Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stimulant Use Disorder
• Intervention / Treatment: Drug: SUVO; Drug: TAU

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Heather Webber, PhD; Phone Number: 713-486-2723; Email: Heather.E.Webber@uth.tmc.edu
• Study Contact Backup: Name: Jessica Vincent; Phone Number: 713-486-2645; Email: Jessica.N.Vincent@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Heather Webber, PhD; Phone Number: 713-486-2723; Email: Heather.E.Webber@uth.tmc.edu
      • Contact: Jessica Vincent; Phone Number: 713-486-2645; Email: Jessica.N.Vincent@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAU	Drug: TAU; Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.
Experimental: SUVO	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken	Day 5 and Day 12
Change in stress as indicated by the change in heart rate during the cold-pressor task	Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured	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	Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured	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	Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured	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	The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.	Day 5 and Day 12
Change in intensity of demand as assessed by the Drug Purchasing Task	Demand is the maximum quantity of Methamphetamine or Cocaine consumed if the drug was free measured in grams or dollar amount	Day 5 and Day 12
Length of stay (LOS)		at time of discharge (up to 30 days form baseline)
Percentage of participants who complete the 30 day treatment		at time of discharge (up to 30 days form baseline)
Change in side effects as assessed by the side effects questionnaire	This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only	Day 5 , Day 12

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Heather Webber, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: methamphetamine; cocaine; substance use; Psychostimulants
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HSC-MS-24-0330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No