE Trial Summary
This trial uses MRIs to study how different types of therapy affect the brains of people with opioid addiction, in hopes of finding better treatments.
Who is the study for?
This trial is for adults aged 18-64 with heroin addiction, specifically those who have chosen heroin as their primary drug and are stabilized on methadone or similar treatments. It's not suitable for individuals with metal implants, serious medical conditions like heart disease, a history of significant head trauma, neurological diseases, schizophrenia, autism spectrum disorders, or infectious diseases such as Hepatitis B/C or HIV/AIDS.Check my eligibility
What is being tested?
The study compares two types of behavioral group therapies to see which is more effective in treating opioid addiction. Participants will undergo brain scans before and after the 8-week therapy sessions to observe changes in reward processing and impulse control. The effectiveness will be evaluated at different stages: before treatment starts, right after it ends, and three months later.See study design
What are the potential side effects?
Since this trial involves behavioral group therapies rather than medication or invasive procedures, there are no direct physical side effects associated with the interventions being tested.
MORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My main addiction is to heroin.
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I am between 18 and 64 years old.
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I understand the study and can give my consent.
Select...
I am on a stable dose of methadone or similar medication.
MORE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 3 months enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in MRI Voxel-Based Morphometry (VBM) measure
Change in Urine drug test
Change in fMRI BOLD signal acquired during resting-state functional connectivity
+3 moreMORE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral group therapy 1Experimental Treatment1 Intervention
8-weeks of group therapy
Group II: Behavioral group therapy 2Active Control1 Intervention
8-weeks of group therapy
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
524,976 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,673 Total Patients Enrolled
University of UtahOTHER
1,099 Previous Clinical Trials
1,778,389 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of brain-related neurological diseases, including seizures.My main addiction is to heroin.I have had a head injury that made me lose consciousness.I have a condition like high blood pressure, diabetes, cancer, an autoimmune disease, or an infection such as Hepatitis or HIV.I am between 18 and 64 years old.I have been diagnosed with schizophrenia or a developmental disorder like autism.I understand the study and can give my consent.I am on a stable dose of methadone or similar medication.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral group therapy 2
- Group 2: Behavioral group therapy 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it permissible for octogenarians to participate in this experiment?
"Participants must be 18 years of age or older, but not exceed the upper limit of 64 for this clinical trial."
Answered by AI
Is enrollment open for this medical experiment at present?
"Per information listed on clinicaltrials.gov, this medical study is still actively recruiting patients. The trial was first announced in October 2020 and received its latest update two years later to the date."
Answered by AI
Could I potentially be included in this research program?
"Eligibility criteria for this heroin-focused study stipulates that applicants must be aged between 18 and 64. 300 total participants are required to complete the trial."
Answered by AI
How many volunteers are partaking in this experiment?
"Correct. Clinicaltrials.gov's records indicate that this medical trial, which opened on October 21st 2020, is actively recruiting patients. 300 individuals are needed from one healthcare institution to take part in the experiment."
Answered by AI
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