Mindfulness vs. heroin: brain scans may reveal who recovers
NCT ID NCT04112186
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial uses brain scans to see whether 8 weeks of mindfulness-based group therapy changes how the brain processes reward, craving, and self-control in people with heroin addiction. About 157 adults on medication for opioid use disorder will be randomly assigned to mindfulness therapy or a standard group therapy. Researchers will compare brain activity before and after treatment and track drug use for three months afterward. The goal is to find brain markers that could predict recovery and help personalize addiction treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mindfulness-based group therapy
- What this could lead to
- If it works, this could help identify brain-based markers that predict who benefits most from mindfulness therapy for opioid addiction, enabling more personalized treatment.
- What could go wrong
- This is an early-stage brain-imaging study, not a large treatment trial. It may not show clear differences between therapy types, and brain changes don't always translate to real-world recovery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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157 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to understand and give informed consent * Males and Females 18-64 years of age * DSM-5 diagnosis of OUD with heroin as the primary drug of choice * Stabilized on methadone or other form of MAT. Inclusion criteria for healthy controls: \- The same as inclusion criteria 1-2 above; dependence on nicotine or caffeine is non-exclusionary. Exclusion Criteria: * DSM-5 diagnosis for schizophrenia or developmental disorder (e.g., autism) * Head trauma with loss of consciousness * History of neurological disease of central origin including seizures * Cardiovascular disease including high blood pressure and/or other medical conditions, including metabolic, endocrinological,oncological or autoimmune diseases, and infectious diseases common in iOUD including Hepatitis B and C or HIV/AIDS * Metal implants or other MR contraindications Exclusion criteria for healthy control subjects: \- The same, except history of any drug use disorder is prohibitive.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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