HealthyEarly Phase 1NCT05069779
Diazepam and Blood Pressure Regulation
A Early Phase 1 study testing Diazepam in people with Healthy, run by University of Brasilia at 1 site in Brazil.
Trial summary
The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 20 May 2019
- Phase
- Early 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 40 years of age
- Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease
Who cannot join
- History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months
- Diagnosed cardiovascular or metabolic disease(s)
- Prescription of chronic medications other than oral contraceptives
- History of hypertension or presence of arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effects of Diazepam on Blood Pressure Regulation
The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.
Read the detailed description
Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.
- Conditions
- Healthy
- Being tested
- Diazepam
- Keywords
- Blood pressure, Benzodiazepine, Autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
Oral administration of 10 mg of diazepam
| Study group | Role | What they receive |
|---|---|---|
| Diazepam | Experimental | Oral Receives: Drug: Diazepam |
| Placebo | Placebo comparator | Oral Receives: Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting beat-to-beat blood pressure variability
Finger photoplethysmography
Measured: Change from baseline at 60 min
Systolic and diastolic blood pressure
Oscillometric device
Measured: Change from baseline at 60 min
Secondary outcomes (2)
Muscle sympathetic nerve activity
Microneurography
Measured: Change from baseline at 60 min
Baroreflex sensitivity
The relationship between changes in beat-to-beat blood pressure and heart rate (cardiac baroreflex) or MSNA (sympathetic baroreflex).
Measured: Change from baseline at 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Aug 2017
- Primary completion20 May 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069779
- Sponsor's protocol ID
- 70101717.1.0000.5103
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data underlying this project will be shared on reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Diazepam on Blood Pressure Regulation
- ClinicalTrials.gov ID
- NCT05069779
- Acronym / sponsor ID
- 70101717.1.0000.5103
- Conditions
- Healthy
- Keywords
- Blood pressure, Benzodiazepine, Autonomic nervous system
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the acute effects of diazepam on beat-to-beat blood pressure variability and baroreflex control.
Detailed description
Benzodiazepines are widely prescribed for a variety of clinical conditions. However, its cardiovascular consequences remain controversial. In this study, the investigators sought to determine the acute effects of a single dose of oral diazepam (10mg) on resting beat-to-beat blood pressure variability and cardiac and sympathetic baroreflex sensitivity in a cohort of young, healthy individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diazepam | Experimental | Drug: DiazepamOral |
| Placebo | Placebo comparator | Drug: DiazepamOral |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 40 years of age
- Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease
Key exclusion criteria (4 listed)
- History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months
- Diagnosed cardiovascular or metabolic disease(s)
- Prescription of chronic medications other than oral contraceptives
- History of hypertension or presence of arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiazepamOral administration of 10 mg of diazepam | Drug | Diazepam, Placebo |
Primary outcome
Resting beat-to-beat blood pressure variability
Time frame: Change from baseline at 60 min
Finger photoplethysmography
Systolic and diastolic blood pressure
Time frame: Change from baseline at 60 min
Oscillometric device
2 secondary outcomes
Muscle sympathetic nerve activity
Time frame: Change from baseline at 60 min
Baroreflex sensitivity
Time frame: Change from baseline at 60 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Yes. The data underlying this project will be shared on reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diazepam in people with Healthy, run by University of Brasilia at 1 site in Brazil.
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 2 inclusion and 4 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 6 Oct 2021. 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 Brazil. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Resting beat-to-beat blood pressure variability (time frame: Change from baseline at 60 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2021.