Actively Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Led by National Institute on Drug Abuse (NIDA) · Updated on 2026-05-11
620
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how nicotine affects brain function and symptoms of major depressive disorder (MDD), a condition where individuals are more likely to use nicotine and experience greater withdrawal and relapse. This study includes people aged 18 to 60, with and without MDD, who do not currently use nicotine. The goal is to understand the neurobiological links between nicotine use and mental illness, focusing on brain activity changes and related symptoms. Participants will attend two or three visits over one year, each involving two MRI brain scans spaced at least four days apart. Before each scan, they will receive either a nicotine patch or a placebo in a randomized, double-blind manner, meaning neither the participant nor the researchers know which treatment is given at each visit. During scans, participants will perform tasks like identifying colors or playing games, and researchers will monitor brain activity using resting and task-based fMRI. Throughout the study, participants will undergo urine and breath tests to check for recent alcohol, nicotine, or drug use, answer questions about their feelings and behaviors, and have blood samples taken after scans. Researchers will assess changes in brain function, symptoms of depression, and related biological markers. The total participation period spans up to one year, with detailed safety and health monitoring throughout.
CONDITIONS
Brief Title
Defining Neurobiological Links Between Substance Use and Mental Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Age between 18 and 60 years at the time of consent
- General good health
- Not pregnant or breastfeeding
- Breath alcohol value of 0 on all scanning visit days
- For MDD subjects: meet DSM-5 criteria for current major depressive disorder and have a baseline HAM-D score indicating depression
- For remitted MDD subjects: meet DSM-5 criteria for remitted major depressive disorder with no clinically relevant depression on HAM-D
- For control subjects without MDD: no current or lifetime major depressive disorder and no relevant medical, neurological, or psychiatric illness
- Daily nicotine users (study arm 2): use nicotine daily for at least six months and positive urine cotinine test
You will not qualify if you...
- Suicidal ideation deemed unsafe for outpatient treatment
- History or current diagnosis of psychotic disorders, bipolar disorder, or mood disorders with psychotic features
- Cognitive impairment or severe learning disabilities affecting data quality
- Heavy caffeine use exceeding 500 mg daily
- Regular nicotine use in the past year or daily use longer than one month (for non-nicotine users)
- Expired carbon monoxide level above 5 ppm or cotinine levels inconsistent with non-smoker status
- Recent moderate or severe substance use disorder (except caffeine)
- Current opioid use disorder treatment
- Illegal drug use other than marijuana, or marijuana use within 24 hours before scans
- Use of medications that may impact MRI measures prior to scan visits
- Significant cardiovascular, cerebrovascular, or respiratory conditions
- Body mass index below 18.5 kg/m²
- Contraindications to MRI or abnormal brain MRI findings
- Significant neurological illness or history of seizures
- Serious or unstable medical illness compromising safety
- Inability to speak English effectively for safety and data integrity reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of patch administration during scan visits
Participants receive either a nicotine patch or placebo patch in a double-blind, randomized manner while undergoing brain function assessments.
Multiple scan visits including resting-state and task-based fMRI assessments
Trial Site Locations
Total: 1 location
1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
N
NIDA IRP Screening Team
A
Amy C Janes, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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