Clinical trial NCT04112186: Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction
Official title: Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opiate Use Disorder
Keywords: Mindfulness
Opiate Use Disorder
Drug Cue Reactivity
Inhibitory Control
Salience Attribution
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of Utah
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-10-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in fMRI BOLD signal during tasks of reward
timeFrame: baseline and 3 months after enrollment
measure: Change in fMRI BOLD signal for control reactivity
timeFrame: baseline and 3 months enrollment
measure: Change in fMRI BOLD signal for cue reactivity
timeFrame: baseline and 3 months enrollment
measure: Change in fMRI BOLD signal acquired during resting-state functional connectivity
timeFrame: baseline and 3 months after treatment
measure: Change in MRI Voxel-Based Morphometry (VBM) measure
timeFrame: baseline and 3 months after treatment
measure: Change in Urine drug test
timeFrame: baseline and 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Rita Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Nelly Alia-Klein, PhD
role: STUDY_DIRECTOR
References: