An interventional study of Belsomra and Placebo in Nicotine Dependence, sponsored by National Institute on Drug Abuse (NIDA). Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by National Institute on Drug Abuse (NIDA) · Not applicable, Interventional, and Basic science
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Among 68 studies in Tobacco Use Disorder by National Institute on Drug Abuse (NIDA) — 2 open to participants now, 2 under way, none of them phase 3. Tobacco Use Disorder · National Institute on Drug Abuse (NIDA).
Among the 68 studies in Tobacco Use Disorder by National Institute on Drug Abuse (NIDA), this one is the 15th largest by planned enrollment of the 47 interventional ones that give a count, is the only one that started in 2023, is one of 7 with no phase, and was the 68th registered.
1,028 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
Browse Tobacco Use Disorder studies →2 of the 68 studies in Tobacco Use Disorder by National Institute on Drug Abuse (NIDA) are open now, in 1 country. Recruiting first, the newest first:
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 18–80 · Healthy volunteers
By country, each count listing its studies:
Of the 95 Tobacco Use Disorder studies recruiting now, 42 (44%) set no upper age limit and 50 (53%) stop at 75 or younger; 6 take children under 18; 37 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
68 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 27 · Phase 3 7 · Phase 4 4
First in 1995; this study’s year is marked. 1 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 140 is above the median of 90 across 893 interventional studies indexed under Tobacco Use Disorder.
Median enrollment 90 across the 47 interventional studies, 72 across the 21 observational. Of the 62 that completed or were terminated, 4 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 68 studies in Tobacco Use Disorder by National Institute on Drug Abuse (NIDA), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant s ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant s impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals.
Objectives:
The objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm.
Endpoints:
In nicotine-dependent individuals, suvorexant s impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward/cognition as well as impacts the pharmacological influence of methylphenidate on those same measures.
Study Population:\<TAB>
Nicotine dependence arm:140 subjects; Volunteers who are between the ages of 18-60 and are daily smokers/vapers.
Control arm: 80 subjects; Volunteers who are between the ages of 18-60 and are non-smokers/vapers
This study will be conducted at the NIDA-IRP, Biomedical Research Center, in Baltimore, MD.
Description of Study Intervention:
Nicotine dependence arm: Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days.
Control arm: 1. Tolerability visit with one MRI scan post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max)
Study Duration:
5 years
Participant Duration:
1-2 months
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. Substantial preclinical research indicates that orexin antagonism blunts the internally and externally triggered motivation to attain abused substances. This research project will translate these preclinical findings into the clinical domain by administering the FDA approved orexin antagonist, suvorexant, to those with a substance use disorder. Suvorexant's ability to blunt neurobiological correlates of substance misuse will be assessed. This will be assessed following acute and repeated drug administration. Baseline individual differences will be considered to determine whether neurobiological variance influences suvorexant's impact in those with nicotine dependence. In an independent arm, the interaction between suvorexant and a dopamine agonist (methylphenidate) on cognitive function will be assessed in non-smoking individuals.
Objectives:
The objective is to determine the acute and chronic impact of the orexin antagonist, suvorexant, on neurobiological and behavioral factors linked with substance use disorders. Whether such effects are mediated by baseline characteristics will be tested. Given suvorexant is an FDA approved treatment for insomnia, sleep will be evaluated as well in the nicotine dependent arm.
Endpoints:
In nicotine-dependent individuals, suvorexant's impact on brain function will be assessed several ways by evaluating: 1) resting function, 2) reactivity to drug cues, 3) reactivity to non-drug related cognitive tasks. Sleep and nicotine use will be measured throughout the study period. In those without nicotine-dependence, the impact of suvorexant and the interaction of acute methylphenidate and suvorexant on brain function will be assessed. This arm will provide insight into how suvorexant impacts reward/cognition as well as impacts the pharmacological influence of methylphenidate on those same measures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
All Participants
Nicotine Dependence Arm
-Participants must smoke/vape a minimum of 4 times per week 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).
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
All Participants
Nicotine Dependent Arm
Control Arm
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
80 Volunteers who are between the ages of 18-60 and are non-smokers/vapers. 1. Baseline visit with 1 fMRI scans pre- and post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max)
Drug: Belsomra · Drug: Placebo · Drug: Methylphenidate
140 Volunteers who are between the ages of 18-60 and are daily smokers/vapers. Suvorexant at 10 mg single dose, and Suvorexant at 10 mg daily for approximately 7 days.
Drug: Belsomra · Drug: Placebo
randomized, double-blind, placebo-controlled crossover design study: Participants will undergo a baseline scan followed by 2 acute drug administration scans where suvorexant or placebo is administered in a randomized manner where both the participant and study staff administering drug are blind. Following the second acute scan, participants will continue with the drug they received at Scan 2 for approximately 7 days. After the first chronic scan, participants will switch to the other drug for an additional approximately 7 days and then scanned a final time.
comparator taken for approximately 10 days
Control Arm: Baseline visit with 2 fMRI scans pre- and post-20mg methylphenidate, 4 acute drug administration (6-14 days in randomized order: 1. Placebo + placebo; 2. 20mg suvorexant + Placebo; 3. Placebo + 40mg methylphenidate; 4. 20 mg suvorexant + 40mg methylphenidate max)
fMRI - cue reactivity
Test whether acute and/or chronic suvorexant reduces smoking/vaping cue reactivity
Time frame: each scan visit
cue reactivity and suvorexant effectiveness
Determine whether baseline variance in cue reactivity contributes to suvorexant s effectiveness
Time frame: each scan visit
task based fMRI
Determine whether suvorexant blunts reward sensitivity
Time frame: each scan visit
fMRI
to assess not only whether there is an interaction between acute methylphenidate and suvorexant on brain function and reward/cognition, but also whether any sex differences within this interaction exist
Time frame: each scan visit
wearable watch sensor
Determine the impact of suvorexant on sleep
Time frame: 2 weeks of daily watch wearing
Resting state fMRI
Determine the impact of acute and chronic suvorexant on the brain s inherent resting function
Time frame: each scan visit
Plan to share: Undecided — We plan to share data as specified in the protocol and potentially through future data transfer agreement(s). Any shared data will be stripped of identifiers prior to release for sharing. Deidentified data may be shared with properly administered databases and/or with collaborators with whom proper data sharing agreements are in place. Outside of the data sharing plan already specified in the protocol (in what would be outline in a future data sharing agreement), we have not yet finalized decisions on types of supporting information that will be shared, IPD Sharing Time Frame, IPD Sharing Access Criteria for other future data sharing agreements.
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Dec 2027, 58 months after the start.
Of 257 non-industry interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 58 months is above that.
Counting every sponsor, half of 267 studies reached it within 32 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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