Major DepressionPhase 1NCT05894902
Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
A Phase 1 study testing SM-001 in people with Major Depression and Post Traumatic Stress Disorder, run by Advanced Integrative Medical Science Institute at 1 site in United States.
Trial summary
Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression, Post Traumatic Stress Disorder
- What is being tested?
- SM-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jun 2024
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults: men and women ages 25-65 years of age
- Previous experience with a psychedelic drug
- Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate
- Normal blood pressure (for age) in the absence of antihypertensive drugs
- Normal complete blood count and differential, platelets, coagulation ((PT/PTT)
- Liver function tests ≤ 1.5X upper limits of normal
Show all 11Show fewer
- Renal function (BUN, serum Creatinine) - within normal limits
- Able to understand and willing to comply with Study Protocol requirements.
- Willing to abstain from alcohol for at least 72 hours prior to and following Study Day 0
- No use of recreational drugs for at least 14 days prior to Study Day 0.
- Women who are not pregnant or lactating.
Who cannot join
- Body Mass Index > 30 or < 20
- Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters.
- History of seizures
- History of drug or alcohol abuse
- History of psychiatric disorder or history of significant trauma, as defined by DSM- V.
- Use of SSRIs, MAO inhibitors, or other psychoactive compounds either pharmaceutical drugs or botanical in origin (i.e., 5-HTP, St John's Wort)
- Any condition which, in the opinion of the Investigators, would preclude the use of the test article or the successful completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
AIMS Institute
Seattle, Washington, 98102
Michelle Speaks, MBA, 206-420-1321, mspeaks@aimsinstitute.net
Sunil K Aggarwal, MD, PhD, 2064201321, saggarwal@aimsinstitute.net
About this study
Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers
Read the detailed description
The Investigational New Drug SM-001 is formulated as a hot water decoction of two clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). It represents a modern formulation of an ancient Amazonian botanical medicine, "ayahuasca" ("vine of the soul") that is used by many native South American indigenous and mestizo groups for both religious and medicinal purposes.
This initial Phase 1 study is to be conducted as an open label, dose-ranging safety assessment of a single dose of SM-001 taken orally by healthy adult volunteers. Twelve adult men and women, ages 25-65 years, will be consecutively assigned to one of three dose levels, 4 subjects per group (2 M; 2 F). In the presence of the Clinical Investigator(s), each subject will receive a single dose of SM-001, administered at the Clinical Study Site as a liquid at one of three dose levels: 0.25, 0.5, or1.5 ml SM-001 per kg body weight. To assess systemic exposure to SM-001, plasma levels of the four biomarkers, dimethyltryptamine, harmine, tetrahydroharmine, and harmaline will be measured. Blood samples will be drawn at baseline, HR 0 (pre-Study Drug dose), and then at HR 1, 2, 4, 8, and 24 post dose. Subjects will return to the Clinical Study Site at Study Day 28 for a final in-person assessment.
- Conditions
- Major Depression, Post Traumatic Stress Disorder
- Being tested
- SM-001
- Keywords
- Banisteriopsis caapi, Psychotria viridis, ayahuasca, ethnomedicine, N,N-dimethyltryptamine (DMT), harmine (HAR), harmaline, tetrahydroharmine
- Medical subject headings
- Depressive Disorder, Major, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-001Drug
Also called Ayahuasca
The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).
| Study group | Role | What they receive |
|---|---|---|
| Open label Phase I safety & dose finding study: low dose group | Active comparator | 4 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001 Receives: Drug: SM-001 |
| Open label Phase I safety & dose finding study: medium dose group | Active comparator | 4 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001 Receives: Drug: SM-001 |
| Open label Phase I safety & dose finding study: high dose group | Active comparator | 4 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001 Receives: Drug: SM-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
To evaluate safety and tolerability of SM-001 in healthy adults following a single oral dose, at one of three different dose levels. The Incidence of Treatment-Emergent Adverse Events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE).
Percentage of participants with at least one safety event [Time Frame: Baseline up to Day 28 ] Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments and physical examination findings.
Measured: 1-28 days
Secondary outcomes (5)
Short-term psychological impact
To assess short-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Hallucinogenic Rating Scale 24 hours after the single experimental drug session. This is an 85 item questionnaire with each item rated 0-4 with a maximum score of 340. A higher score correlates with a more intense psychological experience.
Measured: 24 hours after single drug session
Longer-term psychological impact
To assess longer-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Persisting Effects Questionnaire 7 days following the single experimental drug session.
The Persisting Effects Questionnaire includes 140 of the items that are rated on a 6-point scale (0=none, not at all; 1=so slight cannot decide; 2=slight; 3=moderate; 4=strong; 5=extreme, more than ever before in your life and stronger than 4).
