DNA DamagePhase 1NCT03893617
Brief Stresses Experimental Study
A Phase 1 study testing Propranolol, Acute stress task and No stress task in people with DNA Damage and Psychological Stress, run by Dana Bovbjerg at 1 site in United States.
Trial summary
The goal of this study is to examine the impact of psychological stress on DNA integrity by conducting an experiment under controlled conditions with healthy volunteers to directly test the extent to which acute stress increases DNA damage, while simultaneously testing the blocking effects of pre-treatment with… Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Damage, Psychological Stress
- What is being tested?
- Propranolol, Acute stress task and No stress task
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 27 Jan 2022
- 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 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-59
- Weigh at least 110 pounds
- Fasting blood sugar below 150 mg/dL, or random blood sugar below 200 mg/dL
- Thyroid stimulating hormone level between 0.25 mU/L and 6.0 mU/L
- Resting blood pressure below 160/100 mm Hg
- If female, have either regular menstrual periods (21-35 days) or are post-menopausal
Who cannot join
- Use of illicit drugs or nicotine-containing products other than cigarettes in the past month
- Current alcohol abuse
- Diagnosed with any of the following: cancer (other than basal cell skin cancer), chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), severe traumatic brain injury, hypertension (high blood pressure), coronary artery disease, congestive heart failure, or other serious heart disease
- Current diabetes, asthma, depression, bipolar disorder, anxiety, or schizophrenia
- If female, pregnancy or breastfeeding within the past 3 months
- If female, taking any medications that prevent monthly menstrual cycles (e.g., birth control shot, IUD, "seasonal" birth control)
- Resting systolic blood pressure of < 90 mm Hg or resting pulse < 50 beats per minute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Stresses and DNA Integrity: An Experimental Analysis
The goal of this study is to examine the impact of psychological stress on DNA integrity by conducting an experiment under controlled conditions with healthy volunteers to directly test the extent to which acute stress increases DNA damage, while simultaneously testing the blocking effects of pre-treatment with propranolol, and exploring key hypothesized mediators and moderators of the severity of the DNA damage.
- Conditions
- DNA Damage, Psychological Stress
- Being tested
- Propranolol, Placebo oral capsule, Acute stress task, No stress task
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
A single oral dose (80mg) of propranolol will be administered in a blinded capsule at the start of the baseline monitoring period of the acute stress study visit.
Placebo oral capsuleDrug
A single blinded capsule containing no active medication will be administered at the start of the baseline monitoring period of the acute stress study visit.
Acute stress taskBehavioural
Participants will complete speech and arithmetic tasks, performed in front of an audience (e.g., researcher staff members) and recorded by a video camera to assess non-verbal behaviors and evaluate performance. The task will be initiated following completion of baseline sample collection during the acute stress study visit and will take approximately 15 minutes.
No stress taskBehavioural
Participants will sit quietly for 5 minutes, read a short passage aloud for 5 minutes, and read a list of numbers aloud for 5 minutes. The task will be initiated following completion of baseline sample collection during the no stress study visit and will take approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Propranolol group | Active comparator | This group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit. Receives: Drug: Propranolol; Behavioral: Acute stress task; Behavioral: No stress task |
| Placebo group | Placebo comparator | This group will receive a single blinded capsule containing no active medication during their acute stress study visit. Receives: Drug: Placebo oral capsule; Behavioral: Acute stress task; Behavioral: No stress task |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Stress Response
Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples
Measured: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period
Secondary outcomes (10)
DNA Stress Response (8-OHdG)
Change in DNA 8-OHdG levels will be measured in blood samples
Measured: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
DNA Stress Response (γ-H2AX)
Change in cellular γ-H2AX levels will be measured in blood samples
Measured: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Neuroendocrine Stress Response (Norepinephrine (NE))
Change in circulating plasma NE levels will be measured in blood samples
Measured: Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
Neuroendocrine Stress Response (Epinephrine (EPI))
Change in circulating plasma EPI levels will be measured in blood samples
Measured: Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
Hematological Stress Response
Change in the white blood cell populations present in blood samples will be measured through complete blood count with differential analysis and flow cytometry
Measured: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Cardiovascular Stress Response (Heart rate (HR))
Change in HR will be calculated from repeated assessments
Measured: HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Cardiovascular Stress Response (Systolic blood pressure (SBP))
Change in SBP/DBP will be calculated from repeated assessments
Measured: Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Cardiovascular Stress Response (Diastolic blood pressure (DBP))
Change in DBP will be calculated from repeated assessments
Measured: Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Psychological Stress Response (Anxiety Visual Analogue Scale (VAS))
Change in anxiety levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling anxious and 100 indicates feeling highly anxious
Measured: Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
Psychological Stress Response (Stress Visual Analogue Scale (VAS))
Change in stress levels will be assessed by self-report measure (VAS) on a 0 to 100 scale, where 0 indicates not feeling stressed and 100 indicates feeling highly stressed
Measured: Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start5 Oct 2017
