Will Psychedelics Be the Next Big Push in Psychiatry Treatments?

What’s happening – Although federally regulated as Schedule 1 drugs, psychedelics are gaining recognition as potential psychiatric disorder treatments by the minute – especially after last week’s voting on state ballot measures. Oregon (via Measure 110) became the first state to decriminalize the possession and personal use of a number of scheduled drugs, including LSD, heroin, methamphetamine, psilocybin (the active compound found in magic mushrooms), and 3,4-MDMA (aka: ecstasy or molly) – pushing fast-forward on both their therapeutic research and use. Washington, DC (via Initiative 81) also decriminalized psilocybin and other psychedelics. Of note, Denver decriminalized psychedelic mushrooms in 2019 and a few other cities have decriminalized plant and fungi psychedelics in some fashion, including Oakland, Santa Cruz, and Ann Arbor.

Researchers at the Johns Hopkins Center for Psychedelic and Consciousness Research, UC San Francisco, and elsewhere have been exploring the benefits of psychedelics for a range of psychiatric disorders for several years. In particular, psilocybin has shown real promise to treat major depressive disorder (MDD) in individuals who are refractory to traditional medications. In addition, MDMA has demonstrated the potential to address PTSD.

But not everyone is on board yet. Despite a growing body of evidence showing the efficacy of psychedelics to treat certain conditions, those against the idea point to study limitations, including their tightly controlled medical settings and the risks of abuse with these substances.

The details – See Oregon’s approved Measure 110 and DC’s approved Initiative 81

Why it’s complicated – It’s unclear whether psychiatrists and therapists at large ready to put psychedelic-assisted therapy (a combination of closely monitored substance use and psychotherapy) into practice. The risks and contraindications of MDMA and psilocybin are still being investigated. And, the expected establishment of psilocybin service centers and clinics has not been worked out yet. Will they, for example, take their cues from ketamine provider models, or from cannabis and marijuana dispensaries? (Of note, 5 states legalized various uses of marijuana on Election Day 2020: Arizona, Mississippi, Montana, New Jersey, and South Dakota.)

The perspectives –

  • Rolling Stone was one of the first to share the #Election2020 win for psychedelics.
  • A Washington Post article points out that psychedelics are much harder for Blacks and other minority groups to access because of the stigma surrounding these drugs.
  • A Guardian piece, authored by the head of the Centre for Psychedelic Research at Imperial College London, takes a deeper dive into how psychedelic therapy (in conjunction with key psychology-supported sessions) accelerates the brain’s likelihood to change.
  • Medical News Today reported on a study that meditation and psilocybin together may increase the effectiveness of the psychedelic substance.

The conversation –

  • @tomangel pointed to Marijuana Moment tweeting “Oregon voters just passed a first-of-its-kind ballot measure to legalize psilocybin therapy. Its approval comes after several cities across the country passed local psychedelics decriminalization policies…”
  • @psyinvest reviews what decriminalization of psychedelics in Oregon and DC may mean for the stock market
  • A user touted a pending study out of UCL aiming to explore “the link between personality traits and meditation preferences…”

In practice –  UCSF psychedelic therapy researcher and Psycom Pro Editorial Advisor Andrew Penn, NP, reviews the latest research and hopes for psychedelic-assisted therapy in treatment-resistant patients. Update March 2021: See also, a new training program on how to deliver psilocybin therapy from COMPASS Pathways.

 

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Drug Update: New Schizophrenia, Bipolar Med May Reduce Unfavorable Weight Gain but Poses Risk with Opioid Takers

What’s happening – Weight gain has long been a serious concern for people taking antipsychotics for schizophrenia and bipolar 1 disorder. A study published in The Journal of Psychiatry, however, has revealed that ALKS 3831, an atypical antipsychotic manufactured by Alkermes that consists of both olanzapine and samidorphan reduced the amount of weight that users gained compared with just taking olanzapine. An FDA advisory panel recently gave the investigational drug – indicated for the treatment of adults with schizophrenia or with bipolar I disorder – a favorable endorsement.

While the medication may offer an appealing option for many patients, there is an important caveat: ALKS 3831 carries the risk of causing withdrawal in people who take opioids. To counteract the problem, Alkermes agreed to include a warning on the drug’s label, as well as to educate prescribing clinicians about the danger of withdrawal symptoms in patients taking this medication who have not disclosed their opioid usage.

The details –  Read the full study. (Correll, et al. Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study. J Psychiatry. ePub August 14, 2020.)

Why it’s complicated ­– There appear to be mixed reviews of the drug’s weight gain data as well as concerns regarding ALKS 3831 potential contraindication with opioids.

The perspectives –

  • A commentary raised concerns about the findings on ALKS3831, noting that the lipid and glycemic profiles did not show a corresponding improvement.
  • Evaluate Vantage speculated that while the FDA panel’s decision will culminate in approval of ALKS 3831, commercial sales of this medication may be slow for several reasons, including the risk of taking it with opioids and the fact that while weight gain is reduced, it is not eliminated with this medication.
  • BioWorld pointed out that while the panel did vote to recommend that the medication be approved, not everyone was in favor of this move. Of serious concern to dissenters was the fact that opioid use and psychiatric diagnoses often co-exist. Therefore the dangers posed by the drug may outweigh the benefits.

The conversation –

  • @HelioPsych said that exit responses from study participants revealed overall satisfaction with ALKS 3831 treatment.
  • @CNSSummit shared an interview with Alkermes’ Adam Simmons, director of clinical program management, on “ALKS 3831, which could one day become that frontline treatment for schizophrenia patients.”
  • @pharmaphorum tweeted: “@Alkermes has the phase 3 data it needs for #schizophrenia drug ALKS 3831 — but will it convince doctors?”

In practice – A clinical primer on when to prescribe first and second-generation antipsychotics and a look at when schizophrenia overlaps with other psychiatric comorbidities such as PTSD. Plus, a review of weight gain, antipsychotic use, and schizophrenia. And how to safely prescribe opioids with benzodiazepines.

COVID-19 Relief Funds Continue to Pay Out for Mental Health Providers

What’s happening – Mental health providers have shouldered a heavy financial burden since the onset of the pandemic – not only have they had to invest in new technologies to provide remote services but they have also lost revenue from reduced in-person visits, patients taking a pause from therapy, and so forth. The Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Paycheck Protection Program and Health Care Enhancement Act offered some relief but the application process was overly complicated.

The latest and third round of HHS relief ($20 billion) widened the pool. For starters, behavioral health providers that do not accept insurance were able to apply as were those who just started practicing in the year 2020.

The details – Visit the relief fund portal.

Worth noting – The deadline to apply for the latest round of funding was November 6. Payment amounts for new applicants who did not receive funding under earlier aid packages will be equal to 2% of patient care revenue. Those providers who already received funding under earlier distributions will get an add-on payment (the exact amount is still being worked out).

The perspectives –

  • StatNews.com talked about problems with previous provider relief fund distributions that pose “traps for unwary participants.”
  • Foley & Lardner LLP pointed to HHS’ guidelines on how recipients should report provider relief fund distributions, which seemed to cause more confusion for providers.
  • Plante Moran took a stab at explaining how to interpret new amendments from HHS that allow providers to apply funds against the total amount of patient revenue lost.

The conversation –

  • @Law_BMD linked to a list of questions providers should ask themselves when determining whether to apply for this latest round of COVID-19 aid.
  • @cjbiederman shared an article from the Commonwealth Fund’s To the Point blog that explores “ways in which community-based providers that serve #Medicaid and uninsured patients have been disadvantaged by HHS’s Provider Relief Fund distribution model, as well as actions. . .”
  • @TherapyMgmt tweeted: “There will no longer be a limit on providers’ use of Provider Relief Funds for covering lost revenue due to the #coronavirus…”

In practice – See our special report on how COVID-19 is changing the landscape for behavioral healthcare providers and how to effectively use teletherapy.

 

Last Updated: Jun 16, 2021