Developing new MRI methods to study brain function related to addiction
Development of Neuroimaging Methods to Assess the Neurobiology of Addiction
This study is testing new MRI techniques to see how the brains of healthy people work in relation to addiction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02535702 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance neuroimaging techniques, specifically using magnetic resonance imaging (MRI), to better understand brain function in healthy individuals. Researchers will conduct pilot studies with 128 healthy volunteers to optimize MRI pulse sequences and functional MRI (fMRI) tasks related to addiction. Participants will undergo medical screenings and MRI scans to assess brain activity and structure during various cognitive and emotional tasks. The goal is to improve the sensitivity and resolution of imaging methods to facilitate future research on addiction.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 years or older who can provide informed consent and are willing to abstain from drug use on testing days.
Not a fit: Patients with current psychiatric disorders, those with contraindications for MRI, or individuals who are claustrophobic may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnostic and treatment strategies for addiction by providing deeper insights into brain function.
How similar studies have performed: While this approach is innovative, similar studies using advanced MRI techniques have shown promise in understanding brain function, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:
1. Eighteen years or older.
2. Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent.
3. Willingness to abstain from drug use on scheduled testing days.
EXCLUSION CRITERIA
1. Positive urine pregnancy test in females.
2. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist.
3. Claustrophobia.
4. Body weight \>550 lbs, which is the weight limit of the MR scanner.
5. Current DSM-5 diagnosis of a psychiatric disorder (other than nicotine/caffeine use disorders) as determined by history and clinical exam including substance use disorder, alcoholism and alcohol dependence. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it was severe enough as to require hospitalization (any length), or chronic medication management (more than 4 weeks), or that could impact brain function at the time of the study. Subjects receiving psychotherapy may be included in the study.
6. Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 5 or more drinks in one occasion at least once a month.
7. Serious neurological disorder such as MS, Parkinson s Disease, ALS, sensory loss or peripheral neuropathy.
8. Currently taking any psychoactive drugs such as Celexa (TM), Prozac (TM), Wellbutrin (TM), Zoloft (TM), and/or stimulants other than caffeine such as Adderall (TM), Dexedrine (TM) and Ritalin (TM). Subjects taking PRN medications (e.g., sleep medications) may be included in the study.
9. Clinically significant laboratory or examination results.
10. Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).
11. \*Non-English speakers (must also be able to read and comprehend English).
* The intent of the research has no prospect of direct benefit to the subject. Therefore, we are excluding non-English speakers in this research study since our fMRI paradigms (particularly the Delay Discounting task) require that the subject be able to speak, read and comprehend English.
Subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for drugs/alcohol on initial screening. However, if they test positive on scheduled study procedure days involving MRI, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days that were the result of positive urine drug or BAL screens. If the drug/BAL tests is/are positive on the third rescheduled visit, the participant will be withdrawn from the study.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Dardo G Tomasi, Ph.D. — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study coordinator: Dardo G Tomasi, Ph.D.
- Email: dardo.tomasi@nih.gov
- Phone: (301) 496-1589
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.