RECRUITING

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

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Conditions

Stimulant Use DisorderPsychostimulantssubstance usemethamphetaminecocaine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

Official Title

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study

Quick Facts

Study Start:2024-07-25
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06444256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
  2. * Be fluent in English and able to understand the consent form
  1. * Have an opioid use disorder of any severity
  2. * Have a greater than moderate substance use disorder on any other substance
  3. * Undergoing medication-assisted treatment for withdrawal of any substance
  4. * Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
  5. * Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
  6. * Are pregnant or breast feeding
  7. * BMI \> 30 (women only)
  8. * Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
  9. * Have history of seizure disorder
  10. * Have a head injury with loss of consciousness in the last 5 years

Contacts and Locations

Study Contact

Heather Webber, PhD
CONTACT
713-486-2723
Heather.E.Webber@uth.tmc.edu
Jessica Vincent
CONTACT
713-486-2645
Jessica.N.Vincent@uth.tmc.edu

Principal Investigator

Heather Webber, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Heather Webber, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-07-25
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Psychostimulants
  • substance use
  • methamphetamine
  • cocaine

Additional Relevant MeSH Terms

  • Stimulant Use Disorder