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NCT05978167 · ClinicalTrials.gov registry record · Early Phase 1

Targeting Drug Memories With Methylphenidate

A Early Phase 1 study of Cocaine Use Disorder and Substance Use Disorder, sponsored by Icahn School of Medicine at Mount Sinai.

Active
Registry status
Early Phase 1
Development phase
51
Enrollment target
1
Study location

NCT05978167 is a Early Phase 1 study of Cocaine Use Disorder and Substance Use Disorder that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 51 participants, below the 102-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05978167, a Early Phase 1 study of Cocaine Use Disorder and Substance Use Disorder, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
51 participants
Enrollment target
1
Study location

Study Summary

This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting diminished expression of drug-related memories in human drug addiction. In this fMRI study with a within-subjects placebo-controlled double-blind cross-over design, oral methylphenidate (20 mg) or placebo will be administered to individuals with cocaine use disorders (CUD) to peak during the retrieval of a drug-cue memory before extinction; in addition to fMRI activations, skin conductance responses (SCR, acquired simultaneously) will serve as the psychophysiological indicators of memory modification. Assessments of interference with the return of drug-cue memories via SCR and craving will be conducted the day following MRI. This pharmocologically-enhanced behavioral approach to decreasing drug memories and craving in iCUD could ultimately be used to develop effective cue-exposure therapies for drug addiction. Procedures include MRI, blood draw, questionnaires and interviews, skin conductance response measures, and behavioral tasks.

Interventions

  • DRUG Placebo
  • DRUG Methylphenidate
  • BEHAVIORAL Memory reconsolidation

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2023-07-05
Est. Completion 2026-09-03
Phase Early Phase 1

What the Registry Record Tells You About NCT05978167

The ClinicalTrials.gov registry entry for NCT05978167 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 102-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (50% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cocaine Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05978167 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05978167 about?

NCT05978167 is a clinical study titled "Targeting Drug Memories With Methylphenidate". This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting diminished expression of drug-related memories in human drug addiction. In this fMRI study with a within-subjects placebo-controlled double-blind cross-over design, oral methylphenidate (20 mg) or placebo wi...

What is the current status of trial NCT05978167?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 51 participants. The study started on 2023-07-05. Estimated completion is 2026-09-03.

What conditions does trial NCT05978167 study?

This clinical trial studies the following conditions: Cocaine Use Disorder, Substance Use Disorder.

What interventions are being tested in trial NCT05978167?

The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG), Memory reconsolidation (BEHAVIORAL).

Who is sponsoring clinical trial NCT05978167?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05978167 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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