Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction With Methylphenidate
Overview
- Phase
- Early Phase 1
- Intervention
- Methylphenidate
- Conditions
- Substance Use Disorder
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- fMRI blood-oxygenation level dependent (BOLD) signal
- Status
- Active, Not Recruiting
- Last Updated
- 7 months ago
Overview
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).
Investigators
Rita Goldstein
Chief of Research
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
Intervention: Methylphenidate
Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
Intervention: Memory reconsolidation
Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
Intervention: Placebo
Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
Intervention: Methylphenidate
Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
Intervention: Memory reconsolidation
Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Skin Conductance Responses (SCR)(24 hours after each neuroimaging session)
- Craving(24 hours after each neuroimaging session)