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 range
18 Years – 64 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in fMRI BOLD signal during tasks of reward
Timeframe: baseline and 3 months after enrollment
2
Change in fMRI BOLD signal for control reactivity
Timeframe: baseline and 3 months enrollment
3
Change in fMRI BOLD signal for cue reactivity
Timeframe: baseline and 3 months enrollment
4
Change in fMRI BOLD signal acquired during resting-state functional connectivity
Timeframe: baseline and 3 months after treatment
5
Change in MRI Voxel-Based Morphometry (VBM) measure