Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction

NCT04112186 | Active Not Recruiting DMC

• 2 other identifiers: GCO 18-08781R01AT010627-01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Opiate Use Disorder

Keywords

Mindfulness; Opiate Use Disorder; Drug Cue Reactivity; Inhibitory Control; Salience Attribution

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Behavioral group therapy 1

EXPERIMENTAL

8-weeks of group therapy

Behavioral: Behavioral group therapy #1

Behavioral group therapy 2

ACTIVE COMPARATOR

8-weeks of group therapy

Behavioral: Behavioral group therapy #2

Interventions

Behavioral group therapy #1 BEHAVIORAL

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 1

Behavioral group therapy #2 BEHAVIORAL

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.

Behavioral group therapy 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of Utah: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Rita Goldstein, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Nelly Alia-Klein, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI and the majority of study personnel, including the study statistician, will be blinded to the treatment assignment until the database is unlocked. Assessors (of endpoints) will also be blinded to treatment assignment. That is, treatment allocation will only be known by selected research associates who are not involved in assessment or treatment. The selected research associates who are unblinded will handle randomization and preparation of any unblinded reports (if required); they will not have access to the data and no involvement in data monitoring or analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neuroscience

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: June 21, 2020
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)