Lorazepam Effects on Neuroimaging Measures
- Conditions
- LorazepamNeuroimaging
- Interventions
- Drug: Placebo
- Registration Number
- NCT04671836
- Lead Sponsor
- Northwell Health
- Brief Summary
This within-subject, double blind, randomized controlled study will investigate the effects of a widely used benzodiazepine (BZD), lorazepam, on various neuroimaging measures. The investigators will be assessing the relationship of lorazepam to resting state functional connectivity and other neuroimaging measures. Specifically, the investigators will be using a pre-identified metric, the striatal connectivity index (SCI), (Sarpal et al. 2015, 2016), a prognostic biomarker of treatment response assessing the connectivity between regions of the striatum and the cortex. The investigators hypothesize that lorazepam administration will be associated with greater SCI values compared with placebo administration; consistent with previous work suggesting short-acting benzodiazepines increase functional connectivity across brain networks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-40
- In general good health as evidenced by medical history
- Ability to take oral medication and be willing to adhere to the study medication regimen
- For women of reproductive potential, negative pregnancy test and agreement to use a medically accepted birth control method.
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Contraindications to MR imaging (i.e. pacemaker)
- Known allergic reactions to components of the lorazepam
- Current smoker or tobacco use
- Concurrent use of any psychotropic medications, anticonvulsants, opioids or any other medication with effects on the CNS.
- Acute narrow-angle glaucoma
- Current or past history of a substance use disorder and/or a positive urine toxicology test.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lorazepam first Lorazepam 1Mg Tablet This arm comprises of participants who were randomized to receive lorazepam 1 mg prior to the first MRI scan and then placebo on the second MRI scan a week later. Placebo first Lorazepam 1Mg Tablet This arm comprises of participants who were randomized to receive placebo prior to the first MRI scan and then lorazepam 1 mg orally prior to the second MRI scan a week later. Lorazepam first Placebo This arm comprises of participants who were randomized to receive lorazepam 1 mg prior to the first MRI scan and then placebo on the second MRI scan a week later. Placebo first Placebo This arm comprises of participants who were randomized to receive placebo prior to the first MRI scan and then lorazepam 1 mg orally prior to the second MRI scan a week later.
- Primary Outcome Measures
Name Time Method To understand the impact of lorazepam on functional connectivity measures collected using resting state functional magnetic imaging (rs-fMRI). 2 weeks SCI, a parameter that captures the connectivity between the stratum and the cortex, is a primary candidate for a prognostic biomarker that may guide individual treatment. Exploratory functional connectivity analyses between other brain regions will be conducted as well.
- Secondary Outcome Measures
Name Time Method The goal is to study the impact of lorazepam on glutamate, glutamine and GABA in the striatum. 2 weeks Metabolite concentrations measured in parts per million (ppm) for Glutamate, glutamine and GABA; obtained with Magnetic Resonance Spectroscopy (MRS).
Trial Locations
- Locations (1)
The Zucker Hillside Hospital
🇺🇸Glen Oaks, New York, United States