Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Early Phase 1 study of Cocaine Use Disorder and Substance Use Disorder, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylphenidate
- BEHAVIORAL Memory reconsolidation
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2026-09-03 |
| Phase | Early Phase 1 |
What the registry record for NCT05978167 still lists
NCT05978167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 102-participant average among 26 other Cocaine Use Disorder trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cocaine Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05978167's enrollment target sits among peer trials
51 14th of 26 higher than 13 of 26 other Cocaine Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cocaine Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Cocaine and Pentoxifylline (BED IN 47)
RECRUITING · Early Phase 1
-
Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)
RECRUITING · Early Phase 1
-
Imaging CRF X NOP Interactions in CUD
RECRUITING · Early Phase 1
-
[C-11]NPA PET-amphetamine in Cocaine Use Disorders
RECRUITING · Early Phase 1
-
Safety Profile of Psilocybin for Cocaine Use Disorder
RECRUITING · Early Phase 1
-
[11C]NOP-1A and Cocaine Use Disorders
COMPLETED · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02701153 · 51 participants · NA
Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort
- NCT03663790 · 51 participants · NA
Effects of Gait Retraining on Lower Extremity Biomechanics
- NCT03874052 · 51 participants · Phase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- NCT04704661 · 51 participants · Phase 1
Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI