Recruiting
Phase 2

Orexin Receptor Antagonism

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06444256

Conditions

Stimulant Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

SUVO

TAU

Study Details

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

Study ID

NCT06444256

Start date

Jul 25, 2024

Status verified date

Sep, 2025

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SUVO

active comparator: TAU

Interventions

SUVO

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

TAU

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Heather Webber, PhD

713-486-2723Heather.E.Webber@uth.tmc.edu

Jessica Vincent

713-486-2645Jessica.N.Vincent@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Heather Webber, PhD

713-486-2723Heather.E.Webber@uth.tmc.edu

Jessica Vincent

713-486-2645Jessica.N.Vincent@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 5, 2025

Last verified

Sep, 2025

Keywords

  • Psychostimulants
  • substance use
  • methamphetamine
  • cocaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-09-05.