Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction (MORE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opiate Use Disorder
• Intervention / Treatment: Behavioral: Behavioral group therapy #1; Behavioral: Behavioral group therapy #2

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral group therapy 1; 8-weeks of group therapy	Behavioral: Behavioral group therapy #1; 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.
Active Comparator: Behavioral group therapy 2; 8-weeks of group therapy	Behavioral: Behavioral group therapy #2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	baseline and 3 months after treatment
Change in Urine drug test	Urine drug test at 3 months after treatment as compared to baseline	baseline and 3 months after treatment

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); University of Utah
• Investigators: Principal Investigator: Rita Goldstein, PhD, Icahn School Of Medicine At Mount Sinai; Study Director: Nelly Alia-Klein, PhD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2020
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Inhibitory Control; Opiate Use Disorder; Drug Cue Reactivity; Salience Attribution
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Heroin Dependence
• Other Study ID Numbers: GCO 18-0878; 1R01AT010627-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Relevant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.Any purpose.Proposals should be directed to rita.goldstein@mssm.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No