Alcohol DrinkingNCT04659278
Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
A study testing Endourage 1200 mg OMD ™ Oral Mucosal Drops, Isolate and Peppermint Oil, masking flavor in people with Alcohol Drinking and Alcohol Use, Unspecified, run by Endourage, LLC at 1 site in United States.
Trial summary
This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Use, Unspecified, Alcohol Abstinence
- What is being tested?
- Endourage 1200 mg OMD ™ Oral Mucosal Drops, Isolate and Peppermint Oil, masking flavor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to 31 Jan 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older who can provide informed consent
- Ability to read and write in the English language and follow study-related procedures
- Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
- If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal)
Who cannot join
- Active illicit or non-prescribed drug use
- Concomitant use of benzodiazepines
- Concomitant use of Antabuse
- Documented history and active treatment for seizure disorder
- Transaminase elevation
- Hepatitis C infection (currently on therapy and/or any transaminitis elevation)
Show all 9Show fewer
- Hepatitis B infection (currently on therapy and/or any transaminitis elevation)
- Any form of mental impairment that will/could hinder safe participation in the study
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post Marketing Study to Evaluate the Safety and Efficacy of Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.
Read the detailed description
CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some evidence suggesting that it might have anti-anxiety, anticonvulsant, anti-inflammatory and immune boosting, antioxidant effects.
Currently, the only CBD product approved by the Food and Drug Administration is a prescription oil called Epidiolex (Greenwich Biosciences, Inc. 2018). It is approved to treat two types of epilepsy. Aside from Epidiolex, state laws on the use of CBD vary. While CBD is being studied as a treatment for a wide range of conditions, including Parkinson's disease, schizophrenia, diabetes, multiple sclerosis and anxiety, and addiction, research supporting the drug's benefits is still limited.
CBD use carries some risks. Though it is often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. CBD can also interact with other medications you are taking, such as blood thinners.
Another cause for concern is the unreliability of the purity and dosage of CBD in products. A recent study of 84 CBD products bought online showed that more than a quarter of the products contained less CBD than labeled. In addition, THC was found in 18 products. If you plan to use products containing CBD, talk to your primary health care provider.
People take cannabidiol by mouth for anxiety, bipolar disorder, a muscle disorder called dystonia, seizures, multiple sclerosis, Parkinson's disease, and schizophrenia.
Cannabidiol is possibly safe when taken by mouth and appropriately in adults. Cannabidiol doses of up to 300 mg daily have been used safely for up to 6 months. Higher doses of 1200-1500 mg daily have been used safely for up to 4 weeks. Cannabidiol sprays used under the tongue have been used in doses of 2.5 mg for up to 2 weeks.
- Being tested
- Endourage 1200 mg OMD ™ Oral Mucosal Drops, Isolate, Placebo, Peppermint Oil, masking flavor
- Medical subject headings
- Alcohol Drinking, Alcohol Abstinence, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endourage 1200 mg OMD ™ Oral Mucosal DropsDietary supplement
Also called OMD-1200, OMD 1200, Endourage OMD 1200
The CBD/THC ratio of OMD 1200 is 14:1 and the CBD/Terpene ratio is 1:1. Each ¼ dropper contains 10.2 mg of CBD and 0.7 mg of THC. The total % THC is 0.28%. These ratios indicate that the product will not cause euphoria.
IsolateDietary supplement
The isolate formulation contains 0% cannabinoids (CBD 0.00%; CBDa 0.00%; detla 9 THC 0.00%; THCa 0.00%).
