BridgeMD
New treatment option for Major Depressive Disorder
Official title Defining Neurobiological Links Between Substance Use and Mental Illness
ClinicalTrials.gov ID: NCT05538910
What this study is testing
What is Nicotine Patch?
Nicotine Patch is an investigational medicine, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- To be eligible for this study, an individual must meet all the following criteria assessed under the currently approved NIDA IRP screening protocol...
- Able and willing to provide written informed consent.
- Both sexes and all ethnic origins, age between 18 and 60 at the time of consent. Justification: Many neural processes change with age, and these...
- Be generally healthy
- Absence of pregnancy and breastfeeding. Justification: study procedures and drugs used in the current protocol may complicate pregnancy or be...
You likely can't join if
- (STUDY ARM 1): An individual who meets any of the following criteria will be excluded from participation in this study:
- people 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...
- Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI...
- 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...
- May not have regularly used any nicotine product in the past year; must never have been daily nicotine users for more than 1 month.
See the full eligibility criteria
Who can join
- To be eligible for this study, an individual must meet all the following criteria assessed under the currently approved NIDA IRP screening protocol for the evaluation of potential research people (here referred to as...
- Able and willing to provide written informed consent.
- Both sexes and all ethnic origins, age between 18 and 60 at the time of consent. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI...
- Be generally healthy
- Absence of pregnancy and breastfeeding. Justification: study procedures and drugs used in the current protocol may complicate pregnancy or be transferred to nursing children. Assessment tool(s): Urine and/or serum...
- 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. MDD people:
- Meet DSM-5 diagnostic criteria for current MDD 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.
- Current stable serotonin modulating drug (e.g. SSRI/SNRI/serotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI Remitted MDD people:
- Meet DSM-5 diagnostic criteria for remitted MDD (full remission or partial remission or past depression) Clinical judgement will be used to interpret criteria.
- HAM-D score indicating no clinically relevant depression as evaluated by clinical staff.
- Current stable serotonin modulating drug (e.g. SSRI/SNRI/serotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI. Control people (without MDD):
- In addition to the absence of medical, neurological, and psychiatric illness listed above, control participants must not have current/lifetime MDD. Clinical judgement will be used to interpret criteria.
- HAM-D score indicating no clinically-relevant depression as evaluated by clinical staff. Daily Nicotine Users (Study Arm 2):
- Uses nicotine daily for at least six months
- Positive urine screen for cotinine
What rules you out
- (STUDY ARM 1): An individual who meets any of the following criteria will be excluded from participation in this study:
- people 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...
- 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...
- 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...
- May not have regularly used any nicotine product in the past year; must never have been daily nicotine users for more than 1 month.
- Must have an expired carbon monoxide level of less than or equal to 5 ppm and cotinine levels consistent with a non-smoker. Depending on the commercially available test used, a level equivalent to a non-smoker status...
- 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)
- Current use of illegal drugs other than marijuana as measured by urine drug screen Marijuana will not be allowed in the 24 hours prior to scanning based on self-report. Study day can be rescheduled to accommodate.
- Participants may not use anticholinergic drugs (i.e., scopolamine), dopamine enhancing drugs (i.e. methylphenidate), or other medications that may impact MRI measures (i.e. benzodiazepines) prior to any scanning visit...
- May not use drugs that directly enhance dopamine (i.e., methylphenidate) in the week prior to any scanning visit. Scanning visit timing can be adjusted to accommodate.
- Any past or present significant cardiovascular, cerebrovascular, or respiratory conditions, including arrhythmias, acute coronary syndrome, ischemic heart disease, or, uncontrolled hypertension
- Body mass index (BMI) lower than 18.5 kg/m\^2
- Contraindications to MRI as determined by MRI Safety Screening form and mock scanner trial (when available).
- Abnormal structural MRI, significant head trauma, current neurological illness including but not limited to frequent migraines, multiple sclerosis, movement disorder
- Lifetime history of significant seizure disorder
- Any other serious or unstable medical illness as defined by self-report, the evaluation of vital signs or other observation that in the view of the investigators would compromise the safety of an individual during...
- people that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that...
- people with active suicidal ideation where outpatient treatment is determined unsafe.
- Current psychiatric symptoms in which the ability to adhere to study protocol is determined to be impaired by clinical staff/MAI (e.g., difficulty understanding or answering questions, difficulty remaining still in the...
- 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...
- 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...
- Active severe substance use disorder in the past 6 months (other than caffeine and nicotine)
- Contraindications to MRI as determined by MRI Safety Screening form and mock scanner trial (when available).
- Abnormal structural MRI, significant head trauma, current neurological illness likely to impact fMRI signal or ability to comply with study requirements (e.g., staying still in scanner)
- Any serious or unstable medical illness as defined by self-report, the evaluation of vital signs or other observation that in the view of the investigators, would compromise the safety of an individual during...
- people that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.