NCT04671836

Lorazepam Effects on Neuroimaging Measures

Lorazepam Effects on Neuroimaging Measures: A Pilot Study

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lorazepam
• Neuroimaging

Interventions

Type	Name	Description
DRUG	Lorazepam 1Mg Tablet	1 mg, white, five-sided (shield shape) tablet with a raised "A" on one side and "BPI" and "64" impressed on scored reverse side. NDC 0187-0064-01 - Bottles of 100 tablets; NDC 0187-0064-50 - Bottles of 500 tablets; NDC 0187-0064-10 - Bottles of 1000 tablets. The pharmacy at the Zucker Hillside Hospital will encapsulate both lorazepam 1 mg and placebo pills to make them look the same. On the day of the scan, the research coordinator or the PI will pick up the blinded study medication (lorazepam or placebo) and will administer it to the participant. One hour later, the participant will be placed in the scanner to complete the MRI.
DRUG	Placebo	Placebo will be purchased and encapsulated by the pharmacy at the Zucker Hillside Hospital.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-12-17
• Last updated: 2022-05-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study