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Procedure

TMS for Cocaine Use Disorder

N/A
Recruiting
Led By Heather Webber, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
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 baseline(before itbs session),immediately after itbs session
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the effects of electrical stimulation on brain activity related to rewards and attention in people with cocaine addiction.

Who is the study for?
This trial is for adults with cocaine use disorder who are not seeking treatment, have moderate to severe symptoms, and a recent positive urine test for cocaine. They must understand the consent form and provide contact details. Excluded are those with other substance disorders (except marijuana or nicotine), certain medical conditions, suicidal or homicidal risks, metal implants incompatible with TMS, unsafe medication doses, specific drug use within a week of enrollment or during the study.
What is being tested?
The study tests intermittent theta burst stimulation (iTBS) on two brain regions: left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC), compared to sham treatment. It aims to see how iTBS affects reward sensitivity and attention in individuals with cocaine use disorder.
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, seizures in rare cases or worsening of psychiatric symptoms. The side effects can vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline(before itbs session),immediately after itbs session
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline(before itbs session),immediately after itbs session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
Secondary study objectives
Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS)
Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task
Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: shami iTBS then dmPFC then dl PFCExperimental Treatment3 Interventions
Group II: sham iTBS then dlPFC then dmPFCExperimental Treatment3 Interventions
Group III: dmPFC then sham iTBS then dlPFCExperimental Treatment3 Interventions
Group IV: dmPFC then dlPFC then sham iTBSExperimental Treatment3 Interventions
Group V: dlPFC then sham iTBS then dmPFCExperimental Treatment3 Interventions
Group VI: dlPFC then dmPFC then Sham iTBSExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham iTBS
2008
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,785 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,601 Previous Clinical Trials
3,328,781 Total Patients Enrolled
Heather Webber, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
4 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Sham iTBS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05986578 — N/A
Cocaine Use Disorder Research Study Groups: dmPFC then dlPFC then sham iTBS, dlPFC then sham iTBS then dmPFC, sham iTBS then dlPFC then dmPFC, dlPFC then dmPFC then Sham iTBS, dmPFC then sham iTBS then dlPFC, shami iTBS then dmPFC then dl PFC
Cocaine Use Disorder Clinical Trial 2023: Sham iTBS Highlights & Side Effects. Trial Name: NCT05986578 — N/A
Sham iTBS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05986578 — N/A
~50 spots leftby Jun 2028
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