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Why it stopped: Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA DamageStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana Bovbjerg
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Dana Bovbjerg, University of Pittsburgh
- Investigators
- Dana Bovbjerg, PhD, Principal investigator, University of PittsburghFrank Jenkins, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893617
- Sponsor's protocol ID
- PRO16080092
- Other IDs
- R01CA211371
- Status last verified
- Jul 2023
- First submitted
- 26 Mar 2019
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Stresses and DNA Integrity: An Experimental Analysis
- ClinicalTrials.gov ID
- NCT03893617
- Acronym / sponsor ID
- PRO16080092
- Conditions
- DNA Damage, Psychological Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Dana BovbjergUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 28 Mar 2019 (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 goal of this study is to examine the impact of psychological stress on DNA integrity by conducting an experiment under controlled conditions with healthy volunteers to directly test the extent to which acute stress increases DNA damage, while simultaneously testing the blocking effects of pre-treatment with propranolol, and exploring key hypothesized mediators and moderators of the severity of the DNA damage.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol group | Active comparator | Drug: Propranolol, Behavioral: Acute stress task, Behavioral: No stress taskThis group will receive a single oral dose (80mg) of propranolol in a blinded capsule during their acute stress study visit. |
| Placebo group | Placebo comparator | Drug: Placebo oral capsule, Behavioral: Acute stress task, Behavioral: No stress taskThis group will receive a single blinded capsule containing no active medication during their acute stress study visit. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 20-59
- Weigh at least 110 pounds
- Fasting blood sugar below 150 mg/dL, or random blood sugar below 200 mg/dL
- Thyroid stimulating hormone level between 0.25 mU/L and 6.0 mU/L
- Resting blood pressure below 160/100 mm Hg
Key exclusion criteria (7 listed)
- Use of illicit drugs or nicotine-containing products other than cigarettes in the past month
- Current alcohol abuse
- Diagnosed with any of the following: cancer (other than basal cell skin cancer), chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), severe traumatic brain injury, hypertension (high blood pressure), coronary artery disease, congestive heart failure, or other serious heart disease
- Current diabetes, asthma, depression, bipolar disorder, anxiety, or schizophrenia
- If female, pregnancy or breastfeeding within the past 3 months
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 |
|---|---|---|
| PropranololA single oral dose (80mg) of propranolol will be administered in a blinded capsule at the start of the baseline monitoring period of the acute stress study visit. | Drug | Propranolol group |
| Placebo oral capsuleA single blinded capsule containing no active medication will be administered at the start of the baseline monitoring period of the acute stress study visit. | Drug | Placebo group |
| Acute stress taskParticipants will complete speech and arithmetic tasks, performed in front of an audience (e.g., researcher staff members) and recorded by a video camera to assess non-verbal behaviors and evaluate performance. The task will be initiated following completion of baseline sample collection during the acute stress study visit and will take approximately 15 minutes. | Behavioural | Placebo group, Propranolol group |
| No stress taskParticipants will sit quietly for 5 minutes, read a short passage aloud for 5 minutes, and read a list of numbers aloud for 5 minutes. The task will be initiated following completion of baseline sample collection during the no stress study visit and will take approximately 15 minutes. | Behavioural | Placebo group, Propranolol group |
Primary outcome
DNA Stress Response
Time frame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period
Change in percent tail intensity will be measured using the Comet assay of DNA damage in blood samples
10 secondary outcomes
DNA Stress Response (8-OHdG)
Time frame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
DNA Stress Response (γ-H2AX)
Time frame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Neuroendocrine Stress Response (Norepinephrine (NE))
Time frame: Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
Neuroendocrine Stress Response (Epinephrine (EPI))
Time frame: Blood samples will be collected after a 60 minute baseline period and during/after the approximately 15 minute task period
Hematological Stress Response
Time frame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute task period
Cardiovascular Stress Response (Heart rate (HR))
Time frame: HR will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Cardiovascular Stress Response (Systolic blood pressure (SBP))
Time frame: Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Cardiovascular Stress Response (Diastolic blood pressure (DBP))
Time frame: Blood pressure will be assessed throughout the 60 minute baseline period and during/after the approximately 15 minute task period
Psychological Stress Response (Anxiety Visual Analogue Scale (VAS))
Time frame: Anxiety VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
Psychological Stress Response (Stress Visual Analogue Scale (VAS))
Time frame: Stress VAS will be administered after a 60 minute baseline period and during/after completion of the tasks
Results and safety
The study was stopped early (reason given: Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
Dana Bovbjerg, PhD principal investigator
University of Pittsburgh
Frank Jenkins, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propranolol, Acute stress task and No stress task in people with DNA Damage and Psychological Stress, run by Dana Bovbjerg 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Jul 2023. 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 was stopped early (reason given: Due to challenges associated with the Covid-19 pandemic, we were unable to complete recruitment as planned during the period we had funding to do so.). Results are not available in the source record.
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?
DNA Stress Response (time frame: Blood samples will be collected after a 60 minute baseline period and after the approximately 15 minute acute stress task period). 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 18 Jul 2023.