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NCT Number: NCT05978167

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Substance Use Disorder Chemically-Induced Disorders Cocaine Use Disorder Mental Disorders Substance-Related Disorders

Age range

26 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

Cue-exposure therapy has not proven efficacious in reducing relapse in drug addiction, illuminating the need for alternative strategies. Here researchers will test the neural correlates of two strategies, encompassing behavioral and pharmacological approaches, aimed to interfere with the return of drug memories in individuals with cocaine use disorders. Results may pave the way towards enhancing the efficacy of cue-exposure therapy in reducing cue-induced craving and relapse in drug addiction (generalizable across drugs of abuse/behavioral addictions).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Methylphenidate

Drug

Oral administration of 20 mg Methylphenidate

Memory reconsolidation

Behavioral

Retrieval of drug-cue memories before extinction.

Placebo

Drug

Matching placebo pill

Primary outcomes

  1. fMRI blood-oxygenation level dependent (BOLD) signal

    Time frame: Day 1

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

  2. fMRI blood-oxygenation level dependent (BOLD) signal

    Time frame: Day 7

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

Secondary outcomes

  1. Skin Conductance Responses (SCR)

    Time frame: 24 hours after each neuroimaging session

    Measure of changes to skin conductance responses in response to retrieval of drug-cue memory. The conductance is measured by placing two electrodes on the fingers and passing a small, 0.5 V electric charge between the two points. An increase in the skin conductance response (SCR) reflects heightened arousal in response to the drug-cue memory, changes in which are monitored following exposure to the drug cues.

  2. Craving

    Time frame: 24 hours after each neuroimaging session

    Measure of changes to craving in response to retrieval of drug-cue memory. Self-reported cue-induced craving in response to drug cues will be assessed.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction With Methylphenidate

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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