ScopolaminePhase 1NCT04999449
Nebulizer Delivery of Intranasal Scopolamine
A Phase 1 study testing Scopolamine in people with Scopolamine and Motion Sickness, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer. Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Scopolamine, Motion Sickness
- What is being tested?
- Scopolamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 7 May 2025
- 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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Adults age 21-49
- Normal weight for body size, based on BMI table
- General good health, as determined by a verbally provided medical history
- Normal brief neurological exam
- Renal and hepatic function within normal ranges
- Able to provide written informed consent to participate
Who cannot join
- Drug allergies to scopolamine or other belladonna alkaloid
- Use of medications within 1 week of starting the study
- Use of an investigational drug within 30 days of starting the study
- Tobacco smoking within the past year
- Blood donation or significant blood loss within 30 days of starting the study
- Significant gastrointestinal disorder (e.g. Crohn's Disease, ulcerative colitis, chronic constipation), asthma, glaucoma, prostate problems, urinary obstruction, or seizure disorders
Show all 17Show fewer
- History of alcohol or other drug abuse
- Pregnancy or suspected pregnancy, or lactation (pregnancy will be confirmed with urine pregnancy testing prior to drug administration)
- Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration
- Nasal, nasal sinus, or nasal mucosa surgery within 90 days prior to study initiation
- Other significant surgeries within 90 days
- Significant deviated septum that blocks air flow in one nostril
- Rhinitis, sinus infection, severe allergies, and other upper respiratory infections within 30 days prior to the study
- Current use of an intranasal medication
- Wheezing or other respiratory problem
- Unable to consent
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.
Read the detailed description
An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.
- Conditions
- Scopolamine, Motion Sickness
- Being tested
- Scopolamine, Placebo
- Keywords
- Scopolamine, Motion Sickness, Space Physiology
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopolamineDrug
Intranasal scopolamine at 0.2 mg or 0.4 mg
PlaceboDrug
Intranasal saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic | Experimental | Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC. Receives: Drug: Scopolamine |
| Chair | Experimental | Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized. Receives: Drug: Scopolamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to maximal concentration for scopolamine after intranasal administration (Tmax)
Plasma scopolamine concentrations will be measured using an liquid chromatography-mass spectrometry (LC- MS) assay. Tmax is measured in minutes to reach the maximum concentration.
Measured: Baseline, 180 minutes
Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale
A questionnaire will be administered asking about the participant's side effect profile after taking intranasal scopolamine. The questionnaire will have a subjective rating scale of 0-10 on the potential scopolamine side effects expected
Measured: 180 minutes
Secondary outcomes (1)
Effectiveness in reducing motion sickness as measured by duration of chair ride.
The degree of motion sickness will be assessed by measuring the total number of minutes the subject rides in the chair before stopping
Measured: Baseline, end of chair ride (maximum of 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start24 Jan 2022
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScopolamineStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay C. Buckey Jr., Dartmouth-Hitchcock Medical Center
- Investigators
- Jay C Buckey, Ph.D, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999449
- Sponsor's protocol ID
- STUDY02001115
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulizer Delivery of Intranasal Scopolamine
- ClinicalTrials.gov ID
- NCT04999449
- Acronym / sponsor ID
- STUDY02001115
- Conditions
- Scopolamine, Motion Sickness
- Keywords
- Scopolamine, Motion Sickness, Space Physiology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 10 Aug 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.
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.
Detailed description
An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pharmacokinetic study followed by double-blind, placebo-controlled, dose-ranging design
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic | Experimental | Drug: ScopolamineParticipants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC. |
| Chair | Experimental | Drug: Scopolamine, Drug: PlaceboParticipants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female
- Adults age 21-49
- Normal weight for body size, based on BMI table
- General good health, as determined by a verbally provided medical history
- Normal brief neurological exam
Key exclusion criteria (17 listed)
- Drug allergies to scopolamine or other belladonna alkaloid
- Use of medications within 1 week of starting the study
- Use of an investigational drug within 30 days of starting the study
- Tobacco smoking within the past year
- Blood donation or significant blood loss within 30 days of starting the study
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 |
|---|---|---|
| ScopolamineIntranasal scopolamine at 0.2 mg or 0.4 mg | Drug | Chair, Pharmacokinetic |
| PlaceboIntranasal saline placebo | Drug | Chair |
Primary outcome
Time to maximal concentration for scopolamine after intranasal administration (Tmax)
Time frame: Baseline, 180 minutes
Plasma scopolamine concentrations will be measured using an liquid chromatography-mass spectrometry (LC- MS) assay. Tmax is measured in minutes to reach the maximum concentration.
Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale
Time frame: 180 minutes
A questionnaire will be administered asking about the participant's side effect profile after taking intranasal scopolamine. The questionnaire will have a subjective rating scale of 0-10 on the potential scopolamine side effects expected
1 secondary outcome
Effectiveness in reducing motion sickness as measured by duration of chair ride.
Time frame: Baseline, end of chair ride (maximum of 20 minutes)
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Jay C Buckey, Ph.D principal investigator
Dartmouth-Hitchcock Medical Center
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 Scopolamine in people with Scopolamine and Motion Sickness, run by Dartmouth-Hitchcock Medical Center 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 7 inclusion and 17 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 28 Aug 2025. 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. 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?
Time to maximal concentration for scopolamine after intranasal administration (Tmax) (time frame: Baseline, 180 minutes). 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 28 Aug 2025.