MedTrace Logo

Defining Neurobiological Links Between Substance Use and Mental Illness

NCT05538910 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2026-05-11

No results posted yet for this study

Summary

Background:

Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD.

Objective:

To understand how nicotine affects symptoms of depression and related brain function.

Eligibility:

People aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products.

Design:

Participants will have 2 or 3 study visits over 1 year.

Participants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs.

Before each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan.

For each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours.

Participants will answer questions about their thoughts, feelings, and behaviors before and after each scan.

They will have a blood test after each scan.

Conditions

Interventions

OTHER

Placebo Nicotine Patch

Comparator

DRUG

Nicotine Patch

Study drug: 7.5 mg Nicotine Patch which will be administered in a double blind, randomized manner

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Amy C Janes, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2027-12-30
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05538910 on ClinicalTrials.gov