What side effects are associated with this type of intervention?

Common treatments for cocaine dependence include pharmacological agents like topiramate and varenicline, as well as non-pharmacological approaches such as cognitive-behavioral therapy (CBT) and motivational enhancement therapy (MET). Topiramate can cause side effects such as impaired concentration, confusion, dizziness, anxiety, and paresthesias, leading to higher dropout rates. Varenicline may cause nausea, sleep disturbances, and neuropsychiatric symptoms. Non-pharmacological treatments like CBT and MET generally have fewer side effects but require significant patient engagement and motivation. While Low-Intensity Focused Ultrasound (LIFU) is still under investigation, its safety profile is not yet fully established, but it aims to modulate neural activity to reduce craving without the systemic side effects associated with pharmacological treatments.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of cocaine dependence. Research is ongoing to explore various treatment modalities, including neuromodulation techniques like Low-Intensity Focused Ultrasound (LIFU), which aims to modulate neural activity in the dorsal anterior insula to reduce craving. Other approaches under investigation include behavioral therapies and off-label use of medications approved for other conditions.

What other types of research exist?

Promising novel alternatives to LIFU for treating cocaine dependence include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing cravings and modifying neural activity; 2) Vagal Nerve Stimulation (VNS), which has been associated with reduced craving and relapse rates; 3) Behavioral interventions such as Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Relapse Prevention (MBRP), which focus on coping strategies and reducing cravings; and 4) Pharmacological treatments like Naltrexone and other emerging medications targeting neural pathways involved in addiction.

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Ultrasound Therapy

LIFU for Cocaine Use Disorder

N/A

Recruiting

Led By Nassima Ait-Daoud Tiouririne, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This trial will test if Low-Intensity Focused Ultrasound (LIFU) can reduce cravings for cocaine. 60 people with Cocaine Use Disorder (CUD) will be screened and 30 will be enrolled to see the effects of LIFU on craving.

Who is the study for?

This trial is for adults over 18 with a recent diagnosis of cocaine use disorder, who can lie still for imaging tests, have reliable transport, and stable housing. They must be able to avoid cocaine at certain times during the study and meet criteria for MRI scans.Check my eligibility

What is being tested?

The study is testing Low-Intensity Focused Ultrasound (LIFU) against a sham device to see if it reduces cravings in people with Cocaine Use Disorder by looking at brain activity and subjective craving levels after exposure to cocaine cues.See study design

What are the potential side effects?

Since this trial involves non-invasive ultrasound technology, side effects are expected to be minimal. However, participants may experience discomfort or mild headaches from lying down during the procedure or from the sham device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Decrease in average craving score by 25% for LIFU compared to sham

No evidence of neurological or other adverse events related to LIFU

Percent reduction in Bold Oxygen Level Dependent (BOLD)% signal change in response to cocaine cue exposure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-Intensity Focused Ultrasound (LIFU)Experimental Treatment1 Intervention

All subjects to receive LIFU and Sham in a randomized order.

Group II: Sham LIFUPlacebo Group1 Intervention

All subjects to receive LIFU and Sham in a randomized order.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low-Intensity Focused Ultrasound

2020

N/A

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cocaine Dependence, such as Low-Intensity Focused Ultrasound (LIFU), aim to modulate neural activity in brain regions like the dorsal anterior insula (dAI), which is associated with craving and addiction. By targeting these areas, LIFU can potentially reduce craving and improve self-control in response to cocaine cues. This neuromodulation approach is significant for patients as it offers a non-invasive method to alter brain function and reduce the likelihood of relapse. Other treatments, such as real-time fMRI neurofeedback, also focus on altering brain activity to decrease craving and enhance reward responsivity, providing a promising avenue for sustaining abstinence in cocaine-dependent individuals.

Neuromodulation of brain activation associated with addiction: A review of real-time fMRI neurofeedback studies.Effects of intra-accumbal or intra-prefrontal cortex microinjections of adenosine 2A receptor ligands on responses to cocaine reward and seeking in rats.Extinction of Cocaine Seeking Requires a Window of Infralimbic Pyramidal Neuron Activity after Unreinforced Lever Presses.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

759 Previous Clinical Trials

1,245,556 Total Patients Enrolled

Nassima Ait-Daoud Tiouririne, MDPrincipal InvestigatorUniversity of Virginia, Center for Leading Edge Addiction Research

1 Previous Clinical Trials

294 Total Patients Enrolled

Media Library

Low-Intensity Focused Ultrasound (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05857852 — N/A

Cocaine Dependence Research Study Groups: Low-Intensity Focused Ultrasound (LIFU), Sham LIFU

Cocaine Dependence Clinical Trial 2023: Low-Intensity Focused Ultrasound Highlights & Side Effects. Trial Name: NCT05857852 — N/A

Low-Intensity Focused Ultrasound (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05857852 — N/A

~11 spots leftby Mar 2025

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