Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

NCT06444256 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HSC-MS-24-0330
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stimulant Use Disorder

Keywords

Psychostimulants; substance use; methamphetamine; cocaine

Outcome Measures

Primary Outcomes (8)

• Change in total sleep duration as assessed by the actigraphy watch

  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

  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)

  This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.

  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)

  This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome

  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)

  This is an 8 item questionnaire and each is scored from 1-5 for a total score range of 8-40, higher number indicating worse outcome

  Day 5 and Day 12

• Change in self-reported stress as assessed by the Visual Analog Scale (VAS)

  This is measured from 0=no stress, 10=extreme stress

  Day 5 and Day 12

• Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)

  The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week), higher score indicating a worse outcome

  Day 5 and Day 12

• Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)

  This is a 10 item questionnaire, each is scored from 0 (strongly disagree) to 6 (strongly agree) for a total score range of 0-60, higher score indicating worse outcome

  Day 5 and Day 12

Secondary Outcomes (10)

• Change in resting state alpha power as assessed by EEG

  Day 5 and Day 12

• Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task

  Day 5 and Day 12

• Change in stress as indicated by the change in heart rate during the cold-pressor task

  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

  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

  Day 5 and Day 12

Study Arms (2)

SUVO

EXPERIMENTAL

Drug: SUVO; Drug: TAU

TAU

ACTIVE COMPARATOR

Drug: TAU

Interventions

SUVO DRUG

Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11

SUVO

TAU DRUG

Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

SUVO; TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Heather Webber, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)