Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction

Opiate Use Disorder Clinical Trial

— MORE  

Official title:

Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04112186
• Other study ID #: GCO 18-0878
• Secondary ID: 1R01AT010627-01
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Natalie McClain, BA
• Phone: (502) 303-4101
• Email: natalie.mcclain[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heroin Dependence
• Opiate Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Center for Complementary and Integrative Health (NCCIH), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Urine drug test	Urine drug test at 3 months after treatment as compared to baseline	baseline and 3 months after treatment