PlaceboOther
Total CBD = CBD + (CBD-A * 0.877). Total THC = THCA-A * 0.877 + Delta 9 THC, ND = <LOQ, T-Caryophyllene = Trans-Caryophyllene, <LOQ = Less Than Limit of Quantitation, QNS = Quantity Not Sufficient. (%) = Percent, (ppm) = Parts per Million, (ppb) = Parts per Billion, (μg/Kg) = Microgram per Kilogram, (mg/g) = Milligram per Gram, ppm = (μg/g), ppb = (μg/kg),
Peppermint Oil, masking flavorDietary supplement
Also called Peppermint Oil, Peppermint Oil, Natural
Mentha piperita Leaf /Stem Oil; Physical state: Liquid. Color: Colorless to pale yellow; Characteristic peppermint odor; Not dangerous goods.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Placebo | Placebo comparator | Placebo Isolate Placebo (Hemp seed oil and peppermint flavoring) Receives: Dietary Supplement: Isolate; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor |
| Group 2 Isolate Comparator | Active comparator | Isolate Placebo Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio]) Receives: Dietary Supplement: Isolate; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor |
| Group 3 Placebo Comparator | Placebo comparator | Placebo OMD Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring) Receives: Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor |
| Group 4 Experimental Placebo | Experimental | OMD Placebo Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring) Receives: Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops; Other: Placebo; Dietary Supplement: Peppermint Oil, masking flavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety scores
Generalized Anxiety Disorder (GAD-7), measure for anxiety. Baseline scores will be compared to scores at end of study across arms. Change in anxiety scores from baseline to end of study will be measured. Range from 0-4 for minimal; 5-9 mild; 10-14 moderate; 15-21 severe. Changes will be compared across arms. Increased scores will indicate that study product was not effective in decreasing symptoms measured (anxiety).
Measured: 112 days (4-months)
Depression scores
Patient Health Questionnaire (PHQ-9), measure for depression. Change in depression scores from baseline to end of study.
Total Score for Depression Severity will be compared across arms from baseline to end of study at 112-days.
Score ranges from:
1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. Increased scores indicate that study product is not effective in decreasing symptoms measured (depression).
Measured: 112 days (4-months)
Alcohol craving scores
The Alcohol Craving Questionnaire Short Form (ACQ-SF-R) will be compared from baseline to end of study.
Changes in craving score will be measured in each arm of study. Scores from 1-7 (strongly disagree to strongly agree) is measured across 12 items and 4 sub-scales ([1] compulsivity, [2] expectancy, [3] purposefulness, and [4] emotionality).
The sum of the raw scores for each factor will be calculated and compared from baseline to the end of study across arms.
Increased scores indicate that study product is not effective in reducing cravings for alcohol.
Measured: 112 days (4-months)
Secondary outcomes (1)
To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.
Daily diary of symptom(s), dose(s) of study product and alcohol use will be kept by participants.
Diary entries of symptoms, daily dose of study product and daily alcohol use will be measured and compared across study arms from baseline to end of study.
Measured: 112 days (4-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Why it stopped: Study has been placed on hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 112-day, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of Endourage 1200 mg Complete Spectrum Oral Mucosal Drops (OMD ™). A total of 32 study participants will be enrolled. Placebo (Hemp seed oil and peppermint flavoring) Isolate (CBD no terpenes Hemp seed oil \[slightly lower concentration of CBD ratio\]) Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endourage, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas P Young, PhD NP, Principal investigator, Michael D Steward, MD + Thomas P Young, PhD, NP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659278
- Sponsor's protocol ID
- CSP ENDO 401-2020
- Status last verified
- Aug 2025
- First submitted
- 3 Oct 2020
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable/none planned
Publications
Everitt BJ, Robbins TW. Neural systems of reinforcement for drug addiction: from actions to habits to compulsion. Nat Neurosci. 2005 Nov;8(11):1481-9. doi: 10.1038/nn1579.
PubMed 16251991Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
PubMed 12648025MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4.
PubMed 29307505Moreira FA, Lutz B. The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16.
PubMed 18422832Parsons LH, Hurd YL. Endocannabinoid signalling in reward and addiction. Nat Rev Neurosci. 2015 Oct;16(10):579-94. doi: 10.1038/nrn4004. Epub 2015 Sep 16.
PubMed 26373473Laviolette SR, Grace AA. The roles of cannabinoid and dopamine receptor systems in neural emotional learning circuits: implications for schizophrenia and addiction. Cell Mol Life Sci. 2006 Jul;63(14):1597-613. doi: 10.1007/s00018-006-6027-5.
PubMed 16699809
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Study to Evaluate the Safety and Efficacy of Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
- ClinicalTrials.gov ID
- NCT04659278
- Acronym / sponsor ID
- CSP ENDO 401-2020
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been placed on hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Endourage, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Dec 2020 (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.
This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.
Detailed description
CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some evidence suggesting that it might have anti-anxiety, anticonvulsant, anti-inflammatory and immune boosting, antioxidant effects.
