Lorazepam Effects on Neuroimaging Measures

Northwell Health

Status and phase: Withdrawn; Early Phase 1

Conditions: Neuroimaging; Lorazepam

Treatments: Drug: Placebo; Drug: Lorazepam 1Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04671836

20-0773

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18-40
4. In general good health as evidenced by medical history
5. Ability to take oral medication and be willing to adhere to the study medication regimen
6. For women of reproductive potential, negative pregnancy test and agreement to use a medically accepted birth control method.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnancy or lactation
2. Contraindications to MR imaging (i.e. pacemaker)
3. Known allergic reactions to components of the lorazepam
4. Current smoker or tobacco use
5. Concurrent use of any psychotropic medications, anticonvulsants, opioids or any other medication with effects on the CNS.
6. Acute narrow-angle glaucoma
7. Current or past history of a substance use disorder and/or a positive urine toxicology test.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Lorazepam first

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Lorazepam 1Mg Tablet

Placebo first

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Lorazepam 1Mg Tablet