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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112186
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : July 1, 2020
Sponsor:
Collaborators:
University of Utah
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Rita Goldstein, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Opiate Use Disorder Behavioral: Behavioral group therapy #1 Behavioral: Behavioral group therapy #2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112186


Contacts
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Contact: Pazia S Miller (212) 241-0965 pazia.miller@mssm.edu
Contact: Pias Malaker 212-241-2545 pias.malaker@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
University of Utah
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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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
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Responsible Party: Rita Goldstein, Professor of Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04112186    
Other Study ID Numbers: GCO 18-0878
1R01AT010627-01 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Relevant data collected during the trial, after deidentification.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rita Goldstein, Icahn School of Medicine at Mount Sinai:
Mindfulness
Opiate Use Disorder
Drug Cue Reactivity
Inhibitory Control
Salience Attribution
Additional relevant MeSH terms:
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Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders