CompletedPhase 1

Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users

United States83 participantsStarted 2015-06-23

Plain-language summary

A double-blind, randomized crossover study to assess the subjective abuse potential of intravenous remimazolam compared to midazolam and placebo in recreational CNS depressant users

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have provided written informed consent prior to the initiation of any protocolspecific procedures.
✓. Male and female adults, between 18 and 55 years of age, inclusive.
✓. Body mass index (BMI) within 19.0 to 33.0 kg/m2, inclusive (minimum weight of at least 50.0 kg at Screening).
✓. Healthy, as determined by having no clinically significant medical history, physical examination, 12-lead ECG, vital signs, or laboratory (including hematology, clinical chemistry, urinalysis, and serology) findings, as judged by the investigator.
✓. Recreational CNS depressant user, defined as follows:
✓. ≥ 10 lifetime non-therapeutic experiences (ie, for psychoactive effects) with CNS depressants (eg, benzodiazepines, barbiturates, opioids, zolpidem, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate)
✓. ≥ 1 non-therapeutic use of a CNS depressant within the 8 weeks prior to Screening
✓. ≥ 1 non-therapeutic use of benzodiazepines within the 12 months prior to Screening

Exclusion criteria

✕. Drug or alcohol dependence within the 12 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Man ual of Mental Disorders, fourth edition, text revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
✕. Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
✕. History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease at Screening, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results, including subjects with chronic renal failure or congestive heart failure.
✕. In the opinion of the investigator, the subject was at risk for respiratory depression, including subjects with obstructive apnea, upper airway obstruction, chronic obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, or other severe cardio-respiratory disease.
✕. Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
✕. History of, or evidence at the time for, suicidal ideation with intent, with or without a plan or method, in the past 5 years or suicidal behavior in their lifetime or those who were actively suicidal based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
✕. Unexplained significant and recent loss of consciousness, or history of significant head trauma with loss of consciousness.
✕. Reported history of acute narrow-angle glaucoma.

What they're measuring

Drug Liking VAS maximum effect (Emax)

Timeframe: 2 to 480 minutes postdose

Trial details

NCT IDNCT04110535

SponsorPaion UK Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-10-06

View on ClinicalTrials.gov More Abuse, Drug trials