Opiate Use DisorderMORENCT04112186
Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction
A study testing Behavioral group therapy #1 and Behavioral group therapy #2 in people with Opiate Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will be assessed before, immediately and three months after treatment. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Use Disorder
- What is being tested?
- Behavioral group therapy #1 and Behavioral group therapy #2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2020to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- The same as inclusion criteria 1-2 above; dependence on nicotine or caffeine is non-exclusionary.
Who cannot join
- 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
- The same, except history of any drug use disorder is prohibitive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction
In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will be assessed before, immediately and three months after treatment. Results could point to factors that track and predict recovery with treatment, offering clinicians markers that can be used for enhancing precision medicine with the goal of reducing morbidity and mortality associated with opiate addiction.
Read the detailed description
Over the past 15 years, the US has been affected by increasing prescription and illicit opiate/opioid abuse, addiction, and overdose. Research into the enhancement of treatment options for individuals with opiate/opioid use disorder (iOUD) is clearly a priority. The development of neuroscience-informed behavioral therapies that could be used as adjuncts to improve effectiveness of medication-assisted interventions in iOUD is a national priority, a response to the opiate crisis. This study measures the neural correlates of cognitive function and reward processing as potentially contributing to and predictive of the impact of an 8-week group therapy on addiction outcome in iOUD. Using a pre-post randomized treatment design with a 3-months follow-up, this study will examine the impact of group therapy, as add-on to methadone maintenance, on neural functional and structural plasticity, and clinical outcomes (including daily ecological momentary assessments), in treatment-seeking iOUD (with primary use of heroin). Treatment-seeking iOUD will be randomized to 8-weeks of one of two of group therapies and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Healthy controls will be scanned at similar time intervals. Clinical outcome will be assessed during, immediately after and 3-months after therapy. Results may help identify individual variability in the brain regions/circuits that support reward processing, including cue reactivity, and inhibitory control and that could change with, and predict, response to treatment, ultimately contributing to precision medicine in OUD.
- Conditions
- Opiate Use Disorder
- Being tested
- Behavioral group therapy #1, Behavioral group therapy #2
- Keywords
- Mindfulness, Opiate Use Disorder, Drug Cue Reactivity, Inhibitory Control, Salience Attribution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral group therapy #1Behavioural
Participants will participate in an 8-weeks of group therapy that uses psychological principles including mindfulness training, and could help decrease cravings for heroin and increase general well-being.
Behavioral group therapy #2Behavioural
Participants will participate in an 8-weeks of group therapy that uses psychological principles (but not including mindfulness training) and could help decrease craving for heroin and increase general well-being.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral group therapy 1 | Experimental | 8-weeks of group therapy Receives: Behavioral: Behavioral group therapy #1 |
| Behavioral group therapy 2 | Active comparator | 8-weeks of group therapy Receives: Behavioral: Behavioral group therapy #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fMRI BOLD signal during tasks of reward
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during tasks of reward at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. The reward task uses symbols of gain/win and has been shown to elicit BOLD activations in the brain's reward network.
Measured: baseline and 3 months after enrollment
Change in fMRI BOLD signal for control reactivity
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during control reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Measured: baseline and 3 months enrollment
Change in fMRI BOLD signal for cue reactivity
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during cue reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Measured: baseline and 3 months enrollment
Change in fMRI BOLD signal acquired during resting-state functional connectivity
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state functional connectivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. This method captures the synchronicity of low-frequency, spontaneous fluctuations in blood oxygen level-dependent signals that reflect fluctuations in neuronal activity between brain regions in the absence of external stimulation.
Measured: baseline and 3 months after treatment
Change in MRI Voxel-Based Morphometry (VBM) measure
Change in MRI VBM measure for grey matter volume at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. Voxel Based Morphometry is a whole-brain, fully automated, unbiased, MRI analysis technique used to detect regionally specific differences in brain tissue composition using a voxel-wise comparison across participants.
Measured: baseline and 3 months after treatment
Change in Urine drug test
Urine drug test at 3 months after treatment as compared to baseline
Measured: baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start21 Jun 2020
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opiate Use DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals with opiate use disorder (iOUD) will be randomized to one of two 8-weeks of group therapy and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Functional MRI (fMRI) scans during select tasks and at rest will assess responsiveness and connectivity of neural networks underlying impairments in Response Inhibition and Salience Attribution (iRISA). Structural MRI will assess the morphological integrity of the neural networks. A follow-up visit will take place 3 months after the second MRI scan. Healthy controls will be scanned at similar time intervals. Data collected from healthy control subjects will be used for comparative analyses.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Rita Goldstein, Icahn School of Medicine at Mount Sinai
- Investigators
- Rita Goldstein, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiNelly Alia-Klein, PhD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112186
- Sponsor's protocol ID
- GCO 18-0878
- Other IDs
- 1R01AT010627-01
- Acronym
- MORE
- Status last verified
- Jul 2026
- First submitted
- 30 Sep 2019
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant data collected during the trial, after deidentification.
Publications
Huang Y, Ceceli AO, Kronberg G, Drury KR, King SG, McClain NE, Wong YY, Boros M, Butelman ER, Gaudreault PO, Parvaz MA, Alia-Klein N, Garland EL, Goldstein RZ. Prefrontal Cortical Changes With Mindfulness-Oriented Recovery Enhancement in Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Oct 28:e263388. doi: 10.1001/jamapsychiatry.2026.3388. Online ahead of print.
