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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at each visit
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am an adult between 18 and 80 years old and if female, not pregnant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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.

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Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,455 Previous Clinical Trials
2,596,214 Total Patients Enrolled
152 Trials studying Substance Abuse
706,392 Patients Enrolled for Substance Abuse
Yihong Yang, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
2 Previous Clinical Trials
225 Total Patients Enrolled

Media Library

Magnetom Prisma Fit 3T Scanner Clinical Trial Eligibility Overview. Trial Name: NCT01036581 — N/A
Substance Abuse Research Study Groups: TRPMS Experiment 2, MR Methodology Development and Evaluation, TMS-fMRI Experiment 1, TRPMS Experiment 1
Substance Abuse Clinical Trial 2023: Magnetom Prisma Fit 3T Scanner Highlights & Side Effects. Trial Name: NCT01036581 — N/A
Magnetom Prisma Fit 3T Scanner 2023 Treatment Timeline for Medical Study. Trial Name: NCT01036581 — N/A
Substance Abuse Patient Testimony for trial: Trial Name: NCT01036581 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently available to participants?

"As per the information found on clinicaltrials.gov, this research trial is in need of participants. The advertisement was initially posted on October 24th 2003 and the latest update came through on December 1st 2022."

Answered by AI

Is it possible to join this medical experiment?

"This clinical trial seeks to enrol 750 eligible individuals who are nicotine dependent. To be accepted, candidates must fit within the age range of 18-80 and meet additional prerequisites such as being a male or non-pregnant female between ages 18-55, generally healthy, and could come from any smoking, drug using/non drug using population."

Answered by AI

What is the current participant count for this research project?

"Confirmed. According to the information on clinicaltrials.gov, this medical trial is actively looking for suitable candidates and was first posted in October 24th 2003 with a most recent update occurring December 1st 2022. A total of 750 participants are required from two separate sites."

Answered by AI

Does the trial consider elderly candidates for enrollment?

"To be included in this medical trial, applicants must be between 18 and 80. For those below the age of consent there are 80 trials while individuals 65 or over have access to 325 different studies."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Georgetown University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am a meth addict that smokes cigs and cannabis and suffer from PTSD and bipolar 1 disorder but am currently not medicated regularly because of my drug use.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Georgetown University: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Phone Call
~165 spots leftby Dec 2029