Active — Not RecruitingNot Applicable

Mindfulness-Oriented Recovery Enhancement (MORE) in Heroin Addiction

United States157 participantsStarted 2020-06-21

Plain-language 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.

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in fMRI BOLD signal during tasks of reward

Timeframe: baseline and 3 months after enrollment

Change in fMRI BOLD signal for control reactivity

Timeframe: baseline and 3 months enrollment

Change in fMRI BOLD signal for cue reactivity

Timeframe: baseline and 3 months enrollment

Change in fMRI BOLD signal acquired during resting-state functional connectivity

Timeframe: baseline and 3 months after treatment

Change in MRI Voxel-Based Morphometry (VBM) measure

Timeframe: baseline and 3 months after treatment

Change in Urine drug test

Timeframe: baseline and 3 months after treatment

Trial details

NCT IDNCT04112186

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03-31

View on ClinicalTrials.gov More Opiate Use Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in fMRI BOLD signal during tasks of reward

Timeframe: baseline and 3 months after enrollment

Change in fMRI BOLD signal for control reactivity

Timeframe: baseline and 3 months enrollment

Change in fMRI BOLD signal for cue reactivity

Timeframe: baseline and 3 months enrollment

Change in fMRI BOLD signal acquired during resting-state functional connectivity

Timeframe: baseline and 3 months after treatment

Change in MRI Voxel-Based Morphometry (VBM) measure

Timeframe: baseline and 3 months after treatment

Change in Urine drug test

Timeframe: baseline and 3 months after treatment