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Recruiting NCT06444256

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Phase II Interventional Stimulant Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SUVO, TAU.
Who it may be relevant to
Registry conditions: Stimulant Use Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug SUVO
    Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
  • Drug TAU
    Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Primary outcome measures

  • Change in total sleep duration as assessed by the actigraphy watch [Time frame: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11]
  • Change in wake after sleep onset measured via actigraphy watch [Time frame: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11]
  • Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI) [Time frame: Day 5 and Day 12]
  • Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF) [Time frame: Day 5 and Day 12]
  • Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF) [Time frame: Day 5 and Day 12]
  • Change in self-reported stress as assessed by the Visual Analog Scale (VAS) [Time frame: Day 5 and Day 12]
  • Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS) [Time frame: Day 5 and Day 12]
  • Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ) [Time frame: Day 5 and Day 12]
Secondary outcome measures (10)
  • Change in resting state alpha power as assessed by EEG [Time frame: Day 5 and Day 12]
  • Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task [Time frame: Day 5 and Day 12]
  • Change in stress as indicated by the change in heart rate during the cold-pressor task [Time frame: Day 5 and Day 12]
  • Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes [Time frame: Day 5 and Day 12]
  • Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes [Time frame: Day 5 and Day 12]
  • Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task [Time frame: Day 5 and Day 12]
  • Change in intensity of demand as assessed by the Drug Purchasing Task [Time frame: Day 5 and Day 12]
  • Length of stay (LOS) [Time frame: at time of discharge (up to 30 days form baseline)]
  • Percentage of participants who complete the 30 day treatment [Time frame: at time of discharge (up to 30 days form baseline)]
  • Change in side effects as assessed by the side effects questionnaire [Time frame: Day 5 , Day 12]

Eligibility criteria

Inclusion criteria

  • Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
  • Be fluent in English and able to understand the consent form

Exclusion criteria

  • Have an opioid use disorder of any severity
  • Have a greater than moderate substance use disorder on any other substance
  • Undergoing medication-assisted treatment for withdrawal of any substance
  • 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)
  • Are currently taking medications with known drug interactions with SUVO (e.g., Monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
  • Are pregnant or breast feeding
  • BMI > 30 (women only)
  • Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
  • Have history of seizure disorder
  • Have a head injury with loss of consciousness in the last 5 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06444256 · HSC-MS-24-0330

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