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New treatment option for Nicotine Dependence
Official title Orexin s Role in the Neurobiology of Substance Use Disorder
ClinicalTrials.gov ID: NCT05630781
What this study is testing
What is Belsomra?
Belsomra is an investigational medicine, given as an once-daily, being studied as a potential treatment for nicotine dependence.
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
- Study Description: Despite the availability of pharmacotherapy for some substance use disorders, relapse vulnerability is still a significant issue. This suggests medications with alternative mechanisms of action should be explored to address this unmet need.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: All Participants
- Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes...
- Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent. Nicotine...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study: All Participants
- Participants cannot meet DSM-5 criteria for lifetime and/or current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective...
- Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current...
- Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana.
- Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as...
- Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: All Participants
- Participants will be volunteers between the ages of 18-60 at the time of enrollment in the study (both sexes). Justification: Many neural processes change with age, and these changes could introduce unwanted variability...
- Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent. Nicotine Dependence Arm -Participants must smoke/vape a minimum of 4 times per...
- An individual who meets any of the following criteria will be excluded from participation in this study: All Participants
- Participants cannot meet DSM-5 criteria for lifetime and/or current psychotic disorders such as bipolar disorder, schizophrenia, schizoaffective disorder.
- Participants cannot meet DSM-5 criteria for current substance use disorders other than nicotine and marijuana and cannot meet criteria for current moderate or severe alcohol use disorder.
- Participants cannot have positive illicit drug and alcohol screen on each study visit other than for nicotine or marijuana.
- Medications with the potential to depress CNS function will be assessed by the MAI, PI, or a physician's assistant and participants excluded as necessary.
- Participants cannot have a history of major head trauma resulting in cognitive impairment, seizure, or other neurological disorders.
- Participant cannot have any history of neurological disorders, including seizures, epilepsy, or cognitive impairment which may impact MRI metrics.
- Participants cannot be pregnant or breastfeeding. Justification: The impact of suvorexant on the developing fetus and infant.
- Individuals with severe hepatic impairment will be excluded
- Participants cannot be obese as determined by a Body Mass Index (BMI) of greater than 35.
- Participants cannot be using a strong CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant)
- Participants cannot have any past or present significant cardiac disorders or cerebrovascular conditions such as palpitations, tachycardia, use of the cardiac medication Digoxin, arrhythmias, acute coronary syndrome...
- Participants cannot have narcolepsy.
- Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls.
- Participants with Major Depressive Disorder who are using medication must be stable on medication for 3 months.
- people with suicidal ideation where outpatient treatment is determined unsafe.
- 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...
- Contraindication to MRI as determined by MRI Safety Screening form. Nicotine Dependent Arm
- Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease.
- Participants cannot meet DSM-5 criteria for moderate or severe ADHD. Control Arm
- May not have used any nicotine product more than once per week in the past year. Must have an expired carbon monoxide level of less than or equal to 5 ppm.
- Must not have a history of excessive substance use that may impact reward function, as evaluated by the PI, MAI, and/or designee.
- Current pharmacological treatment for opioid use disorder (i.e., use of methadone)
- May not have (or currently be treated/medicated for) any diagnoses/conditions contraindicated for use of methylphenidate.
- Participants may not have a diagnosis of moderate or severe ADHD (irrespective of medication use) or present with undiagnosed ADHD during screening.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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.