Psychedelics for Emotional Numbness
(OAD1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how two different drugs, Psilocybin and Dextromethorphan (a common cough suppressant), affect brain activity and emotional numbness in older adults with low well-being. Researchers seek to determine if these drugs can alter brain patterns and reduce inflammation markers in the body. Participants will receive varying doses of the drugs to compare their effects. Individuals over the age of 50 who have felt emotionally flat or disengaged might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how these treatments work in people, offering participants the opportunity to be among the first to receive these innovative therapies.
Do I need to stop taking my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that psilocybin, when used in a controlled setting, can lead to strong emotional experiences. People often report feeling more connected and open. While most handle it well, risks exist. Some users have experienced temporary anxiety or confusion, especially with higher doses. Research suggests these effects usually don't last long.
Researchers are also studying dextromethorphan, a common ingredient in cough medicine. It's safe at regular doses, but higher amounts can cause problems like dizziness, confusion, or even hallucinations. Most side effects occur with large doses or when combined with other substances.
Both treatments remain in early testing stages for emotional numbness. As studies continue, more safety information will become available.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer a novel approach to tackling emotional numbness, a condition often managed with antidepressants or therapy. Unlike the standard options, which typically take weeks to show results, psilocybin and dextromethorphan potentially provide rapid relief through their unique mechanisms. Psilocybin, a psychedelic compound, targets serotonin receptors in the brain, possibly leading to increased emotional connectivity and awareness. Dextromethorphan, usually found in cough medicine, acts on the brain's NMDA receptors, offering a different pathway to potentially lift emotional numbness. These innovative approaches may pave the way for faster, more effective relief for those struggling with this condition.
What evidence suggests that this trial's treatments could be effective for emotional numbness?
Research has shown that psilocybin, one of the treatments in this trial, can significantly improve anxiety and depression symptoms over time. Some patients experience faster relief compared to traditional treatments. In one study, 57% of patients undergoing psilocybin-assisted therapy saw their symptoms disappear, a higher rate than those using other treatments. Psilocybin has also been compared to the antidepressant escitalopram and demonstrated similar effectiveness in improving mood over six months.
Dextromethorphan, another treatment option in this trial, has shown potential as an antidepressant, especially when combined with other substances. One study found that 80% of patients receiving dextromethorphan responded positively, with 53.3% experiencing significant symptom improvement. Another study found that dextromethorphan quickly reduced anxiety symptoms within a week for some patients. This trial explores both drugs for their potential to help with emotional numbness and related conditions.678910Are You a Good Fit for This Trial?
This trial is for adults aged 50-85 with low well-being, as measured by the WHO-5 index. They must be mentally sharp (MMSE score >24), willing to follow the study's procedures over its duration, and have a contact person available. Women must be post-menopausal or unable to become pregnant; men must use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of either Psilocybin or Dextromethorphan, with dosing visit lasting 8-12 hours
Follow-up
Participants are monitored for changes in EEG activity, neuroinflammation markers, and autonomic physiology
What Are the Treatments Tested in This Trial?
Interventions
- Dextromethorphan
- Psilocybin
Trial Overview
The study tests how Psilocybin and Dextromethorphan affect brain activity in older adults with low well-being. It examines changes in EEG complexity, neuroinflammation markers, autonomic physiology, and brain structure/function over three months with varying doses of each drug.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
A single moderate-to-high dose of Psilocybin (25-30 mg)
A single moderate-to-high dose of Dextromethorphan (80-90 mg)
A single low-to-moderate dose of Psilocybin (5-10 mg)
A single low-to-moderate dose of Dextromethorphan (30-60 mg)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Mitchell
Lead Sponsor
Citations
Evaluating the safety and efficacy of dextromethorphan ... - PMC
Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end point.
2.
researchgate.net
researchgate.net/publication/264247691_Evaluating_the_safety_and_efficacy_of_dextromethorphanquinidine_in_the_treatment_of_pseudobulbar_affect(PDF) Evaluating the safety and efficacy of ...
Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end ...
3.
scholarworks.indianapolis.iu.edu
scholarworks.indianapolis.iu.edu/bitstreams/a1be4e3b-14fc-432b-a385-d2b8bca59daa/downloadSafety, Tolerability, and Effectiveness of Dextromethorphan ...
PRISM II evaluated DM/Q effectiveness, safety and tolerability for PBA following stroke, dementia or traumatic brain injury (TBI). Objective. To report results ...
4.
pharmacytimes.com
pharmacytimes.com/view/dextromethorphan-emerges-as-a-novel-antidepressant-pathway-for-treatment-resistant-depressionDextromethorphan Emerges as a Novel Antidepressant ...
Patients receiving DXM also had a higher response rate (80% vs. 43.3%; p=0.008) and greater remission rate (53.3% vs. 16.7%; p=0.007). 17.
5.
psychiatryadvisor.com
psychiatryadvisor.com/reports/dextromethorphan-bupropion-efficacy-for-anxiety-and-major-depressive-disorder/Dextromethorphan-Bupropion Effective for Comorbid ...
Study authors concluded, “Response and remission from anxiety symptoms were achieved as early as 1 week after starting treatment with AXS-05.
Dextromethorphan Toxicity - StatPearls - NCBI Bookshelf
Depending on the dose and coingestants, dextromethorphan can cause a broad spectrum of clinical effects ranging from mild agitation to psychosis to seizures ...
Dextromethorphan/DXM Overdose: Dangers of Abusing ...
Symptoms of dextromethorphan intoxication include. Impaired motor function; Numbness; Dissociative episodes; Audio and visual hallucinations ...
6 Dextromethorphan Side Effects to Know
The maximum safe dose of dextromethorphan for adults is 120 mg per day. If ... Taking large amounts of dextromethorphan can create a “high” feeling.
9.
mayoclinic.org
mayoclinic.org/drugs-supplements/dextromethorphan-and-quinidine-oral-route/description/drg-20074618Dextromethorphan and quinidine (oral route) - Side effects ...
Dextromethorphan and quinidine combination is used to treat a rare condition called pseudobulbar affect (PBA) or emotional incontinence.
“Robo-Tripping”: Dextromethorphan Abuse and its Anesthetic ...
Chronic dextromethorphan abusers may suffer from symptoms of psychological withdrawal (2, 3, 12). Indeed, our patient described pronounced fatigue and depressed ...
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