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Corticosteroid

Methylphenidate for Cocaine Use Disorder

Phase < 1
Recruiting
Led By Rita Z Goldstein, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after each neuroimaging session
Awards & highlights

Study Summary

This trial seeks to identify methods to reduce drug memories and cravings in people with cocaine use disorder through MRI, interviews, and behavioral tasks.

Who is the study for?
This trial is for men and women aged 26-50 with a diagnosis of cocaine use disorder (CUD) who can give informed consent. It's not suitable for those with metal implants, schizophrenia, developmental disorders like autism, cardiovascular diseases including high blood pressure, other serious medical conditions or infectious diseases such as Hepatitis B/C or HIV/AIDS.Check my eligibility
What is being tested?
The study tests if Methylphenidate affects the way people with CUD remember drug-related cues. Participants will take either Methylphenidate or a placebo in a controlled environment while undergoing an MRI scan to observe brain activity and skin conductance responses that indicate memory modification.See study design
What are the potential side effects?
Potential side effects of Methylphenidate include nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting or increased heart rate. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after each neuroimaging session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after each neuroimaging session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
fMRI blood-oxygenation level dependent (BOLD) signal
Secondary outcome measures
Craving
Skin Conductance Responses (SCR)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Methylphenidate then PlaceboExperimental Treatment3 Interventions
20 mg of methylphenidate then matching placebo pill.
Group II: Placebo then MethylphenidatePlacebo Group3 Interventions
Matching placebo pill then 20 mg of methylphenidate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
2014
Completed Phase 4
~431850
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,576 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,681 Total Patients Enrolled
Rita Z Goldstein, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Methylphenidate (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05978167 — Phase < 1
Substance Use Disorder Research Study Groups: Methylphenidate then Placebo, Placebo then Methylphenidate
Substance Use Disorder Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT05978167 — Phase < 1
Methylphenidate (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05978167 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots available for participants in this trial?

"As documented on clinicaltrials.gov, this medical study is currently endeavouring to find participants. The trial was launched on July 5th 2023 and the most recent amendment was made on July 28th 2023."

Answered by AI

To what patient population does this clinical trial apply?

"This clinical trial seeks to recruit 50 participants with substance use disorder aged between 26 and 50. To be accepted, these criteria must be met."

Answered by AI

Does this research endeavor accept elderly participants?

"This clinical trial has a minimum age requirement of 26 and a maximum age cap of 50, as per the specified eligibility requirements."

Answered by AI

How many participants have been recruited for this experiment?

"Indeed, according to the clinicaltrials.gov database, this scientific trial is currently seeking volunteers. Initially posted on July 5th 2023 and recently updated on 28th of the same month, only 50 participants are needed from a single medical site."

Answered by AI
~15 spots leftby Aug 2024