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Abuse, DrugPhase 1NCT04110535

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

A Phase 1 study testing Remimazolam, Midazolam and Saline in people with Abuse, Drug, run by Paion UK Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Abuse, Drug
What is being tested?
Remimazolam, Midazolam and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
1 siteUnited States
Study dates
23 Jun 2015to 6 Oct 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • ≥ 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
  • Must pass Qualification Phase (Drug Discrimination and Tolerability) eligibility criteria (Section 9.3.1 and 9.3.2, respectively).
  • Female subjects must be of non-childbearing potential (postmenopausal, with > 1 year since last menses and a follicular stimulating hormone (FSH) value > 40 mIU/mL, or surgically or congenitally sterile), or, if of childbearing potential, must be using and willing to continue using highly effective contraception, defined as methods of birth control that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or a vasectomized partner, for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 14 days after last study drug administration.
  • Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
  • Must be willing to comply with the requirements and restrictions of the study.

Who cannot join

  • 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).
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  • Unexplained significant and recent loss of consciousness, or history of significant head trauma with loss of consciousness.
  • Reported history of acute narrow-angle glaucoma.
  • Required concomitant treatment with any prescription or non-prescription medications (with the exception of hormonal contraceptives, hormone replacement, and acetaminophen) or natural health products (herbal remedies), including strong cytochrome P450 (CYP) 3A4 inhibitors or respiratory depressants, or could not safely discontinue these medications within 7 days or 5 half -lives (whichever is longer) prior to receiving study drug in the Qualification Phase and for the Duration of the study.
  • Subject was using an investigational drug or device or had used such within the 30 days (or 5 half-lives, whichever is longer) prior to first drug administration in the Qualification Phase.
  • Female subjects who were pregnant or lactating or who were planning to become pregnant within 14 days of last study drug administration.
  • Subject had a prior history of any significant adverse reactions (including rash) to benzodiazepines and/or flumazenil, or known allergies to midazolam and/or flumazenil, or formulation components.
  • Subject had unsuitable or difficult venous access or was unwilling or unable to undergo catheter insertion.
  • Subject was an employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • A subject who, in the opinion of the investigator, was considered unsuitable or unlikely to comply with the study protocol for any reason (in each case, the investigator had to specify the reason).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PRA Health Sciences Early Development Services

    Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: 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

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

Conditions
Abuse, Drug
Being tested
Remimazolam, Midazolam, Saline
Keywords
remimazolam
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Also called CNS7056

    IV administration over 1 minute

  • MidazolamDrug

    IV administration over 1 minute

  • SalineOther

    IV administration over 1 minute

Study groups in NCT04110535
Study groupRoleWhat they receive
Remimazolam 5 mgExperimentalIV administration of remimazolam 5 mg
Receives: Drug: Remimazolam
Remimazolam 10 mgExperimentalIV administration of remimazolam 10 mg
Receives: Drug: Remimazolam
Midazolam 2.5 mgActive comparatorIV administration of midazolam 2.5 mg
Receives: Drug: Midazolam
Midazolam 5 mgActive comparatorIV administration of midazolam 5 mg
Receives: Drug: Midazolam
PlaceboPlacebo comparatorSaline injection
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug Liking VAS maximum effect (Emax)

    Maximum effect (Emax) on the bipolar Drug Liking visual analogue scale (VAS)

    Measured: 2 to 480 minutes postdose

Secondary outcomes (9)

  1. Drug Liking VAS Minimum effect [Emin]

    Minimum effect (Emin) on the bipolar Drug Liking visual analogue scale (VAS)

    Measured: 2 to 480 minutes postdose

  2. Overall Drug Liking VAS (Emax/Emin)

    Emax/Emin on the bipolar Drug Liking visual analogue scale (VAS)

    Measured: 240 to 480 minutes postdose

  3. Take Drug Again VAS (Emax)

    Maximum effect (Emax) on the unipolarTake Drug Again visual analogue scale (VAS)

    Measured: 240 to 480 minutes postdose

  4. Good Effects VAS (Emax and TA_AUE)

    Maximum effect (Emax) and TA_AUE on the unipolar Good Effects visual analogue scale (VAS)

    Measured: 2 to 480 minutes postdose

  5. Bad Effects VAS (Emax and TA_AUE)

    Maximum effect (Emax) and TA_AUE on the unipolar Bad Effects visual analogue scale (VAS)

    Measured: 2 to 480 minutes postdose

  6. Alertness/Drowsiness VAS (Emin and TA_AUE)

    Minimum effect (Emin) and TA_AUE on the bipolar Alertness/Drowsiness visual analogue scale (VAS)

    Measured: Predose to 480 minutes postdose

  7. Agitation/Relaxation VAS (Emin and TA_AUE)

    Minimum effect (Emin) and TA_AUE on the bipolar Agitation/Relaxation visual analogue scale (VAS)

    Measured: Predose to 480 minutes postdose

  8. Any Effects VAS (Emax and TA_AUE)

    Maximum effect (Emax) and TA_AUE on the unipolar Any Effects visual analogue scale (VAS)

    Measured: 2 to 480 minutes postdose

  9. Paired Associates Learning (PAL) total error score (Emax and TA_AUE)

    PAL test was conducted using the software CANTAB (Cambridge Cognition)

    Measured: Predose to 480 minutes postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start23 Jun 2015
  3. Primary completion6 Oct 2015
  4. Study completion6 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110535
Sponsor's protocol ID
CNS7056-014
Status last verified
Sep 2019
First submitted
27 Sep 2019
Last updated
1 Oct 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Remimazolam, Midazolam and Saline in people with Abuse, Drug, run by Paion UK Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug Liking VAS maximum effect (Emax) (time frame: 2 to 480 minutes postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.

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