Targeting Drug Memories With Methylphenidate

Mount Sinai Health System

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Cocaine Use Disorder; Substance Use Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05978167

R21DA054281 (U.S. NIH Grant/Contract)

GCO 20-2707

Details and patient eligibility

About

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.

Full 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).

Enrollment: 51 patients

Sex: All

Ages: 26 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

Methylphenidate then Placebo

Experimental group

Description:

20 mg of methylphenidate then matching placebo pill.

Treatment:

Drug: Methylphenidate

Drug: Placebo

Behavioral: Memory reconsolidation

Placebo then Methylphenidate

Placebo Comparator group

Description:

Matching placebo pill then 20 mg of methylphenidate.

Treatment:

Drug: Methylphenidate

Drug: Placebo

Behavioral: Memory reconsolidation