Defining Neurobiological Links Between Substance Use and Mental Illness

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT05538910
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo Nicotine Patch — OTHER
    Comparator
  • Nicotine Patch — DRUG
    Study drug: 7.5 mg Nicotine Patch which will be administered in a double blind, randomized manner

Study Details

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.

Key Dates

Start date
Feb 2, 2023
Status verified
May 2026
Primary completion
Dec 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
620 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Arm 1: Placebo
    Placebo patch + Placebo Pill
  • Experimental: Arm 2: Nicotine Patch
    Nicotine Patch + Placebo Pill

Primary Outcome Measure

4.Nicotine effects and symptoms of MDD [ Time Frame: At each scan visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute on Drug AbuseBaltimoreMaryland21224
Kevin Noemer, M.A.
[email protected]
667-312-5225

Find similar trials in Baltimore, MD

By condition
DepressionSubstance use disorder
By specialty
PsychiatryMental healthBehavioral healthAddiction medicine
By research site
National Institute on Drug Abuse· Baltimore, MD

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