Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • SUVO

    Drug

    Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11

  • TAU

    Drug

    Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: SUVOExperimental treatment 2 interventions
Group B: TAUActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in total sleep duration as assessed by the actigraphy watch

Time frame
Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
2

Change in wake after sleep onset measured via actigraphy watch

Time frame
Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
3

Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI)

This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.

Time frame
Day 5 and Day 12
4

Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)

This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome

Time frame
Day 5 and Day 12

Secondary outcomes

1

Change in resting state alpha power as assessed by EEG

Time frame
Day 5 and Day 12
2

Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task

Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken

Time frame
Day 5 and Day 12
3

Change in stress as indicated by the change in heart rate during the cold-pressor task

Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured

Time frame
Day 5 and Day 12
4

Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes

Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured

Time frame
Day 5 and Day 12

Other outcomes

Sponsors and contacts

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