Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction (NCT02535702) | Clinical Trial Compass
RecruitingNot Applicable
Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction
United States192 participantsStarted 2016-06-28
Plain-language summary
Background:
Abusing alcohol, drugs, and other substances can cause serious health problems. These substances also can affect brain function. Researchers want to learn more about brain function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio waves to take pictures of the brain.
Objective:
To develop new ways to use MRI to study the brain.
Eligibility:
Healthy people 18 years of age or older.
Design:
Participants will be screened with a medical history, physical exam, and blood and urine tests.
They will answer questions about their drug use and psychiatric history. They will be asked about family history of alcoholism or drug abuse.
Participants will answer questions to see if they can participate in MRI.
Participants will have MRI scans. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil may be placed over the head.
Each sub-study will include up to 3 different MRI visits. Participants can be in multiple sub-studies. But they can have only 1 MRI per week and 20 per year.
During MRI visits, participants may have urine collected. They may get another MRI questionnaire.
Participants may have a clinical MRI brain scan. This may show physical problems in the brain.
During some scans, participants may perform simple movement, memory, and thinking tasks.
Participants may be connected to a machine to monitor brain activity during the scan. Small metal electrodes will be placed on the scalp. A gel will be placed in the space between the electrodes and the scalp.
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Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Eighteen years or older.
✓. 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.
✓. Willingness to abstain from drug use on scheduled testing days.
Exclusion criteria
✕. Positive urine pregnancy test in females.
✕. 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.
✕. Claustrophobia.
✕. Body weight \>550 lbs, which is the weight limit of the MR scanner.
✕. 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.
What they're measuring
1
The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
Timeframe: end of study
2
The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
Timeframe: end of study
3
The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
Timeframe: end of study
Trial details
NCT IDNCT02535702
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
✕. 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.
✕. Serious neurological disorder such as MS, Parkinson s Disease, ALS, sensory loss or peripheral neuropathy.
✕. 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.