Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Stimulant Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444256
• Other study ID #: HSC-MS-24-0330
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Heather Webber, PhD
• Phone: 713-486-2723
• Email: Heather.E.Webber[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stimulant Use Disorder

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in resting state alpha power as assessed by EEG		Day 5 and Day 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay (LOS)		at time of discharge (up to 30 days form baseline)
Secondary	Percentage of participants who complete the 30 day treatment		at time of discharge (up to 30 days form baseline)
Secondary	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