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

Methamphetamine Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05711862
• Other study ID #: HSC-MS-22-0796
• Status: Terminated
• Phase: Phase 2
• Start date: March 9, 2023
• Est. completion date: March 28, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Methamphetamine Use Disorder

Intervention

Drug:
• SUVO
Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
• Placebo
Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

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	Self-reported sleep as assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)	This is an 18 item questionnaire, each is scored from 0(no difficulty) to 3 (severe difficulty) a higher number indicating worse sleep	7 days
Primary	Resting state alpha power as assessed by EEG		7 days
Primary	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 LPP, reflecting the motivational salience of a stimulus. In the task, the participants view images in four categories, pleasant, unpleasant, methamphetamine, and neutral.	7 days
Primary	Self-reported stress as assessed by the Depression, anxiety and Stress scale (DASS-21)	This is a 21 item questionnaire and each is scored from 0(did not apply to me at all) to 3 (apply to me very much or most of the time), higher score indicating a worse outcome	7 days
Primary	Self-reported stress as assessed by the Visual Analog Scale (VAS)	This is measured from 0=no stress, 10=extreme stress	7 days
Primary	Amount of cortisol measured	This is measured before and after the cold pressor task and measures the amount of cortisol in saliva	7 days
Primary	Total sleep time measured nightly via actigraphy watch		Nightly for 3 weeks
Primary	Wake after sleep onset measured nightly via actigraphy watch		Nightly for 3 weeks
Secondary	Number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method		7 days
Secondary	Number of days of methamphetamine use as assessed by the urine drug screen (UDS)		7 days
Secondary	Side effects as assessed by the side effects questionnaire	31 symptoms are rated using the following scale: None, Mild, Moderate, Severe	7 days
Secondary	Depression as assessed by the Beck's Depression Inventory (BDI)scale	This is a 21 item questionnaire and each is scored from 0-3 for a maximum score of 63 a higher score indicating more depression	7 days
Secondary	Suicidal ideation and behavior as assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)	This is a semi-structured interview that measures suicide ideation on a 6-point ordinal scale, ranging from 0 (no suicide ideation) to 5 (suicidal intent with plan) with a higher score indicating worse outcome	7 days