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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
Must not have
History of neurological disease of central origin including seizures
Head trauma with loss of consciousness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 months enrollment
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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I am on a stable dose of methadone or similar medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of brain-related neurological diseases, including seizures.
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I have had a head injury that made me lose consciousness.
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I have been diagnosed with schizophrenia or a developmental disorder like autism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months enrollment for reporting.

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 more

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

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
526,972 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
670,082 Total Patients Enrolled
University of UtahOTHER
1,110 Previous Clinical Trials
1,788,256 Total Patients Enrolled

Media Library

Mindfulness-Oriented Recovery Enhancement (MORE) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04112186 — N/A
Opioid Use Disorder Research Study Groups: Behavioral group therapy 2, Behavioral group therapy 1
Opioid Use Disorder Clinical Trial 2023: Mindfulness-Oriented Recovery Enhancement (MORE) Highlights & Side Effects. Trial Name: NCT04112186 — N/A
Mindfulness-Oriented Recovery Enhancement (MORE) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04112186 — N/A
~55 spots leftby Jun 2025