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Orexin Antagonist
Belsomra + Methylphenidate for Smoking Cessation
N/A
Recruiting
Led By Amy Janes, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each scan visit
Awards & highlights
Study Summary
This trial is testing if a drug can help people stop smoking. Participants will have physicals, MRI scans, fill out questionnaires, and wear a watch-like device to track their sleep.
Who is the study for?
This trial is for daily smokers/vapers aged 18-60 who have been using nicotine consistently for at least a year. They must not use other drugs or alcohol, be pregnant, or have certain health conditions like severe heart disorders, respiratory issues, major depression (unless stable on medication), obesity with BMI over 35, or neurological disorders.Check my eligibility
What is being tested?
The study tests the drug suvorexant's impact on brain function and behavior in people with nicotine addiction. It also examines how suvorexant interacts with methylphenidate in non-smokers. Participants will take a single dose of suvorexant and then daily doses for about a week; control subjects will receive various combinations of the drugs and placebo.See study design
What are the potential side effects?
Possible side effects include drowsiness, headache, dizziness, abnormal dreams or sleep behaviors like sleepwalking. There may also be interactions between suvorexant and methylphenidate affecting alertness and cognitive functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ each scan visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each scan visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
cue reactivity and suvorexant effectiveness
fMRI
fMRI - cue reactivity
+1 moreSecondary outcome measures
Resting state fMRI
wearable watch sensor
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nicotine Dependence ArmExperimental Treatment2 Interventions
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.
Group II: Control ArmActive Control3 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)Lead Sponsor
2,469 Previous Clinical Trials
2,619,269 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction
Amy Janes, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
4 Previous Clinical Trials
1,214 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can become pregnant and will take pregnancy tests on all study days.I have never had a major head injury that affected my thinking, caused seizures, or led to other brain problems.I do not have narcolepsy.I am willing to follow the study's lifestyle requirements and have given my written consent.My BMI is 35 or less.I do not have severe breathing problems like severe sleep apnea or COPD.I don't have any health issues that prevent me from taking methylphenidate.My liver functions normally.I am not on medications that could slow down my brain function.I have no history of serious heart or brain blood vessel conditions.I cannot speak English.I am between 18 and 60 years old.I have no history of neurological disorders like seizures or cognitive issues.I have been on stable medication for my depression for 3 months.I do not have ADHD, nor have I been diagnosed with it during screening.I am not taking any medication that strongly affects liver enzymes.I do not use illicit drugs or alcohol, except for nicotine or marijuana.I have thoughts of harming myself and need more than outpatient care.I have been smoking or vaping regularly for at least a year.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Nicotine Dependence Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research grant access to adults aged over twenty?
"This clinical trial is seeking participants between the age of majority and 60 years old."
Answered by AI
Is it feasible for me to register in this clinical trial?
"The requirements for enrolment in this trial are nicotine dependence and a patient age between 18 to 60. In total, 140 people will be accepted into the program."
Answered by AI
Are there any ongoing opportunities for volunteers to participate in this experiment?
"According to clinicaltrials.gov, this particular medical trial is not currently recruiting patients; it was initially posted on December 7th 2022 and last edited on the 1st of the same month. Even though no enrollment is available for this study at present, 461 other studies are actively searching for volunteers."
Answered by AI
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