PubMed 42949709
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction
- ClinicalTrials.gov ID
- NCT04112186
- Acronym / sponsor ID
- MORE / GCO 18-0878
- Conditions
- Opiate Use Disorder
- Keywords
- Mindfulness, Opiate Use Disorder, Drug Cue Reactivity, Inhibitory Control, Salience Attribution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- University of Utah, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 21 Jun 2020 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will be assessed before, immediately and three months after treatment. Results could point to factors that track and predict recovery with treatment, offering clinicians markers that can be used for enhancing precision medicine with the goal of reducing morbidity and mortality associated with opiate addiction.
Detailed description
Over the past 15 years, the US has been affected by increasing prescription and illicit opiate/opioid abuse, addiction, and overdose. Research into the enhancement of treatment options for individuals with opiate/opioid use disorder (iOUD) is clearly a priority. The development of neuroscience-informed behavioral therapies that could be used as adjuncts to improve effectiveness of medication-assisted interventions in iOUD is a national priority, a response to the opiate crisis. This study measures the neural correlates of cognitive function and reward processing as potentially contributing to and predictive of the impact of an 8-week group therapy on addiction outcome in iOUD. Using a pre-post randomized treatment design with a 3-months follow-up, this study will examine the impact of group therapy, as add-on to methadone maintenance, on neural functional and structural plasticity, and clinical outcomes (including daily ecological momentary assessments), in treatment-seeking iOUD (with primary use of heroin). Treatment-seeking iOUD will be randomized to 8-weeks of one of two of group therapies and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Healthy controls will be scanned at similar time intervals. Clinical outcome will be assessed during, immediately after and 3-months after therapy. Results may help identify individual variability in the brain regions/circuits that support reward processing, including cue reactivity, and inhibitory control and that could change with, and predict, response to treatment, ultimately contributing to precision medicine in OUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals with opiate use disorder (iOUD) will be randomized to one of two 8-weeks of group therapy and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Functional MRI (fMRI) scans during select tasks and at rest will assess responsiveness and connectivity of neural networks underlying impairments in Response Inhibition and Salience Attribution (iRISA). Structural MRI will assess the morphological integrity of the neural networks. A follow-up visit will take place 3 months after the second MRI scan. Healthy controls will be scanned at similar time intervals. Data collected from healthy control subjects will be used for comparative analyses.
| Arm | Type | Receives |
|---|---|---|
| Behavioral group therapy 1 | Experimental | Behavioral: Behavioral group therapy #18-weeks of group therapy |
| Behavioral group therapy 2 | Active comparator | Behavioral: Behavioral group therapy #28-weeks of group therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- The same as inclusion criteria 1-2 above; dependence on nicotine or caffeine is non-exclusionary.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral group therapy #1Participants will participate in an 8-weeks of group therapy that uses psychological principles including mindfulness training, and could help decrease cravings for heroin and increase general well-being. | Behavioural | Behavioral group therapy 1 |
| Behavioral group therapy #2Participants will participate in an 8-weeks of group therapy that uses psychological principles (but not including mindfulness training) and could help decrease craving for heroin and increase general well-being. | Behavioural | Behavioral group therapy 2 |
Primary outcome
Change in fMRI BOLD signal during tasks of reward
Time frame: baseline and 3 months after enrollment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during tasks of reward at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. The reward task uses symbols of gain/win and has been shown to elicit BOLD activations in the brain's reward network.
Change in fMRI BOLD signal for control reactivity
Time frame: baseline and 3 months enrollment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during control reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Change in fMRI BOLD signal for cue reactivity
Time frame: baseline and 3 months enrollment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during cue reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Change in fMRI BOLD signal acquired during resting-state functional connectivity
Time frame: baseline and 3 months after treatment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state functional connectivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. This method captures the synchronicity of low-frequency, spontaneous fluctuations in blood oxygen level-dependent signals that reflect fluctuations in neuronal activity between brain regions in the absence of external stimulation.
Change in MRI Voxel-Based Morphometry (VBM) measure
Time frame: baseline and 3 months after treatment
Change in MRI VBM measure for grey matter volume at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. Voxel Based Morphometry is a whole-brain, fully automated, unbiased, MRI analysis technique used to detect regionally specific differences in brain tissue composition using a voxel-wise comparison across participants.
Change in Urine drug test
Time frame: baseline and 3 months after treatment
Urine drug test at 3 months after treatment as compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Derived from this study: PubMed 42949709Huang Y, Ceceli AO, Kronberg G, Drury KR, King SG, McClain NE, Wong YY, Boros M, Butelman ER, Gaudreault PO, Parvaz MA, Alia-Klein N, Garland EL, Goldstein RZ. Prefrontal Cortical Changes With Mindfulness-Oriented Recovery Enhancement in Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Oct 28:e263388. doi: 10.1001/jamapsychiatry.2026.3388. Online ahead of print.
- Individual participant dataSharing planned: Yes. Relevant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Goldstein, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Nelly Alia-Klein, PhD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral group therapy #1 and Behavioral group therapy #2 in people with Opiate Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fMRI BOLD signal during tasks of reward (time frame: baseline and 3 months after enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04112186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.