This study is currently recruiting participants.
Number
001066-DA
Sponsoring Institute
National Institute on Drug Abuse (NIDA)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 60 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Non-English Speaking;Children
Keywords
Orexin Antagonish; fMRI; Substance Use Disorder; Nicotine Dependence
Recruitment Keyword(s)
None
Condition(s)
Nicotine Dependence
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Placebo Drug: Belsomra
Supporting Site
National Institute on Drug Abuse
Tobacco use leads to about 480,000 deaths each year in the US. Several treatment aids can help people stop smoking, but as many as 75% of those who quit will start again within a year. Researchers are looking for new ways to help people stop smoking.
Objective:
To find out if a drug called suvorexant can reduce the desire to smoke or vape among people who are dependent on nicotine.
Eligibility:
Healthy adults aged 18-60 who have smoked or vaped daily for at least the past year.
Design:
Participants will have 5 or 6 visits about a week apart. They will have a brief physical exam at each visit. They will provide urine and have their breath tested. They will fill out questionnaires about their thoughts, feelings, and behaviors.
Participants will have a total of 5 magnetic resonance imaging (MRI) scans. They will lie still on a table that slides into a tube. They will perform thinking tasks during the scans; they will play games on a computer or look at pictures.
At 2 visits, participants will take a pill by mouth prior to the MRI scan. They may receive either the study drug or a placebo. The placebo looks just like the study drug but contains no active ingredients. They will not know which type of pill they are taking.
For 2 weeks during the study, participants will take their pills once a day at home.
Throughout the study, participants will wear a watch-like device to record their sleep habits. They will complete a daily diary to record their smoking, vaping, mood, sleep, cravings, and side effects.
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INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: -Participants will be volunteers between the ages of 18-60 (all genders). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. -Participants must be a daily smoker/vaper with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng/ml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts). -Female participants must have a negative pregnancy test on all study days. -Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: -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 CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant) -Participants cannot have a current cardiac disorder such as palpitations, tachycardia and/or use of the cardiac medication Digoxin -Participants cannot have narcolepsy -Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls -Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease -Participants with Major Depressive Disorder must be stable on medication for 3 months -Subjects with suicidal ideation where outpatient treatment is determined unsafe -Subjects 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 we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non- English-speaking participants -Contraindication to MRI as determined by MRI Safety Screening form
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-Participants will be volunteers between the ages of 18-60 (all genders). Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals.
-Participants must be a daily smoker/vaper with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng/ml) and have been smoking or vaping consistently for at least the past year (excluding quit attempts).
-Female participants must have a negative pregnancy test on all study days.
-Able and willing to provide written informed consent, which includes agreement to all Lifestyle Considerations at the time of study consent.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
-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 CYP3A inhibitor/inducer (metabolism by CYP3A is the major elimination pathway for suvorexant)
-Participants cannot have a current cardiac disorder such as palpitations, tachycardia and/or use of the cardiac medication Digoxin
-Participants cannot have narcolepsy
-Participants cannot self-report complex sleep behaviors such as sleep driving, preparing and eating food or making phone calls
-Participants cannot self-report compromised respiratory function such as severe obstructive sleep apnea or severe chronic obstructive pulmonary disease
-Participants with Major Depressive Disorder must be stable on medication for 3 months
-Subjects with suicidal ideation where outpatient treatment is determined unsafe
-Subjects 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 we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non- English-speaking participants
-Contraindication to MRI as determined by MRI Safety Screening form
Principal Investigator
Referral Contact
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