Health TrialsbyHealthPanel

Defining Neurobiological Links Between Substance Use and Mental Illness

ConditionsMajor Depressive DisorderSubstance Use DisorderNormal Physiology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Institute on Drug Abuse (NIDA)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able and willing to provide written informed consent.

Both sexes and all ethnic origins, age between 18 and 60 at the time of consent.

Absence of pregnancy and breastfeeding.

Have a Breath Alcohol Value of 0 on all study visit days involving scanning. Participant may be rescheduled if this value is greater than 0.

Disqualifiers

Subjects with suicidal ideation where outpatient treatment is determined unsafe.

Lifetime history or current diagnosis of any of the following psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features. The MAI and/or PI/LI will reserve the right to exclude based psychiatric history not explicitly described in this criterion

Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI will reserve the right to evaluate if a participant s history of educational placement is likely to represent a learning disability that could significantly impact the data gathered in this study based on the severity and type of learning disability. Justification: Cognitive impairment and learning disabilities may be associated with altered brain functioning in regions recruited during laboratory task performance.

Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). Participants will be asked to not deviate from their typical caffeine use on all scanning days.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo Nicotine Patch

    Other intervention

    Comparator

  • Nicotine Patch

    Drug

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

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Arm 1: PlaceboPlacebo comparator 1 intervention
Group B: Arm 2: Nicotine PatchExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

4.Nicotine effects and symptoms of MDD

Greater expression of MDD symptoms will related to a larger nicotine-induced impact within that domain.

Time frame
At each scan visit
2

3. Task and Resting State Brain

Relate static and temporal dynamic resting state brain function to nicotinic effects.

Time frame
At each scan visit
3

2.Task-fMRI

2\. Evaluate nicotine agonism on: 1) different phases of reward processing, 2) brain/behavioral measures of attentional bias using the classic and emotional Stroop task, and 1.3. 3) interoceptive awareness. 4) confidence on value-based decisions, determine the influence of sex in the context of points 1-3.

Time frame
At each scan visit
4

1.Resting-fMRI

1.Determine the impact of nicotine agonism on the brain s inherent function and organization at rest.

Time frame
At each scan visit

Secondary outcomes

1

Determine the relationship between blood-based biomarkers, such as inflammatory makers/metabolomics and nicotinic effects

Correlate levels of blood-based biomarkers with brain and behavioral measures and determine whether nicotine...

Time frame
Ongoing

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute on Drug Abuse (NIDA)

Lead sponsor

Source ClinicalTrials.gov
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