Psilocybin for Methamphetamine Addiction

Overseen By John A Vanchiere, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Kevin Murnane

Must not be taking: SSRIs, SNRIs, MAOIs, Lithium

Disqualifiers: Cardiovascular disease, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether psilocybin, a substance found in certain mushrooms, can help individuals stop using methamphetamine. Researchers aim to determine if it reduces cravings and improves mood, thinking, and overall quality of life. They seek participants who have used meth in the last month, wish to quit, have been in a treatment facility for at least a week, and have not used psychedelics in the last three years. Participants will attend a combination of in-person and online sessions to prepare for and follow up on the treatment experience. As an Early Phase 1 trial, this research focuses on understanding how psilocybin works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. If you're on medications that affect serotonin or specific enzymes, you should stop them at least 5 half-lives before starting psilocybin.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research has shown that psilocybin is generally safe and has been studied for treating various conditions. In past studies, psilocybin-assisted therapy for alcohol dependence proved safe and effective, indicating a good safety record when used correctly.

Early trials also show that psilocybin, when combined with therapy, is safe and manageable for participants. Although specific data for methamphetamine use disorder remains limited, findings from other uses offer some reassurance.

Since this trial is in its early stages, it primarily aims to determine if the treatment is safe and well-tolerated. Psilocybin has been tested in different settings, supporting its potential for safe use, but this trial will help confirm its safety specifically for methamphetamine addiction. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for methamphetamine addiction, which often include behavioral therapy and medications like bupropion or naltrexone, psilocybin offers a novel approach. Psilocybin is a psychedelic compound that works by targeting serotonin receptors in the brain, potentially leading to profound changes in perception, mood, and cognition. Researchers are excited about psilocybin because it might help break the cycle of addiction by promoting new ways of thinking and behavior, possibly with just a single or few doses. This could offer a faster, more profound shift compared to the gradual effects of current therapies.

What evidence suggests that psilocybin might be an effective treatment for methamphetamine addiction?

Research has shown that psilocybin, when used in therapy, yields promising results for treating substance use problems. In this trial, participants will receive psilocybin to evaluate its effectiveness in managing methamphetamine dependence, particularly after withdrawal. Users of psilocybin have reported emotional improvement, better social interactions, and reduced substance use. Early findings from similar studies suggest positive outcomes, offering hope that psilocybin could assist those struggling with methamphetamine addiction. ^{2 3 4 5 6}

Who Is on the Research Team?

Kevin S Murnane, PhD

Principal Investigator

Louisiana State University Health Science Center Shreveport

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 25-65 in Northern Louisiana who want to stop using methamphetamine, identify it as their drug of choice, and have used it within the last month. Participants must not have used psychedelics recently (or at all), be at a local treatment facility for over a week, and commit to several telehealth and in-person sessions.

Inclusion Criteria

I scored 3 or more for my dependency level.

I have been at the specified treatment center for at least a week.

I have used methamphetamine in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preparatory Sessions

Three preparatory sessions to establish trust and prepare participants for the psilocybin session

2 weeks

2 visits (virtual), 1 visit (in-person)

Psilocybin Administration

Participants receive a single 25 mg dose of psilocybin with monitoring of cardiovascular measures and subjective experiences

1 day

1 visit (in-person)

Post-session Integration

Two telehealth sessions to discuss insights and challenges from the psilocybin experience

1 week

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 30, 60, and 120 days post-psilocybin

4 months

2 visits (virtual), 1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests if psilocybin (25 mg) can help people quit methamphetamine by improving abstinence rates, reducing cravings, enhancing mood, cognitive function, and life quality. It includes preparatory sessions with researchers before taking psilocybin and follow-up meetings afterwards.

How Is the Trial Designed?

Group I: Psilocybin Experimental Treatment 1 Intervention

Participants will be administered 25mg of Psilocybin.

Who Is Running the Clinical Trial?

Kevin Murnane

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10043240/

Exploring psilocybin-assisted psychotherapy in the treatment ... Early phase clinical trials of psilocybin-assisted psychotherapy have demonstrated promising results for treatment of other substance use ...

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1490907/full

Psilocybin-assisted psychotherapy for methamphetamine ... This study suggests that PAT (following inpatient MA withdrawal management) may offer a scalable, safe, and effective approach for treating MA dependence.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625001528

Exploring psychedelic experiences among people who ... Psychedelic use among people who use methamphetamine may improve mood and social function, and reduce substance use.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06899594?term=psilocybin&viewType=Table&rank=6

NCT06899594 | Psilocybin for Methamphetamine Addiction The primary purpose of this study is to preliminarily determine if the use of psilocybin to promote abstinence from methamphetamine is feasible and well ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70187?af=R

Psilocybin‐assisted psychotherapy for methamphetamine ... Prior studies of PAT for substance use disorders have found similarly positive efficacy signals [51]. A single-arm pilot study of PAT to treat ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05322954

NCT05322954 | Study of the Safety and Feasibility of ... The objective of this study is to determine the safety of psilocybin in adult participants with MUD. Eligible participants will be adults with methamphetamine ...