Measured: Day 7 after a single drug session
Bioavailability of SM-001
To determine the blood, urine and feces levels of plant alkaloids including dimethyltryptamine, harmine, tetrahydroharmine and harmaline in ng/mL following a single oral dose of SM-001.
Measured: Day 1-2
Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor
Brain Derived Neurotrophic Factor will be quantitated (ng/mL) is each study subject's blood on the day before and the day after the SM-001 drug session.
Measured: Day 1-28
Effects of a single dose of SM-001 on blood cortisol blood levels
Cortisol levels in each study subject's blood will be measured (mg/mL)
Measured: Day 1 - 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Subjects will be consecutively accrued to one of three study groups, starting at the lowest dose, Level 1 ("low" dose), and proceeding to the next higher dose level. Each subject will receive one dose of the Study Drug orally at the Clinical Study Site, according to their assigned dose Level. Dose levels vary by volume: Level 1: 0.5 mL/kg ("low"; 50% of usual dose) N=4 (2M/2F) Level 2: 1 ml/kg ("medium"; 100% of usual dose) N=4 (2M/2F) Level 3: 2 ml/kg ("high"; 200% of usual dose) N=4 (2M/2F)
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced Integrative Medical Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leanna J Standish, ND PhD, Principal investigator, AIMS Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894902
- Sponsor's protocol ID
- SM-001
- Status last verified
- Jun 2023
- First submitted
- 15 Mar 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aarons DH, Rossi GV, Orzechowski RF. Cardiovascular actions of three harmala alkaloids: harmine, harmaline, and harmalol. J Pharm Sci. 1977 Sep;66(9):1244-8. doi: 10.1002/jps.2600660910.
PubMed 903860Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.
PubMed 26442957Brown CS, Bryant SG. Monoamine oxidase inhibitors: safety and efficacy issues. Drug Intell Clin Pharm. 1988 Mar;22(3):232-5. doi: 10.1177/106002808802200311.
PubMed 3284731Hamill J, Hallak J, Dursun SM, Baker G. Ayahuasca: Psychological and Physiologic Effects, Pharmacology and Potential Uses in Addiction and Mental Illness. Curr Neuropharmacol. 2019;17(2):108-128. doi: 10.2174/1570159X16666180125095902.
PubMed 29366418Callaway JC, Raymon LP, Hearn WL, McKenna DJ, Grob CS, Brito GS, Mash DC. Quantitation of N,N-dimethyltryptamine and harmala alkaloids in human plasma after oral dosing with ayahuasca. J Anal Toxicol. 1996 Oct;20(6):492-7. doi: 10.1093/jat/20.6.492.
PubMed 8889686Da Prada M, Zurcher G, Wuthrich I, Haefely WE. On tyramine, food, beverages and the reversible MAO inhibitor moclobemide. J Neural Transm Suppl. 1988;26:31-56.
PubMed 3283290dos Santos RG. Safety and side effects of ayahuasca in humans--an overview focusing on developmental toxicology. J Psychoactive Drugs. 2013 Jan-Mar;45(1):68-78. doi: 10.1080/02791072.2013.763564.
PubMed 23662333Dos Santos RG, Grasa E, Valle M, Ballester MR, Bouso JC, Nomdedeu JF, Homs R, Barbanoj MJ, Riba J. Pharmacology of ayahuasca administered in two repeated doses. Psychopharmacology (Berl). 2012 Feb;219(4):1039-53. doi: 10.1007/s00213-011-2434-x. Epub 2011 Aug 13.
PubMed 21842159Santos RG, Landeira-Fernandez J, Strassman RJ, Motta V, Cruz AP. Effects of ayahuasca on psychometric measures of anxiety, panic-like and hopelessness in Santo Daime members. J Ethnopharmacol. 2007 Jul 25;112(3):507-13. doi: 10.1016/j.jep.2007.04.012. Epub 2007 Apr 25.
PubMed 17532158Dominguez-Clave E, Soler J, Elices M, Pascual JC, Alvarez E, de la Fuente Revenga M, Friedlander P, Feilding A, Riba J. Ayahuasca: Pharmacology, neuroscience and therapeutic potential. Brain Res Bull. 2016 Sep;126(Pt 1):89-101. doi: 10.1016/j.brainresbull.2016.03.002. Epub 2016 Mar 11.
PubMed 26976063Gable RS. Risk assessment of ritual use of oral dimethyltryptamine (DMT) and harmala alkaloids. Addiction. 2007 Jan;102(1):24-34. doi: 10.1111/j.1360-0443.2006.01652.x.
