Targeting Drug Memories With Methylphenidate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2026-09-03

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Substance Use Disorder Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Methylphenidate then Placebo

20 mg of methylphenidate then matching placebo pill.

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

Oral administration of 20 mg Methylphenidate

Memory reconsolidation

Intervention Type BEHAVIORAL

Retrieval of drug-cue memories before extinction.

Placebo

Intervention Type DRUG

Matching placebo pill

Placebo then Methylphenidate

Matching placebo pill then 20 mg of methylphenidate.

Group Type PLACEBO_COMPARATOR

Methylphenidate

Intervention Type DRUG

Oral administration of 20 mg Methylphenidate

Memory reconsolidation

Intervention Type BEHAVIORAL

Retrieval of drug-cue memories before extinction.

Placebo

Intervention Type DRUG

Matching placebo pill

Interventions

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Methylphenidate

Oral administration of 20 mg Methylphenidate

Intervention Type DRUG

Memory reconsolidation

Retrieval of drug-cue memories before extinction.

Intervention Type BEHAVIORAL

Placebo

Matching placebo pill

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

26 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No