MedPath

Targeting Drug Memories With Methylphenidate

Early Phase 1
Recruiting
Conditions
Substance Use Disorder
Cocaine Use Disorder
Interventions
Behavioral: Memory reconsolidation
Drug: Placebo
Registration Number
NCT05978167
Lead Sponsor
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.

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).

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Methylphenidate then PlaceboMethylphenidate20 mg of methylphenidate then matching placebo pill.
Methylphenidate then PlaceboMemory reconsolidation20 mg of methylphenidate then matching placebo pill.
Methylphenidate then PlaceboPlacebo20 mg of methylphenidate then matching placebo pill.
Placebo then MethylphenidateMethylphenidateMatching placebo pill then 20 mg of methylphenidate.
Placebo then MethylphenidateMemory reconsolidationMatching placebo pill then 20 mg of methylphenidate.
Placebo then MethylphenidatePlaceboMatching placebo pill then 20 mg of methylphenidate.
Primary Outcome Measures
NameTimeMethod
fMRI blood-oxygenation level dependent (BOLD) signalDay 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
NameTimeMethod
Skin Conductance Responses (SCR)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.

Craving24 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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

© Copyright 2025. All Rights Reserved by MedPath