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Targeting Drug Memories With Methylphenidate

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ClinicalTrials.gov Identifier: NCT05978167
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : June 7, 2024
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rita Goldstein, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorder Cocaine Use Disorder Drug: Methylphenidate Behavioral: Memory reconsolidation Drug: Placebo Early Phase 1

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction With Methylphenidate
Actual Study Start Date : July 5, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Memory

Arm Intervention/treatment
Experimental: Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
Drug: Methylphenidate
Oral administration of 20 mg Methylphenidate

Behavioral: Memory reconsolidation
Retrieval of drug-cue memories before extinction.

Drug: Placebo
Matching placebo pill

Placebo Comparator: Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
Drug: Methylphenidate
Oral administration of 20 mg Methylphenidate

Behavioral: Memory reconsolidation
Retrieval of drug-cue memories before extinction.

Drug: Placebo
Matching placebo pill




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   26 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05978167


Contacts
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Contact: Kathryn Drury, B.M. kathyrn.drury@mssm.edu
Contact: Yui Ying Wong, B.A. yuiying.wong@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Rita Z Goldstein, PhD Icahn School of Medicine at Mount Sinai
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Responsible Party: Rita Goldstein, Chief of Research, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT05978167    
Other Study ID Numbers: GCO 20-2707
R21DA054281 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: June 7, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents