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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
904 Previous Clinical Trials
320,885 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,656 Total Patients Enrolled
Heather Webber, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
18 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to participants aged above 35 years?
"This medical trial is open to participants aged eighteen and above, but younger than sixty-five."
Answered by AI
Are there still opportunities to join this clinical experiment?
"Clinicaltrials.gov does not list this trial as actively recruiting patients; the details of which were initially posted on December 1st 2023 and last updated on August 3rd 2023. However, there are 26 other clinical trials accepting participants at present."
Answered by AI
Who meets the eligibility requirements to be part of this clinical trial?
"To be a suitable candidate for this trial, individuals should have cocaine use disorder and fall within the specified age range. This clinical study is looking to recruit 75 participants in total."
Answered by AI
What is the desired outcome of this clinical trial?
"The primary outcome being assessed over a baseline and post-treatment time frame is the variances in Late Positive Potential (LPP) amplitude, measured in microvolts, when exposed to visual stimuli on the Picture Viewing Task. Additionally, researchers will analyze shifts in pain as expressed through Visual Analogue Scale scores from 1-10; changes in cognitive capacity as judged by total Montreal Cognitive Assessment (MoCA) points ranging 0-30; and behavioural reward learning behaviour driven by Pavlovian Go/No-Go task performance."
Answered by AI
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