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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
1 week Placebo, then 1 week suvorexant (SUVO) 		After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication
  • Drug: suvorexant (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.
  • Drug: 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.
Experimental
1 week suvorexant (SUVO), then 1 week Placebo 		After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo
  • Drug: suvorexant (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.
  • Drug: 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.

More Details

Status
Terminated
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.