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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStony Brook University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age range 18 to 65 years old.

Capacity to consent (able to read, understand, and sign informed consent).

Age range 18 to 65 years old.

Capacity to consent (able to read, understand, and sign informed consent).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicotine transdermal patch

    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

    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.

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: ControlExperimental treatment 1 intervention
Group B: Major Depressive Disorder (MDD)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Hamilton Depression Rating Scale-17 (HAMD) score.

Description: Comparison of Hamilton Depression Rating Scale-17 score at pretreatment and post-treatment. Minimum score 0, maximum possible score 52, with remission defined as \<=7. The higher the score on the scale, the more severe the degree of depression.

Time frame
Before and after 8 days of treatment with nicotine.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Stony Brook University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator