PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.

NCT ID: NCT07095205

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2029-09-30

Brief Summary

In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

This arm consists of non-depressed participants. These participants will receive one PET scan utilizing tracer \[18F\] VAT to measure cholinergic terminal density.

Group Type: EXPERIMENTAL

PET Scan with [18F] VAT

Intervention Type: DRUG

All participants will undergo a PET scan at Baseline using tracer \[18F\] VAT. Participants with MDD will undergo a second post-treatment PET scan using tracer \[18F\] VAT.

Major Depressive Disorder (MDD)

This arm consists of participants diagnosed with Major Depressive Disorder. Participants in the MDD arm will receive interventional treatment for 8 days with transdermal nicotine patches. Participants in the MDD arm will also receive two PET scans with \[18F\]VAT tracer: one at baseline and one post-treatment.

Group Type: EXPERIMENTAL

Nicotine transdermal patch

Intervention Type: DRUG

The participants with MDD will receive Nicorette NicoDerm CQ nicotine transdermal patches for 8 days (7 mg/day for days 1-2, 14 mg/day for days 3-4, and 21 mg/day for days 5-8).

PET Scan with [18F] VAT

Intervention Type: DRUG

All participants will undergo a PET scan at Baseline using tracer \[18F\] VAT. Participants with MDD will undergo a second post-treatment PET scan using tracer \[18F\] VAT.

Interventions

Nicotine transdermal patch

The participants with MDD will receive Nicorette NicoDerm CQ nicotine transdermal patches for 8 days (7 mg/day for days 1-2, 14 mg/day for days 3-4, and 21 mg/day for days 5-8).

Intervention Type: DRUG

PET Scan with [18F] VAT

All participants will undergo a PET scan at Baseline using tracer \[18F\] VAT. Participants with MDD will undergo a second post-treatment PET scan using tracer \[18F\] VAT.

Intervention Type: DRUG

Other Intervention Names

Nicorette NicoDerm CQ; Nicotine patch

Eligibility Criteria

Inclusion Criteria

For Non-Depressed Participants:

• Age range 18 to 65 years old.
• Capacity to consent (able to read, understand, and sign informed consent).

For Participants with MDD

• Age range 18 to 65 years old.
• Capacity to consent (able to read, understand, and sign informed consent).
• Major Depressive Disorder (MDD) as primary diagnosis and currently in a major depressive episode
• Score of at least 29 on the Montgomery-Asberg Depression Rating Scale (MADRS).

Exclusion Criteria

For Non-Depressed Participants:

• Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year [except for occasional users, who cannot use nicotine products in the week before the scan].
• Need for use of medication during the study that will affect cholinergic levels.
• Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
• Significant active physical illness or neurological deficit that may affect brain function or imaging.
• Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
• Current or lifetime history of a major psychiatric diagnosis.
• Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
• Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
• Blood donation within 8 weeks of the [18F]VAT scan.

For Participants with MDD

• Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year [except for occasional users, who cannot use nicotine products in the week before the scan].
• Currently on effective antidepressant medications or need for use of medications that target the cholinergic system.
• Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
• Significant active physical illness or neurological deficit that may affect the brain function or imaging.
• Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
• Current or lifetime major psychiatric diagnosis other than MDD.
• Life-time history of psychosis or current psychosis.
• Significant risk for suicide.
• Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
• Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
• Blood donation within 8 weeks of the [18F]VAT scan.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Ramin Parsey

Professor of Psychiatry, Director of PET Strategy (M.D., Ph.D.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramin Parsey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University: Dept of Psychiatry

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julianna Lizzul

Role: CONTACT

julianna.lizzul@stonybrookmedicine.edu

631-638-0291

Facility Contacts

Julianna Lizzul

Role: primary

julianna.lizzul@stonybrookmedicine.edu

631-638-0291

Ramin Parsey, M.D., Ph.D.

Role: backup

Other Identifiers

1R21MH137546-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB2023-00490

Identifier Type: -

Identifier Source: org_study_id