Currently, the only CBD product approved by the Food and Drug Administration is a prescription oil called Epidiolex (Greenwich Biosciences, Inc. 2018). It is approved to treat two types of epilepsy. Aside from Epidiolex, state laws on the use of CBD vary. While CBD is being studied as a treatment for a wide range of conditions, including Parkinson's disease, schizophrenia, diabetes, multiple sclerosis and anxiety, and addiction, research supporting the drug's benefits is still limited.
CBD use carries some risks. Though it is often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. CBD can also interact with other medications you are taking, such as blood thinners.
Another cause for concern is the unreliability of the purity and dosage of CBD in products. A recent study of 84 CBD products bought online showed that more than a quarter of the products contained less CBD than labeled. In addition, THC was found in 18 products. If you plan to use products containing CBD, talk to your primary health care provider.
People take cannabidiol by mouth for anxiety, bipolar disorder, a muscle disorder called dystonia, seizures, multiple sclerosis, Parkinson's disease, and schizophrenia.
Cannabidiol is possibly safe when taken by mouth and appropriately in adults. Cannabidiol doses of up to 300 mg daily have been used safely for up to 6 months. Higher doses of 1200-1500 mg daily have been used safely for up to 4 weeks. Cannabidiol sprays used under the tongue have been used in doses of 2.5 mg for up to 2 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a 112-day, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of Endourage 1200 mg Complete Spectrum Oral Mucosal Drops (OMD ™). A total of 32 study participants will be enrolled. Placebo (Hemp seed oil and peppermint flavoring) Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio]) Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)
| Arm | Type | Receives |
|---|---|---|
| Group 1 Placebo | Placebo comparator | Dietary Supplement: Isolate, Other: Placebo, Dietary Supplement: Peppermint Oil, masking flavorPlacebo Isolate Placebo (Hemp seed oil and peppermint flavoring) |
| Group 2 Isolate Comparator | Active comparator | Dietary Supplement: Isolate, Other: Placebo, Dietary Supplement: Peppermint Oil, masking flavorIsolate Placebo Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio]) |
| Group 3 Placebo Comparator | Placebo comparator | Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops, Other: Placebo, Dietary Supplement: Peppermint Oil, masking flavorPlacebo OMD Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring) |
| Group 4 Experimental Placebo | Experimental | Dietary Supplement: Endourage 1200 mg OMD ™ Oral Mucosal Drops, Other: Placebo, Dietary Supplement: Peppermint Oil, masking flavorOMD Placebo Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years of age or older who can provide informed consent
- Ability to read and write in the English language and follow study-related procedures
- Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
- If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal)
Key exclusion criteria (9 listed)
- Active illicit or non-prescribed drug use
- Concomitant use of benzodiazepines
- Concomitant use of Antabuse
- Documented history and active treatment for seizure disorder
- Transaminase elevation
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 |
|---|---|---|
| Endourage 1200 mg OMD ™ Oral Mucosal DropsAlso: OMD-1200, OMD 1200, Endourage OMD 1200The CBD/THC ratio of OMD 1200 is 14:1 and the CBD/Terpene ratio is 1:1. Each ¼ dropper contains 10.2 mg of CBD and 0.7 mg of THC. The total % THC is 0.28%. These ratios indicate that the product will not cause euphoria. | Dietary supplement | Group 3 Placebo Comparator, Group 4 Experimental Placebo |
| IsolateThe isolate formulation contains 0% cannabinoids (CBD 0.00%; CBDa 0.00%; detla 9 THC 0.00%; THCa 0.00%). | Dietary supplement | Group 1 Placebo, Group 2 Isolate Comparator |
| PlaceboTotal CBD = CBD + (CBD-A * 0.877). Total THC = THCA-A * 0.877 + Delta 9 THC, ND = <LOQ, T-Caryophyllene = Trans-Caryophyllene, <LOQ = Less Than Limit of Quantitation, QNS = Quantity Not Sufficient. (%) = Percent, (ppm) = Parts per Million, (ppb) = Parts per Billion, (μg/Kg) = Microgram per Kilogram, (mg/g) = Milligram per Gram, ppm = (μg/g), ppb = (μg/kg), | Other | Group 1 Placebo, Group 2 Isolate Comparator, Group 3 Placebo Comparator, Group 4 Experimental Placebo |
| Peppermint Oil, masking flavorAlso: Peppermint Oil, Peppermint Oil, NaturalMentha piperita Leaf /Stem Oil; Physical state: Liquid. Color: Colorless to pale yellow; Characteristic peppermint odor; Not dangerous goods. | Dietary supplement | Group 1 Placebo, Group 2 Isolate Comparator, Group 3 Placebo Comparator, Group 4 Experimental Placebo |
Primary outcome
Anxiety scores
Time frame: 112 days (4-months)
Generalized Anxiety Disorder (GAD-7), measure for anxiety. Baseline scores will be compared to scores at end of study across arms. Change in anxiety scores from baseline to end of study will be measured. Range from 0-4 for minimal; 5-9 mild; 10-14 moderate; 15-21 severe. Changes will be compared across arms. Increased scores will indicate that study product was not effective in decreasing symptoms measured (anxiety).
