Lorazepam Effects on Neuroimaging Measures

NCT ID: NCT04671836

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Lorazepam; Neuroimaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Lorazepam first

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.

Group Type: EXPERIMENTAL

Lorazepam 1Mg Tablet

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Placebo will be purchased and encapsulated by the pharmacy at the Zucker Hillside Hospital.

Placebo first

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.

Group Type: PLACEBO_COMPARATOR

Lorazepam 1Mg Tablet

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

Placebo will be purchased and encapsulated by the pharmacy at the Zucker Hillside Hospital.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo will be purchased and encapsulated by the pharmacy at the Zucker Hillside Hospital.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Juan Gallego Angel

Assistant Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan A Gallego, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

The Zucker Hillside Hospital

Glen Oaks, New York, United States

Countries

United States

References

Sarpal DK, Argyelan M, Robinson DG, Szeszko PR, Karlsgodt KH, John M, Weissman N, Gallego JA, Kane JM, Lencz T, Malhotra AK. Baseline Striatal Functional Connectivity as a Predictor of Response to Antipsychotic Drug Treatment. Am J Psychiatry. 2016 Jan;173(1):69-77. doi: 10.1176/appi.ajp.2015.14121571. Epub 2015 Aug 28.

Reference Type: RESULT

PMID: 26315980 (View on PubMed)

Sarpal DK, Robinson DG, Lencz T, Argyelan M, Ikuta T, Karlsgodt K, Gallego JA, Kane JM, Szeszko PR, Malhotra AK. Antipsychotic treatment and functional connectivity of the striatum in first-episode schizophrenia. JAMA Psychiatry. 2015 Jan;72(1):5-13. doi: 10.1001/jamapsychiatry.2014.1734.

Reference Type: RESULT

PMID: 25372846 (View on PubMed)

Other Identifiers

20-0773

Identifier Type: -

Identifier Source: org_study_id