NCT04112186

Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opiate Use Disorder

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2020-06-21
• Primary completion: 2031-03-31
• Completion: 2031-03-31
• First posted: 2019-10-02
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States