Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Phase 2RecruitingNCT06444256

The University of Texas Health Science Center, Houston20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stimulant Use Disorder

Interventions

SUVODRUG

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

TAUDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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)

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.

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)

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

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)

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

Time frame: 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

Time frame: 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

Central 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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

Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken

Time frame: 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

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

Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured

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

Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured

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

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.

Time frame: 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

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

This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only

Time frame: Day 5 , Day 12