Phase 2 Sleep Disorders Trial, Recruiting NCT05145764 Sponsor: Johns Hopkins University Condition: Sleep Disorders
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Phase 2 Sleep Disorders Trial, Recruiting

NCT05145764
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 65 years old
  • People who have been diagnosed with opioid use disorder (a problematic pattern of opioid use) according to standard medical criteria, with signs of physical dependence on opioids
  • People whose urine test shows the presence of fentanyl or a similar substance
  • People who are interested in being treated with buprenorphine for opioid use disorder
  • People who plan to stay in their current area for the full length of the study
  • People who are able to reach and maintain a daily dose of at least 8mg of a buprenorphine/naloxone tablet placed under the tongue
  • People who are willing to follow all study rules and procedures
  • People who do not have serious ongoing medical or surgical conditions that the study doctors consider would prevent safe participation

Who may not be able to join:

  • People for whom buprenorphine, long-acting injectable buprenorphine (Sublocade), or the sleep medication suvorexant is medically unsuitable according to their prescribing information
  • People who are pregnant or breastfeeding
  • People with a severe alcohol or benzodiazepine use disorder, or signs of physical dependence on alcohol or benzodiazepines
  • People with a known allergy to any of the study medications
  • People who have been prescribed suvorexant for sleep problems in the past 30 days
  • People who are currently taking benzodiazepines or any other prescribed medication for sleep problems
  • People whose urine test is positive for benzodiazepines at the screening visit or when entering the residential treatment program
  • People who currently have narcolepsy, restless leg syndrome, or sleep paralysis
  • People considered at high risk for sleep apnea
  • People who have had suicidal behaviours in the past 30 days
  • People with severely reduced liver or kidney function, based on specific blood test results (confirm with trial site for exact values)
  • People who have had a clinically significant mental health condition in the past year that the study doctors judge would interfere with participation
  • People who do not have access to stable housing, as an electronic pill dispenser that requires charging is part of the study
  • People whose personal circumstances, such as an upcoming period of incarceration, would prevent them from completing the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Andrew S Huhn, Ph.D., Johns Hopkins University

Phone: 410-550-1971

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 March 2022
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Total Sleep Time; Buprenorphine compliance as assessed by the number of study days complying with buprenorphine treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov