What side effects are associated with this type of intervention?

Common treatments for methamphetamine addiction include mirtazapine, topiramate, and varenicline. Mirtazapine has been associated with increased anxiety and longer sleep duration. Topiramate can cause adverse effects such as impaired concentration, confusion, dizziness, anxiety, and paresthesias, leading to higher dropout rates. Varenicline may cause nausea, insomnia, and abnormal dreams. Psilocybin, a serotonin receptor agonist, is being studied for its safety and feasibility, with current evidence suggesting it is well-tolerated with no severe adverse events reported in small sample studies.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of methamphetamine addiction. The context mentions a study investigating the safety and feasibility of psilocybin, a serotonin receptor agonist, for methamphetamine use disorder, but it does not indicate any prior FDA approvals for similar treatments. Other psychostimulants and medications have been studied for substance use disorders, but none have received FDA approval for methamphetamine addiction.

What other types of research exist?

Promising novel alternatives to psilocybin for methamphetamine addiction include: 1) M100907, a serotonin 2A antagonist, which has shown potential in reducing methamphetamine self-administration in preclinical studies. 2) WAY163909, a serotonin 2C agonist, which has also demonstrated efficacy in reducing methamphetamine use in preclinical trials. 3) Traditional Korean herbal medicine PAP 9704, which has been found to attenuate methamphetamine-induced hyperlocomotion in animal models. These alternatives are still under investigation but show potential for future treatment options.

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Psychedelic

Psilocybin for Methamphetamine Addiction

Phase 1

Recruiting

Led By Christopher Nicholas, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of heart transplant or stroke

Current use of and inability or unwillingness to taper off of medications that may interact with psilocybin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 weeks

Awards & highlights

Summary

This trial tests if psilocybin pills, combined with counseling, are safe for adults addicted to methamphetamine. Psilocybin can change brain function temporarily, helping people see their addiction differently. Counseling supports participants in understanding and using these new insights to aid their recovery. Psilocybin has shown potential in treating addiction, including nicotine and alcohol addiction, and has been studied for its effects on depression and anxiety.

Who is the study for?

This trial is for adults with methamphetamine use disorder who've used meth less than 16 days in the past month. It's not for those with insulin-dependent diabetes, pregnant individuals, untreated high blood pressure, a history of heart transplant or stroke, current severe heart issues, or those on certain medications.

What is being tested?

The study tests the safety and practicality of two oral doses of psilocybin alongside behavioral support over approximately six months. Psilocybin is given to see if it can help people with methamphetamine addiction.

What are the potential side effects?

Psilocybin may cause psychological effects like changes in perception, mood swings, and altered sense of time. Physical side effects could include headaches, dizziness, nausea or increased heart rate.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a heart transplant or a stroke.

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I am using medications that cannot be mixed with psilocybin and cannot stop.

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I am currently experiencing heart-related chest pain.

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My blood pressure is often above 140/90 mmHg.

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I am currently dependent on insulin for my diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of serious adverse events associated with oral psilocybin

Secondary study objectives

Changes in substance use

Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging.

Number of participants who complete at least one dose of psilocybin

+1 more

Other study objectives

Changes in addiction-related constructs

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Diarrhea

Influenza

Headache

Sinus headache

Depressed mood

Depression

Insomnia

Suicidal Ideation

Lower resp. tract congestion

Oropharyngeal pain

Alcohol withdrawal syndrome

Migraine

Thrombocytosis

Constipation

Vomiting

Oedema

Peripheral swelling

Pyrexia

Dermatitis contact

Bronchitis bacterial

Eye infection

Fungal infection

Traumatic lung injury

Hyponatremia

Arthralgia

Musculoskeletal pain

Pain in extremity

Malignant melanoma

Dizziness

Hypoesthesia

Sedation

Anger

Anxiety

Restlessness

Cough

Rhinorrhea

Sinus congestion

Sexual abuse

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral PsilocybinExperimental Treatment1 Intervention

Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~750

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Methamphetamine Addiction include pharmacological agents like Bupropion and investigational treatments such as Psilocybin. Bupropion, an atypical antidepressant, works by inhibiting the reuptake of dopamine and norepinephrine, which helps reduce cravings and the subjective effects of methamphetamine. Psilocybin, a serotonin receptor agonist, is being studied for its potential to reset neural circuits and reduce addictive behaviors by modulating serotonin pathways. These treatments are crucial for Methamphetamine Addiction patients as they target the neurochemical imbalances and behavioral patterns associated with addiction, offering hope for more effective management and recovery.

Bupropion reduces methamphetamine-induced subjective effects and cue-induced craving.Time-course of methamphetamine-induced neurotoxicity in rat caudate-putamen after single-dose treatment.