PubMed 17207120Gillin JC, Tinklenberg J, Stoff DM, Stillman R, Shortlidge JS, Wyatt RJ. 5-Methoxy-N,N-dimethyltryptamine: behavioral and toxicological effects in animals. Biol Psychiatry. 1976 Jun;11(3):355-8. No abstract available.
PubMed 820383Griffiths R, Richards W, Johnson M, McCann U, Jesse R. Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later. J Psychopharmacol. 2008 Aug;22(6):621-32. doi: 10.1177/0269881108094300. Epub 2008 Jul 1.
PubMed 18593735Grob CS, McKenna DJ, Callaway JC, Brito GS, Neves ES, Oberlaender G, Saide OL, Labigalini E, Tacla C, Miranda CT, Strassman RJ, Boone KB. Human psychopharmacology of hoasca, a plant hallucinogen used in ritual context in Brazil. J Nerv Ment Dis. 1996 Feb;184(2):86-94. doi: 10.1097/00005053-199602000-00004.
PubMed 8596116Kamel SH, Ibrahim TM, Hamza SM. Effect of harmine and harmaline hydrochloride on pregnancy in white rats. Zentralbl Veterinarmed A. 1971 May;18(3):230-3. doi: 10.1111/j.1439-0442.1971.tb00573.x. No abstract available.
PubMed 4997511
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults
- ClinicalTrials.gov ID
- NCT05894902
- Acronym / sponsor ID
- SM-001
- Conditions
- Major Depression, Post Traumatic Stress Disorder
- Keywords
- Banisteriopsis caapi, Psychotria viridis, ayahuasca, ethnomedicine, N,N-dimethyltryptamine (DMT), harmine (HAR), harmaline, tetrahydroharmine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Advanced Integrative Medical Science InstituteUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Jun 2023 (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.
Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers
Detailed description
The Investigational New Drug SM-001 is formulated as a hot water decoction of two clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). It represents a modern formulation of an ancient Amazonian botanical medicine, "ayahuasca" ("vine of the soul") that is used by many native South American indigenous and mestizo groups for both religious and medicinal purposes.
This initial Phase 1 study is to be conducted as an open label, dose-ranging safety assessment of a single dose of SM-001 taken orally by healthy adult volunteers. Twelve adult men and women, ages 25-65 years, will be consecutively assigned to one of three dose levels, 4 subjects per group (2 M; 2 F). In the presence of the Clinical Investigator(s), each subject will receive a single dose of SM-001, administered at the Clinical Study Site as a liquid at one of three dose levels: 0.25, 0.5, or1.5 ml SM-001 per kg body weight. To assess systemic exposure to SM-001, plasma levels of the four biomarkers, dimethyltryptamine, harmine, tetrahydroharmine, and harmaline will be measured. Blood samples will be drawn at baseline, HR 0 (pre-Study Drug dose), and then at HR 1, 2, 4, 8, and 24 post dose. Subjects will return to the Clinical Study Site at Study Day 28 for a final in-person assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be consecutively accrued to one of three study groups, starting at the lowest dose, Level 1 ("low" dose), and proceeding to the next higher dose level. Each subject will receive one dose of the Study Drug orally at the Clinical Study Site, according to their assigned dose Level. Dose levels vary by volume: Level 1: 0.5 mL/kg ("low"; 50% of usual dose) N=4 (2M/2F) Level 2: 1 ml/kg ("medium"; 100% of usual dose) N=4 (2M/2F) Level 3: 2 ml/kg ("high"; 200% of usual dose) N=4 (2M/2F)
| Arm | Type | Receives |
|---|---|---|
| Open label Phase I safety & dose finding study: low dose group | Active comparator | Drug: SM-0014 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001 |
| Open label Phase I safety & dose finding study: medium dose group | Active comparator | Drug: SM-0014 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001 |
| Open label Phase I safety & dose finding study: high dose group | Active comparator | Drug: SM-0014 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy adults: men and women ages 25-65 years of age
- Previous experience with a psychedelic drug
- Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate
- Normal blood pressure (for age) in the absence of antihypertensive drugs
- Normal complete blood count and differential, platelets, coagulation ((PT/PTT)
Key exclusion criteria (7 listed)
- Body Mass Index > 30 or < 20
- Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters.
- History of seizures
- History of drug or alcohol abuse
- History of psychiatric disorder or history of significant trauma, as defined by DSM- V.
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 |
|---|---|---|
| SM-001Also: AyahuascaThe Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). | Drug | Open label Phase I safety & dose finding study: high dose group, Open label Phase I safety & dose finding study: low dose group, Open label Phase I safety & dose finding study: medium dose group |
Primary outcome
Primary Objective
Time frame: 1-28 days
To evaluate safety and tolerability of SM-001 in healthy adults following a single oral dose, at one of three different dose levels. The Incidence of Treatment-Emergent Adverse Events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE). Percentage of participants with at least one safety event [Time Frame: Baseline up to Day 28 ] Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments and physical examination findings.
