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Psychedelic
Psilocybin-Enhanced Psychotherapy for Methamphetamine Addiction
Phase 1 & 2
Recruiting
Led By Chris Stauffer, MD
Research Sponsored by Portland VA Research Foundation, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Awards & highlights
Study Summary
This trial is testing whether psilocybin, a drug found in magic mushrooms, can help people with methamphetamine addiction.
Who is the study for?
This trial is for individuals with moderate to severe methamphetamine use disorder who want to stop or cut down on their use. It's not suitable for those with uncontrolled high blood pressure, significant heart disease, seizures in adulthood, poorly controlled diabetes, certain medication regimes, bipolar I disorder, active eating disorders with purging behaviors, persistent psychotic disorders (like schizophrenia), hallucinogen use disorder, or those who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The study is testing if psilocybin-enhanced psychotherapy can help people with methamphetamine addiction better than the usual treatment methods. Participants will be randomly assigned to receive either the new therapy involving psilocybin or continue with standard treatments without it.See study design
What are the potential side effects?
Psilocybin may cause temporary changes in perception and mood during administration. Other potential side effects include nausea and headache. Psychological support is provided during sessions to manage any discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability
Proportion of patients who complete the intervention and follow-up
Secondary outcome measures
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up
Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
+3 moreOther outcome measures
Change from baseline in Anxiety Symptoms at 180 day post-discharge follow-up
Change from baseline in Anxiety Symptoms at 60 day post-discharge follow-up
Anxiety
+14 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment-as-UsualExperimental Treatment1 Intervention
Treatment-as-usual while admitted to a residential rehabilitation treatment program.
Group II: Psilocybin-enhanced psychotherapyExperimental Treatment2 Interventions
Psilocybin will be administered twice (25mg & 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment-as-usual
2020
Completed Phase 3
~900
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
Portland VA Research Foundation, IncLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Steven & Alexandra Cohen FoundationOTHER
6 Previous Clinical Trials
194 Total Patients Enrolled
Chris Stauffer, MDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
48 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had seizures as an adult.I am not on medications that interact with psilocybin.I have cancer spread to my brain or a brain infection with symptoms.I have high blood pressure or heart problems that aren't well-managed.My diabetes is not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin-enhanced psychotherapy
- Group 2: Treatment-as-Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Amphetamine Use Disorder Patient Testimony for trial: Trial Name: NCT04982796 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity for participants to join this trial?
"As per the information on clinicaltrials.gov, this experiment is still enrolling participants. It was initially announced on July 7th 2022 and has been recently amended as of July 12th 2022."
Answered by AI
What is the current number of participants in this clinical research endeavor?
"Affirmative. According to clinicaltrials.gov, the research trial was first posed on July 7th 2022 and is presently seeking out participants. In total, 30 individuals are required at a single site for successful completion of this study."
Answered by AI
Have other researchers conducted investigations on Psilocybin's effects?
"At the moment, there are 32 studies that involve psilocybin. None of these trials have reached phase 3 yet. Most investigations into this treatment occur in Vancouver, Washington but they span across 35 distinct medical centres."
Answered by AI
Are there any qualifications that must be met to participate in this research?
"To be eligible for this experiment, applicants should have a history of amphetamine abuse and fall between the ages of 25-65. Approximately 30 individuals will be selected to participate."
Answered by AI
What is the ultimate goal of this medical experiment?
"The primary aim of this trial is to gauge its acceptability among participants, with secondary objectives including the assessment of safety (as defined by FDA regulations), changes in functional impairment as measured by Sheehan Disability Scale at 60 days post-discharge follow-up and average methamphetamine use over a four week period. This study will be conducted through an 6 week intervention and 180 day follow up."
Answered by AI
Does this clinical research accept participants over the age of 20?
"This research trial is exclusively for adult participants, who must fall between the ages of 25 and 65. There are 1 studies dedicated to those under 18 and 36 specifically tailored for seniors above 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Other
Oregon
California
How old are they?
18 - 65
What site did they apply to?
Portland VA Health Care System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
1
Why did patients apply to this trial?
I want to stop meth. I have been a user and would like to quit. I have a deep fear of pharmaceuticals. I know I must be hypocritical, using meth & fearing pharmaceuticals.
PatientReceived 2+ prior treatments
Have struggled with this issue and other mental health/addiction issues for many years now, tried regular therapy and many medications to no avail.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
What is the variety of cubensis Mushrooms are you using and why fid you pick that one?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Portland VA Health Care System: < 24 hours
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