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Procedure
TMS for Cocaine Use Disorder
N/A
Waitlist Available
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline(before itbs session),immediately after itbs session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline(before itbs session),immediately after itbs session
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 moreAwards & 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
944 Previous Clinical Trials
344,394 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,579 Previous Clinical Trials
3,316,850 Total Patients Enrolled
Heather Webber, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate-to-severe heart disease.I do not have any health conditions that could affect my study participation or safety.I am 18-21 and at risk for fainting due to nerve-heart issues.I am not pregnant or nursing.I have tested positive for cocaine use.I have had a stroke in the past.I am not on medications that are unsafe or increase seizure risk.I have had brain surgery in the past.I have had a brain lesion or condition causing increased pressure in my head.I have had a serious head injury with loss of consciousness.
Research Study Groups:
This trial has the following groups:- Group 1: dmPFC then dlPFC then sham iTBS
- Group 2: dlPFC then sham iTBS then dmPFC
- Group 3: sham iTBS then dlPFC then dmPFC
- Group 4: dlPFC then dmPFC then Sham iTBS
- Group 5: dmPFC then sham iTBS then dlPFC
- Group 6: shami iTBS then dmPFC then dl PFC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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