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

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and each scan visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

cue reactivity and suvorexant effectiveness

fMRI

fMRI - cue reactivity

+1 more

Secondary study objectives

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

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