Depression scores
Time frame: 112 days (4-months)
Patient Health Questionnaire (PHQ-9), measure for depression. Change in depression scores from baseline to end of study. Total Score for Depression Severity will be compared across arms from baseline to end of study at 112-days. Score ranges from: 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression. Increased scores indicate that study product is not effective in decreasing symptoms measured (depression).
Alcohol craving scores
Time frame: 112 days (4-months)
The Alcohol Craving Questionnaire Short Form (ACQ-SF-R) will be compared from baseline to end of study. Changes in craving score will be measured in each arm of study. Scores from 1-7 (strongly disagree to strongly agree) is measured across 12 items and 4 sub-scales ([1] compulsivity, [2] expectancy, [3] purposefulness, and [4] emotionality). The sum of the raw scores for each factor will be calculated and compared from baseline to the end of study across arms. Increased scores indicate that study product is not effective in reducing cravings for alcohol.
1 secondary outcome
To determine CBDs impact on anxiety, depression, and alcohol craving that trigger desires to consume alcohol versus abstain.
Time frame: 112 days (4-months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Results publication: PubMed 16251991Everitt BJ, Robbins TW. Neural systems of reinforcement for drug addiction: from actions to habits to compulsion. Nat Neurosci. 2005 Nov;8(11):1481-9. doi: 10.1038/nn1579.
- Results publication: PubMed 12648025Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
- Results publication: PubMed 29307505MacCallum CA, Russo EB. Practical considerations in medical cannabis administration and dosing. Eur J Intern Med. 2018 Mar;49:12-19. doi: 10.1016/j.ejim.2018.01.004. Epub 2018 Jan 4.
- Results publication: PubMed 18422832Moreira FA, Lutz B. The endocannabinoid system: emotion, learning and addiction. Addict Biol. 2008 Jun;13(2):196-212. doi: 10.1111/j.1369-1600.2008.00104.x. Epub 2008 Apr 16.
- Results publication: PubMed 26373473Parsons LH, Hurd YL. Endocannabinoid signalling in reward and addiction. Nat Rev Neurosci. 2015 Oct;16(10):579-94. doi: 10.1038/nrn4004. Epub 2015 Sep 16.
- Results publication: PubMed 16699809Laviolette SR, Grace AA. The roles of cannabinoid and dopamine receptor systems in neural emotional learning circuits: implications for schizophrenia and addiction. Cell Mol Life Sci. 2006 Jul;63(14):1597-613. doi: 10.1007/s00018-006-6027-5.
- Background and summary of legislative Bill on HEMP production and cannabidiol (CBD)Link provided by the sponsor.
- CannMed promotes understanding of cannabis' complex science and its medical benefits for patients in need. Since its founding, cannabis researchers \& industry leaders collaborates with CannMed to announce their latest findings.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable/none planned
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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.
Thomas P Young, PhD NP principal investigator
Michael D Steward, MD + Thomas P Young, PhD, NP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endourage 1200 mg OMD ™ Oral Mucosal Drops, Isolate and Peppermint Oil, masking flavor in people with Alcohol Drinking and Alcohol Use, Unspecified, run by Endourage, LLC 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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 7 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. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Anxiety scores (time frame: 112 days (4-months)). The study lists 3 primary outcomes in all. 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 NCT04659278, which also lists 6 linked publications.
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 7 Aug 2025.