Mindfulness therapy for heroin addiction
Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction
This study tests if two types of group therapy can help people struggling with heroin addiction by looking at changes in their brain activity before and after an 8-week program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04112186 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two types of group therapy on individuals with opioid use disorder, specifically focusing on heroin addiction. Participants will undergo neuroimaging to assess brain activity related to reward processing and inhibitory control before and after an 8-week therapy program. The study aims to identify neural correlates that may predict treatment outcomes and enhance precision medicine approaches in addiction recovery. Clinical outcomes will be evaluated during the treatment and at follow-up intervals to measure the effectiveness of the therapies.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-64 with a DSM-5 diagnosis of opioid use disorder, specifically those whose primary drug of choice is heroin and who are stabilized on methadone or other forms of medication-assisted treatment.
Not a fit: Patients with a history of schizophrenia, developmental disorders, or significant neurological or cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for individuals struggling with heroin addiction, potentially reducing relapse rates and enhancing recovery.
How similar studies have performed: Other studies have shown promise in using neuroscience-informed behavioral therapies for addiction treatment, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Rita Goldstein, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Kathryn R Drury
- Email: kathryn.drury@mssm.edu
- Phone: (770) 833-2128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.