RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Nicotine Patch for Major Depressive Disorder

Background: Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (major depression) are twice as likely to use nicotine compared to the general population.

Official registry: https://clinicaltrials.gov/study/NCT05538910 · National Institute on Drug Abuse (NIDA) · enrollment listed as 620

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Placebo Nicotine Patch, or Nicotine Patch. The registry lists allocation as randomized. Background: Nicotine dependence leads to about 480,000 deaths every year in the United States.

They plan to enroll about 620 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Defining Neurobiological Links Between Substance Use and Mental Illness

Interventions: Placebo Nicotine Patch, Nicotine Patch

Primary outcome (registry wording): 4.Nicotine effects and symptoms of MDD

Who it is for (from inclusion criteria)

Ages 18 Years to 60 Years
screening protocol will capture information above and beyond what is necessary to determine eligibility for this protocol but allows the Investigators to assess the eligibility criteria for this protocol
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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
Meet DSM-5 diagnostic criteria for current major depression at screening Clinical judgement will be used to interpret criteria
Have a baseline (Hamilton Depression) HAM-D score indicative of current depression as evaluated by clinical staff

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
Subjects with suicidal ideation where outpatient treatment is determined unsafe
a. Within the control group, current use of antidepressants for psychiatric reasons will be exclusionary. The MAI reserves the right to evaluate use of antidepressants for non-psychiatric uses as appropriate for participation in the study
Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). you would be asked to not deviate from their typical caffeine use on all scanning days
May not have used any nicotine product weekly or more frequently than weekly in the past year; must never have been daily nicotine users for more than 1 month
History of moderate or severe substance use disorder in the past 6 months (other than caffeine)
Current pharmacological treatment for opioid use disorder (i.e., use of methadone)

Public study contact (from the registry)

NIDA IRP Screening Team

(800) 535-8254

researchstudies@nida.nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institute on Drug Abuse — Baltimore, Maryland (recruiting)

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FAQ about this NCT record

Is NCT05538910 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05538910?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05538910?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary