The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder

NCT05711862 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HSC-MS-22-0796
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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)

Conditions

Methamphetamine Use Disorder

Keywords

sleeplessness; stress; Cue reactivity

Outcome Measures

Primary Outcomes (8)

• Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)

  Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21, higher score indicating a worse outcome. The global PSQI score is reported.

  7 days

• Resting State Alpha Power as Assessed by EEG

  EEG will be used to assess electrical activity in the brain, specifically, to assess alpha power, which is the level of activity in the 8-12Hz frequency range. Resting state EEG means that EEG will be assessed during wakeful rest. Alpha power will be assessed in each of the 4 brain lobes (frontal, central, parietal, and occipital) for 3 minutes during eyes closed wakeful rest and also for 3 minutes during eyes open wakeful rest. Alpha Power will be reported in microvolts squared (μV²). Higher alpha power indicates more sleepiness and lower alpha power indicates less sleepiness

  7 days

• Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG

  The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and Methamphetamine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

  7 days

• Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)

  The Stress Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses stress levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating greater stress.

  7 days

• Self-reported Stress as Assessed by the Visual Analog Scale (VAS)

  The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress.

  7 days

• Change of Cortisol Level

  During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].

  baseline, about 32 minutes after the start of the cold pressor task

• Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights

  The average sleep time per night (averaged over 7 days) will be reported.

  7 days

• Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights

  The average time awake after sleep onset per night (averaged over 7 days) will be reported.

  7 days

Secondary Outcomes (5)

• Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method

  7 days

• Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)

  Day 7

• Number of Participants Who Had Side Effects

  7 days

• Depression as Assessed by the Beck's Depression Inventory (BDI)Scale

  7 days

• Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)

  7 days

Study Arms (2)

1 week Placebo, then 1 week suvorexant (SUVO)

EXPERIMENTAL

After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication

Drug: suvorexant (SUVO); Drug: Placebo

1 week suvorexant (SUVO), then 1 week Placebo

EXPERIMENTAL

After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo

Drug: suvorexant (SUVO); Drug: Placebo

Interventions

suvorexant (SUVO) DRUG

Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

1 week Placebo, then 1 week suvorexant (SUVO); 1 week suvorexant (SUVO), then 1 week Placebo

Placebo DRUG

Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

1 week Placebo, then 1 week suvorexant (SUVO); 1 week suvorexant (SUVO), then 1 week Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Heather Webber, PhD
• Organization: The University of Texas Health Science Center at Houston

Heather.E.Webber@uth.tmc.edu

713-486-2723

Study Officials

• Heather Webber, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 3, 2023
• Study Start: March 9, 2023
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)