Targeting Drug Memories With Methylphenidate

NCT05978167 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: GCO 20-2707R21DA054281
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use Disorder; Cocaine Use Disorder

Outcome Measures

Primary Outcomes (2)

• fMRI blood-oxygenation level dependent (BOLD) signal

  fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.

  Day 1

• fMRI blood-oxygenation level dependent (BOLD) signal

  fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.

  Day 7

Secondary Outcomes (2)

• Skin Conductance Responses (SCR)

  24 hours after each neuroimaging session

• Craving

  24 hours after each neuroimaging session

Study Arms (2)

Methylphenidate then Placebo

EXPERIMENTAL

20 mg of methylphenidate then matching placebo pill.

Drug: Methylphenidate; Behavioral: Memory reconsolidation; Drug: Placebo

Placebo then Methylphenidate

PLACEBO COMPARATOR

Matching placebo pill then 20 mg of methylphenidate.

Drug: Methylphenidate; Behavioral: Memory reconsolidation; Drug: Placebo

Interventions

Methylphenidate DRUG

Oral administration of 20 mg Methylphenidate

Methylphenidate then Placebo; Placebo then Methylphenidate

Memory reconsolidation BEHAVIORAL

Retrieval of drug-cue memories before extinction.

Methylphenidate then Placebo; Placebo then Methylphenidate

Placebo DRUG

Matching placebo pill

Methylphenidate then Placebo; Placebo then Methylphenidate

Eligibility Criteria

• Age: 26 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to understand and give informed consent
• Males and females, 18-65 years of age
• DSM-V diagnosis for CUD or otherwise problematic cocaine use as clinically determined

You may not qualify if:

• DSM-5 diagnosis for schizophrenia or developmental disorder (e.g., autism)
• Head trauma with loss of consciousness
• History of neurological disease of central origin including seizures
• Cardiovascular disease including high blood pressure and/or other medical conditions, including metabolic, endocrinological, oncological or autoimmune diseases, and infectious diseases including Hepatitis B and C or HIV/AIDS
• Metal implants or other MR contraindications

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rita Z Goldstein, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Research

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to rita.goldstein@mssm.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)