Clinical trial NCT06444256: Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder
Official title: Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stimulant Use Disorder
Keywords: Psychostimulants
substance use
methamphetamine
cocaine
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in total sleep duration as assessed by the actigraphy watch
timeFrame: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
measure: Change in wake after sleep onset measured via actigraphy watch
timeFrame: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
measure: Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI)
timeFrame: Day 5 and Day 12
measure: Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
timeFrame: Day 5 and Day 12
measure: Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
timeFrame: Day 5 and Day 12
measure: Change in self-reported stress as assessed by the Visual Analog Scale (VAS)
timeFrame: Day 5 and Day 12
measure: Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)
timeFrame: Day 5 and Day 12
measure: Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)
timeFrame: Day 5 and Day 12
Secondary outcomes:
measure: Change in resting state alpha power as assessed by EEG
timeFrame: Day 5 and Day 12
measure: Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task
timeFrame: Day 5 and Day 12
measure: Change in stress as indicated by the change in heart rate during the cold-pressor task
timeFrame: Day 5 and Day 12
measure: Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes
timeFrame: Day 5 and Day 12
measure: Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes
timeFrame: Day 5 and Day 12
measure: Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
timeFrame: Day 5 and Day 12
measure: Change in intensity of demand as assessed by the Drug Purchasing Task
timeFrame: Day 5 and Day 12
measure: Length of stay (LOS)
timeFrame: at time of discharge (up to 30 days form baseline)
measure: Percentage of participants who complete the 30 day treatment
timeFrame: at time of discharge (up to 30 days form baseline)
measure: Change in side effects as assessed by the side effects questionnaire
timeFrame: Day 5 , Day 12
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Heather Webber, PhD
role: PRINCIPAL_INVESTIGATOR
References: