Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Behavioral group therapy #1

Behavioral group therapy #2

Clinical Study ID

NCT04112186

GCO 18-0878

1R01AT010627-01

Ages 18-64
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 isnon-exclusionary.

Exclusion

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 medicalconditions, including metabolic, endocrinological,oncological or autoimmunediseases, and infectious diseases common in iOUD including Hepatitis B and C orHIV/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 Design

Behavioral group therapy #1

June 21, 2020

March 31, 2031

Study 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.

Connect with a study center

Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Site Not Available

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