Medical Management of Sleep Disturbance During Opioid Tapering
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2018 |
| Start Date: | March 2019 |
| End Date: | April 2021 |
| Contact: | Andrew S Huhn, PhD |
| Email: | ahuhn1@jhu.edu |
| Phone: | 410-550-1971 |
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for
sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients
with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a
dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised
withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine
for three days before being randomly assigned to study condition. All participants will then
undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase.
Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO
and the investigators hypothesize that one or both doses of SUVO will improve total sleep
time relative to placebo.
sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients
with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a
dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised
withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine
for three days before being randomly assigned to study condition. All participants will then
undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase.
Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO
and the investigators hypothesize that one or both doses of SUVO will improve total sleep
time relative to placebo.
Inclusion Criteria:
- Aged 18 years old and above
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD
with evidence of physical dependence on opioids.
- Provides a urine sample that tests positive for opioids.
- Willing to comply with the study protocol.
- Have no clinically significant chronic medical or surgical disorders or conditions
that are judged by the investigators to prevent participation.
Exclusion Criteria:
- Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for
OUD
- Pregnant or breast feeding
- Have evidence of physical dependence on alcohol or benzodiazepines that requires
medical detoxification
- Have a known allergy to the study medications
- Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of
insomnia
- Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase
(MAO) inhibitor for depression or insomnia, or other medications that are
contraindicated with suvorexant
- Current narcolepsy, restless leg syndrome or sleep paralysis
- High risk for current sleep apnea
- Current major depressive disorder
- Past year suicidal behavior
- Severe hepatic or renal impairment
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >5x ULN
- AST or ALT >3x ULN and/or total bilirubin >2x Upper Limit of Normal (ULN)
- Creatinine >1.5x ULN
- Have circumstances that would interfere with study participation (e.g., impending
jail)
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
Baltimore, Maryland 21224
(410) 550-0100
Phone: 410-550-1971
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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