Clinical trial NCT05978167: Targeting Drug Memories with Methylphenidate
Official title: Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction with Methylphenidate
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Substance Use Disorder
Cocaine Use Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 26
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: fMRI blood-oxygenation level dependent (BOLD) signal
timeFrame: Day 1
measure: fMRI blood-oxygenation level dependent (BOLD) signal
timeFrame: Day 7
Secondary outcomes:
measure: Skin Conductance Responses (SCR)
timeFrame: 24 hours after each neuroimaging session
measure: Craving
timeFrame: 24 hours after each neuroimaging session
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Rita Z Goldstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: