Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use

Cocaine Dependence Clinical Trial

Official title: Neuroplasticity Following Theta-Burst Stimulation in Cocaine Use Disorder

Status Recruiting

Clinical Trial Summary

Background:

More effective treatments for people with cocaine use disorder are needed. Researchers want to understand the parts of the brain involved in the disorder. Transcranial magnetic stimulation (TMS) stimulates parts of the brain. A form of TMS called intermittent theta-burst stimulation (iTBS) may help reduce cocaine use. Researchers want to learn how the brain might change with treatment.

Objectives:

To test if iTBS can reduce cocaine use. Also, to learn how cocaine changes the heart and the brain.

Eligibility:

Healthy, right-handed adults ages 18-60 who do or do not have cocaine use disorder.

Design:

Participants will be screened with:

• Questionnaires

• Medical history

• Physical exam

• Blood and urine tests

• Alcohol breath tests

In the pilot study, 10 participants with cocaine use disorder will have 10 treatment days over 2 weeks. Half will be inpatient and half will be outpatient. They will have 2 follow-up visits. Treatment includes:

• iTBS: A coil is placed on the head. A brief electrical current passes through the coil. They view cocaine-related images during each session. Sessions are videotaped.

• Repeat of screening tests

• In the main study, participants will be randomly assigned to have either real or fake iTBS.

• Participants with cocaine use disorder will join an incentive program to quit.

• Participants will have 39 visits over 6 months. These include:

• Repeat of screening tests

• MRIs at 5 visits: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner.

• iTBS at 10 visits (5 days a week for 2 weeks)

Participants will be contacted throughout the study to discuss iTBS treatment and drug use.

Clinical Trial Description

Objectives: Illicit drug use affects tens of millions of Americans and costs nearly $200 billion annually in health care costs and lost productivity. Cocaine dependence accounts for 25% of reported lifetime drug dependence though few successfully abstain with treatment. For efforts toward positive long-term outcomes, it is imperative to identify risk factors of poor outcomes, specialized treatments, neural mechanisms that change with treatment, and predictive measures of treatment outcomes. Substance abusers are known to have dysregulation in cue reactivity, reward processing, executive control, and intrinsic network connectivity. Non-invasive brain stimulation (NIBS) has proven effective at reducing drug craving in nicotine, alcohol, and cocaine users. Here, intermittent theta-burst stimulation (iTBS), a type of NIBS, delivered to left dorsolateral prefrontal cortex (dlPFC) is implemented to modulate substance abuse related circuit dysregulations and assess the relationship of iTBS-induced changes in circuitry to ongoing cocaine use. ;

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine Use Disorder
• Cocaine-Related Disorders

• NCT number: NCT02927236
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NIDA IRP Screening Team
• Phone: (800) 535-8254
• Email: researchstudies@nida.nih.gov
• Status: Recruiting
• Phase: Phase 4
• Start date: February 13, 2017
• Completion date: December 31, 2024