Trauma for Traumatic Brain Injury (TBI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Traumatic Brain Injury (TBI)Trauma - Drug
Eligibility
21 - 99
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether psilocybin can help people with chronic illnesses who are also experiencing unregulated trauma.

Eligible Conditions
  • Traumatic Brain Injury (TBI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 8 weeks

8 weeks
BAM Score
GAF Score
PLC-5 Score

Trial Safety

Side Effects for

Diphenhydramine
9%Nausea
7%Viral upper resp. tract infection
7%Pain
7%Bronchitis
7%Back pain
4%Suicidal Ideation
4%Diarrhea
4%Depressed mood
4%Influenza
4%Headache
4%Sinus headache
4%Alcohol withdrawal syndrome
4%Depression
4%Insomnia
4%Lower resp. tract congestion
4%Oropharyngeal pain
2%Migraine
2%Oedema
2%Bronchitis bacterial
2%Constipation
2%Hypoesthesia
2%Pyrexia
2%Influenza like Illness
2%Anger
2%Peripheral swelling
2%Mallory-Weiss Syndrom
2%Anemia
2%Thrombocytosis
2%Vomiting
2%Dermatitis contact
2%Eye infection
2%Fungal infection
2%Gingivitis
2%Traumatic lung injury
2%Hyponatremia
2%Arthralgia
2%Musculoskeletal pain
2%Pain in extremity
2%Malignant melanoma
2%Dizziness
2%Sedation
2%Anxiety
2%Restlessness
2%Cough
2%Rhinorrhea
2%Sinus congestion
2%Sexual abuse
2%Arthoscopic surgery
2%Endodontic procedure
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Diphenhydramine ARM group. Side effects include: Nausea with 9%, Viral upper resp. tract infection with 7%, Pain with 7%, Bronchitis with 7%, Back pain with 7%.

Trial Design

4 Treatment Groups

Participant
1 of 4
Psychiatrist
1 of 4
Plant Medicine On Boarding
1 of 4
On-Boarding Plant Medicine Specialist
1 of 4

Experimental Treatment

30 Total Participants · 4 Treatment Groups

Primary Treatment: Trauma · No Placebo Group · Phase 1

Participant
Drug
Experimental Group · 1 Intervention: Trauma · Intervention Types: Drug
Psychiatrist
Drug
Experimental Group · 1 Intervention: Trauma · Intervention Types: Drug
Plant Medicine On Boarding
Drug
Experimental Group · 1 Intervention: Trauma · Intervention Types: Drug
On-Boarding Plant Medicine Specialist
Drug
Experimental Group · 1 Intervention: Trauma · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

NWTraumatherapiesLead Sponsor
World Health OrganizationOTHER
222 Previous Clinical Trials
1,446,895 Total Patients Enrolled
Ross M Allison, ProviderStudy DirectorNW Therapies Trauma Unit

Eligibility Criteria

Age 21 - 99 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a physician, licensed clinical psychologist, licensed psychiatrist, licensed administrator, or licensed medical director of a psychiatric hospital.

Who else is applying?

What state do they live in?
Montana23.1%
Pennsylvania15.4%
New York7.7%
Other53.8%
How old are they?
18 - 6587.5%
65+12.5%
What site did they apply to?
Ross Allison NPI #1437519899 Administrator Of Study100.0%
What portion of applicants met pre-screening criteria?
Met criteria84.6%
Did not meet criteria15.4%
How many prior treatments have patients received?
033.3%
233.3%
3+33.3%
Why did patients apply to this trial?
  • "I have been researching safe methods of treating PTSD without harmful drugs. I have researched psilocybin and feel strong Lu that it may be helpful. After multiple therapies. That may be beneficial."
  • "I’m considering using psilocybin on my own. It is now decriminalized in Colorado. I would prefer to donate as a volunteer to legitimate medical research, and I would prefer the medical oversight of such activity. My career was involving biomedical research so I’m enthusiastic about learning and contributing."