Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05145764
Other study ID # IRB00301337
Secondary ID UH3DA048734
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 30, 2022
Est. completion date April 2025

Study information

Verified date June 2024
Source Johns Hopkins University
Contact Andrew S Huhn, Ph.D.
Phone 410-550-1971
Email ahuhn1@jhu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 4-week, randomized-controlled trial of suvorexant vs placebo in persons with opioid use disorder who have recent fentanyl exposure. Participants will first undergo a 5-day residential phase wherein participants are stabilized on sublingual buprenorphine/naloxone, followed by a 3-week outpatient phase wherein participants are maintained on sublingual buprenorphine/naloxone and transitioned to extended-release buprenorphine).


Description:

This study will enroll persons with opioid use disorder (N=120) who have recent fentanyl exposure (as assessed via urinalysis testing). Participants will be randomized to receive suvorexant or placebo for the duration of the study enrollment, which will serve as the between-groups experimental comparison. The study will consist of a brief (5 day) residential phase and 3-week outpatient phase. During the residential phase, all participants will be briefly maintained on a short acting opioid prior to induction onto sublingual (SL) buprenorphine (using either the buprenorphine or buprenorphine/naloxone product). At the end of the 5-day residential period, participants will be discharged to complete the ~3-week outpatient phase. During the outpatient period all participants will be maintained on SL buprenorphine/naloxone and continue to receive suvorexant or placebo, and at the end of the study participants will receive an injection of XR-buprenorphine (Sublocade). All buprenorphine procedures will be open label and will follow standard-of-care practices. Study medication during the outpatient period will be managed using an automated pill dispenser. Data collection will consist of forehead-based EEG monitoring, wrist-worn actigraphy/photoplethysmography, and questionnaires delivered during study visits or via cell-phone based ecological momentary assessments.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Aged 18-65 - Meets DSM-5 criteria for opioid use disorder (OUD) with evidence of physical dependence on opioids - Provides a urine sample that tests positive for fentanyl and/or fentanyl analogues - Interest in being maintained on buprenorphine for OUD - Plans to reside in current area for study period - Achieving a study maintenance dose of >=8mg sublingual buprenorphine/naloxone - Willing to comply with study protocol - Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation Exclusion Criteria: - Medically contraindicated for buprenorphine, extended-release (XR)-buprenorphine (Sublocade), or suvorexant (as per medication labels) - Pregnant or breast feeding - Severe Diagnostic and Statistical Manual (DSM)-5 alcohol, benzodiazepine, or stimulant use disorder or evidence of alcohol/benzodiazepine physical dependence - Have a known allergy to the study medications - Past 30-day prescribed use of suvorexant for the indication of insomnia - Current benzodiazepine or other prescribed medication for the indication of insomnia - Urine sample testing positive for benzodiazepine at screening and admission to residential treatment - Current narcolepsy, restless leg syndrome or sleep paralysis - High risk for current sleep apnea - Current (past 30-day) suicidal behaviors - Severe hepatic or renal impairment - aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3x upper limit of normal (ULN) - Total bilirubin >2x ULN - Creatinine >1.5x ULN - Past year clinically-significant psychiatric condition judged to interfere with study participation - Lack of access to stable housing (necessary for electronic pill dispenser charging) - Have circumstances that would interfere with study participation (e.g., impending jail)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Suvorexant
Encapsulated suvorexant (matched for color, weight, and size)
Placebo
Encapsulated placebo (matched for color, weight, and size)

Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Sleep Time Duration of nightly total sleep time in minutes, as measured by electroencephalography (EEG) and supplemented by actigraphy/photoplethysmography (e.g., if EEG malfunctions). 3 nights during the initial residential phase and 1 night at the end of outpatient treatment
Primary Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment Buprenorphine compliance will be assessed by the number of study days complying with buprenorphine treatment. 25 days across residential and outpatient treatment
See also
  Status Clinical Trial Phase
Recruiting NCT06021431 - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT N/A
Completed NCT06266572 - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment Phase 1
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT06200740 - Remotely Observed Methadone Evaluation N/A
Not yet recruiting NCT06441604 - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy Phase 2
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Completed NCT02593474 - Medication-Assisted Treatment for Youth With Substance Use Disorders Phase 1
Completed NCT02559973 - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder Phase 1
Completed NCT02440256 - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial N/A
Completed NCT05587998 - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users. Phase 1
Terminated NCT04577144 - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting NCT06001437 - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Completed NCT05546229 - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting NCT06416020 - Integrating MOUD in African American Community Settings (Better Together) N/A
Not yet recruiting NCT06104280 - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment N/A
Recruiting NCT06206291 - Cannabidiol for Opioid Addiction Phase 2
Completed NCT05552040 - START NOW in the Treatment of Opioid Addicted Individuals N/A
Recruiting NCT05459922 - Adjunctive Bright Light Therapy for Opioid Use Disorder N/A
Recruiting NCT05343169 - Community-based Education, Navigation, and Support Intervention for Military Veterans N/A