Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Purpose

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

Condition

  • Stimulant Use Disorder

Eligibility

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

Inclusion Criteria

  • Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine) - Be fluent in English and able to understand the consent form

Exclusion Criteria

  • Have an opioid use disorder of any severity - Have a greater than moderate substance use disorder on any other substance - Undergoing medication-assisted treatment for withdrawal of any 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., Monoamine oxidase (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
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SUVO
  • Drug: SUVO
    Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
  • Drug: TAU
    Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.
Active Comparator
TAU
  • Drug: TAU
    Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Heather Webber, PhD
713-486-2723
Heather.E.Webber@uth.tmc.edu

More Details

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

Study Contact

Heather Webber, PhD
713-486-2723
Heather.E.Webber@uth.tmc.edu