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Suvorexant to Reduce Symptoms of Nicotine Use

Suvorexant to Reduce Symptoms of Nicotine Use

Non Recruiting
18-65 years
All
Phase 2

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Overview

The purpose of this study is to assess the impact of suvorexant on established measures of smoking relapse risk (craving,withdrawal, stress reactivity, latency to self-administration) and to validate the somnolent effect of suvorexant on sleep metrics in a sample of individuals with tobacco use disorder

Eligibility

Inclusion Criteria:

  • non-treatment seeking cigarette smokers that report smoking atleast 10 cigarettes per day

Exclusion Criteria:

  • greater than mild substance use disorder on drugs other than nicotine
  • a Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
  • significant current suicidal or homicidal ideation - medical conditions contraindicating administration of suvorexant (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
  • taking medications known to have significant drug interactions with the study medication(s) (e.g., Monoamine oxidase inhibitors(MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and all sedatives)
  • currently or recently (last 3 months) treated for substance use [other than nicotine] or another psychiatric condition
  • conditions of probation or parole requiring reports of drug use to officers of the court
  • impending incarceration
  • pregnant or nursing for female patients
  • inability to read, write, or speak English [required for lab tasks and psychometric scales]
  • unwillingness to sign a written informed consent form
  • subjects with alcohol use disorders or report recent problem drinking (5/4 drinks for males/females in < 2.5 hours or > 10 alcoholic drinks per week)
  • any illness,condition, or use of medications which in the opinion of the PI and/or admitting physician would preclude safe and/or successful completion of the study.

Study details
    Smoking Cessation

NCT04234997

The University of Texas Health Science Center, Houston

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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