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Neuropharmacological Imaging for Addiction

N/A

Recruiting

Led By Yihong Yang, Ph.D.

Research Sponsored by National Institute on Drug Abuse (NIDA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and non-pregnant female adults between the ages of 18-80

Be older than 18 years old

Must not have

Non-English speaking individuals

Subjects with suspected or confirmed active SARS-CoV-2 infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new MRI techniques to study the effects of addiction on the brain in order to develop more effective treatment strategies. Eligible participants must be between 18 and 55 years old, and may be smokers or nonsmokers, drug users or non-drug users. Each session will last approximately 2 hours and may include injections, specific tasks, or an experiment.

Who is the study for?

Adults aged 18-80, including smokers and non-smokers, drug users and non-users. Participants must be able to consent and understand English. Exclusions include pregnancy, metal implants that affect MRI safety, high seizure risk conditions, severe psychiatric or neurological disorders, major medical illnesses like heart disease or diabetes.

What is being tested?

The trial is developing new MRI techniques for addiction studies. It involves an initial screening with questionnaires followed by a series of MRI scans lasting about 2 hours each. Some scans may require tasks or study the brain's response to carbon dioxide.

What are the potential side effects?

MRI scanning is generally safe but can cause discomfort due to loud noises or claustrophobia during the scan. Non-Invasive Brain Stimulation (NIBS) could potentially lead to headaches, fainting episodes or seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult between 18 and 80 years old and if female, not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I currently have or am suspected to have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at each visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at each visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess effects of neuromodulation techniques, such as TMS and TRPMS, on brain activity and relevant MRI signals

To develop MRS techniques that are able to reliably measure metabolite and neurotransmitter concentrations in the brain at 3 Tesla, and to evaluate their feasibility and efficacy in drug addiction studies

To develop a simultaneous perfusion and BOLD imaging technique with improved functional contrasts and reduced susceptibility artifacts for determination of CMRO2 during brain activation

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: TRPMS Experiment 2Experimental Treatment2 Interventions

To evaluate cortical excitability changes caused by TRPMS measured with simultaneous TMS-fMRI. Participants will undergo a baseline TMS/fMRI session to get a measurement of baseline cortical excitability in the form of single-pulse TMS induced BOLD activation and determine motor hot-spot and RMT. We will then conduct an event-related single-pulse TMS/fMRI session with TMS stimulus at 120% RMT, 50 events with jittered inter-stimulus-interval (ISI) averaging 16s. Simultaneous EMG recording will be gathered from the corresponding hand muscle. Next we will use TRPMS to stimulate the left motor cortex over the hot-spot : 20-min application of TRPMS, 100ms duration, 0.2Hz (one stimulus every 5s), total 240 stimuli. Then we will evaluate the modulatory effect of the TRPMS stimulation via a second TMS/fMRI session with a similar procedure as the baseline session using the RMT determined at baseline. Total time for this experiment is about 5-6 hours.

Group II: TRPMS Experiment 1Experimental Treatment1 Intervention

To evaluate the prolonged effect of TPRMS on motor cortex excitability and help interpret and design subsequent experiments investigating the effect of TRPMS on BOLD signal. The experiment design consists of four groups, each group will include 10 participants (8 completers/group). For TRPMS stimulation sessions, our test conditions will be a 10 stimuli-session (approximately 2min), 50 stimuli-session (approximately 7min), 100 stimuli-session (approximately 14min), and 150 stimuli-session (20min) for each of the four groups, respectively. Therefore, the outcome will be measured with the spontaneous motor unit potentials (sMUPs) in the contralateral abductor pollicis brevis muscle (APB). After the stimulation session, we will measure sMUPs continuously for another 20min to observe the prolonged effect of the TRPMS stimulation and to compare these four conditions. The total approximate time required for this experiment is about 2-2.5 hours.

Group III: TMS-fMRI Experiment 1Experimental Treatment2 Interventions

To evaluate the relationship between BOLD activation and MEP and establish a BOLD activation marker of cortical excitability. Participants will start with a set of two short task-based EPI scans and anatomical scan. RMT will then be determined. Participants will undergo a single-pulse TMS-fMRI scan with stimulation intensities relative to the RMT over the motor cortex and/or the DLPFC. In total, six (6) intensities will be tested, 80% 100%, 105%, 110%, 115%, and 120% relative to the RMT. The fMRI design will be event-related. Each intensity (event type) will be presented 50 times. The order of the intensities will be randomized, and the inter-stimulus-interval (ISI) will range from 12s to 20s (centered at 16s plus random jittering in between, about 0.06Hz). The highest intensity of stimulation will be 120% RMT. EMG recordings in the corresponding hand muscle will be simultaneously acquired during the scan. Total approximate time required for this experiment is about 6-8 hours.

Group IV: MR Methodology Development and EvaluationExperimental Treatment2 Interventions

Methodology development and evaluation consists of pulse sequence development, testing, and parameter optimization. For each method we develop or evaluate, we may recruit up to 40 participants to come in for up to 4 visits each. Each participant will be scanned for up to 2 sessions per visit, not to exceed 4 total scan hours per visit.

0 / 3Eligibility criteria met