5 secondary outcomes
Short-term psychological impact
Time frame: 24 hours after single drug session
Longer-term psychological impact
Time frame: Day 7 after a single drug session
Bioavailability of SM-001
Time frame: Day 1-2
Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor
Time frame: Day 1-28
Effects of a single dose of SM-001 on blood cortisol blood levels
Time frame: Day 1 - 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 903860Aarons DH, Rossi GV, Orzechowski RF. Cardiovascular actions of three harmala alkaloids: harmine, harmaline, and harmalol. J Pharm Sci. 1977 Sep;66(9):1244-8. doi: 10.1002/jps.2600660910.
- Background: PubMed 26442957Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177/0269881115609019. Epub 2015 Oct 6.
- Background: PubMed 3284731Brown CS, Bryant SG. Monoamine oxidase inhibitors: safety and efficacy issues. Drug Intell Clin Pharm. 1988 Mar;22(3):232-5. doi: 10.1177/106002808802200311.
- Background: PubMed 29366418Hamill J, Hallak J, Dursun SM, Baker G. Ayahuasca: Psychological and Physiologic Effects, Pharmacology and Potential Uses in Addiction and Mental Illness. Curr Neuropharmacol. 2019;17(2):108-128. doi: 10.2174/1570159X16666180125095902.
- Background: PubMed 8889686Callaway JC, Raymon LP, Hearn WL, McKenna DJ, Grob CS, Brito GS, Mash DC. Quantitation of N,N-dimethyltryptamine and harmala alkaloids in human plasma after oral dosing with ayahuasca. J Anal Toxicol. 1996 Oct;20(6):492-7. doi: 10.1093/jat/20.6.492.
- Background: PubMed 3283290Da Prada M, Zurcher G, Wuthrich I, Haefely WE. On tyramine, food, beverages and the reversible MAO inhibitor moclobemide. J Neural Transm Suppl. 1988;26:31-56.
- Background: PubMed 23662333dos Santos RG. Safety and side effects of ayahuasca in humans--an overview focusing on developmental toxicology. J Psychoactive Drugs. 2013 Jan-Mar;45(1):68-78. doi: 10.1080/02791072.2013.763564.
- Background: PubMed 21842159Dos Santos RG, Grasa E, Valle M, Ballester MR, Bouso JC, Nomdedeu JF, Homs R, Barbanoj MJ, Riba J. Pharmacology of ayahuasca administered in two repeated doses. Psychopharmacology (Berl). 2012 Feb;219(4):1039-53. doi: 10.1007/s00213-011-2434-x. Epub 2011 Aug 13.
- Background: PubMed 17532158Santos RG, Landeira-Fernandez J, Strassman RJ, Motta V, Cruz AP. Effects of ayahuasca on psychometric measures of anxiety, panic-like and hopelessness in Santo Daime members. J Ethnopharmacol. 2007 Jul 25;112(3):507-13. doi: 10.1016/j.jep.2007.04.012. Epub 2007 Apr 25.
- Background: PubMed 26976063Dominguez-Clave E, Soler J, Elices M, Pascual JC, Alvarez E, de la Fuente Revenga M, Friedlander P, Feilding A, Riba J. Ayahuasca: Pharmacology, neuroscience and therapeutic potential. Brain Res Bull. 2016 Sep;126(Pt 1):89-101. doi: 10.1016/j.brainresbull.2016.03.002. Epub 2016 Mar 11.
- Background: PubMed 17207120Gable RS. Risk assessment of ritual use of oral dimethyltryptamine (DMT) and harmala alkaloids. Addiction. 2007 Jan;102(1):24-34. doi: 10.1111/j.1360-0443.2006.01652.x.
- Background: PubMed 820383Gillin JC, Tinklenberg J, Stoff DM, Stillman R, Shortlidge JS, Wyatt RJ. 5-Methoxy-N,N-dimethyltryptamine: behavioral and toxicological effects in animals. Biol Psychiatry. 1976 Jun;11(3):355-8. No abstract available.
- 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.
Leanna J Standish, ND PhD principal investigator
AIMS Institute
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 SM-001 in people with Major Depression and Post Traumatic Stress Disorder, run by Advanced Integrative Medical Science Institute 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 11 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: status not confirmed, as of the sponsor's last update on 7 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leanna J Standish, ND PhD (2064201321, Lstandish@aimsinstitute.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 1-28 days). 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 NCT05894902, which also lists 36 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 Jul 2023.