Clinical trial NCT05711862: The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Official title: The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Methamphetamine Use Disorder
Keywords: sleeplessness
stress
Cue reactivity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of SUVO on sleep, stress, and cue reactivity/craving and to evaluate the preliminary safety and side effects profile of suvorexant (SUVO)


Eligibility criteria: Inclusion Criteria:

* Meet DSM-5 criteria for MA use disorder
* Be fluent in English and able to understand the consent form

Exclusion Criteria:

* Have an alcohol use disorder or report binge drinking (\>7 drinks for women and \>14 drinks for men)
* Have a greater than mild substance use disorder on any other illicit 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., 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: Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
timeFrame: 7 days
measure: Resting State Alpha Power as Assessed by EEG
timeFrame: 7 days
measure: Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
timeFrame: 7 days
measure: Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: 7 days
measure: Self-reported Stress as Assessed by the Visual Analog Scale (VAS)
timeFrame: 7 days
measure: Change of Cortisol Level
timeFrame: baseline, about 32 minutes after the start of the cold pressor task
measure: Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights
timeFrame: 7 days
measure: Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights
timeFrame: 7 days
Secondary outcomes:
measure: Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method
timeFrame: 7 days
measure: Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)
timeFrame: Day 7
measure: Number of Participants Who Had Side Effects
timeFrame: 7 days
measure: Depression as Assessed by the Beck's Depression Inventory (BDI)Scale
timeFrame: 7 days
measure: Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)
timeFrame: 7 days
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: