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Clinical trial

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

ID
Name
HSC-MS-22-0796
Description
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)
Trial arms
Trial start
2023-03-09
Estimated PCD
2024-03-28
Trial end
2024-03-28
Status
Terminated
Phase
Early phase I
Treatment
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.
Arms:
1 week Placebo then 1 week SUVO, 1 week SUVO then 1 week Placebo
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.
Arms:
1 week Placebo then 1 week SUVO, 1 week SUVO then 1 week Placebo
Size
7
Primary endpoint
Self-reported sleep as assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
7 days
Resting state alpha power as assessed by EEG
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
7 days
Self-reported stress as assessed by the Depression, anxiety and Stress scale (DASS-21)
7 days
Self-reported stress as assessed by the Visual Analog Scale (VAS)
7 days
Amount of cortisol measured
7 days
Total sleep time measured nightly via actigraphy watch
Nightly for 3 weeks
Wake after sleep onset measured nightly via actigraphy watch
Nightly for 3 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}
Updated at
2024-05-06

1 organization

2 products

1 indication

Organization
The University of Texas Health Science Center at Houston
Product
SUVO
Indication
Methamphetamine Use Disorder
Product
Placebo