Brain Wellness “Spas”—Anticipating the Off-label Promotion of Psychedelics

Wexler, Anna; Sisti, Dominic A.

doi:10.1001/jamapsychiatry.2022.1619

Cited by 15 publications

(11 citation statements)

References 9 publications

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“…This last point is critical as a significant safety concern associated with drugs like psilocybin, MDMA, or LSD is the suggestibility and vulnerability of the patient while under the influence of the drug . Thus, training and clinical oversight is necessary to ensure safety and also therapeutic efficacy for this divergent class of treatments . Some efforts along these lines are underway in the US and Canada …”

Section: Discussionmentioning

confidence: 99%

Psychedelic Drug Legislative Reform and Legalization in the US

et al. 2023

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ImportancePsychedelic drugs are becoming accessible in the US through a patchwork of state legislative reforms. This shift necessitates consensus on treatment models, education and guidance for health care professionals, and planning for implementation and regulation.ObjectiveTo assess trends in psychedelics legislative reform and legalization in the US to provide guidance to health care professionals, policy makers, and the public.Evidence ReviewData were compiled from legislative databases (BillTrack50, LexisNexis, and Ballotpedia) from January 1, 2019, to September 28, 2022. Legislation was identified by searching for terms related to psychedelics (eg, psilocybin, MDMA, peyote, mescaline, ibogaine, LSD, ayahuasca, and DMT). Bills were coded by an attorney along 2 axes: which psychedelic drugs would be affected and in what ways (eg, decriminalization, funding for medical research, and right to try). To explore drivers and rates of legislative reform, data were compared with other state indices including 2020 presidential voting margins and marijuana legislative reform.FindingsTwenty-five states have considered 74 bills (69 legislative initiatives, 5 ballot measures); 10 bills were enacted, and 32 were still active. The number of psychedelic reform bills introduced during each calendar year increased steadily from 5 in 2019 to 6 in 2020, 27 in 2021, and 36 in 2022. Nearly all bills specified psilocybin (67 [90%]), and many also included MDMA (3,4-methylenedioxy-methamphetamine; 27 [36%]). While bills varied in their framework, most (43 [58%]) proposed decriminalization, of which few delineated medical oversight (10 of 43 [23%]) or training and/or licensure requirements (15 of 43 [35%]). In general, bills contained less regulatory guidance than the enacted Oregon Measure 109. While early legislative efforts occurred in liberal states, the margin between liberal and conservative states has decreased over time (although the difference was not significant), suggesting that psychedelic drug reform is becoming a bipartisan issue. In addition, an analytic model based on marijuana legalization projected that a majority of states will legalize psychedelics by 2034 to 2037.Conclusions and RelevanceLegislative reform for psychedelic drugs has been proceeding in a rapid, patchwork fashion in the US. Further consideration should be given to key health care issues such as establishing (1) standards for drugs procured outside the medical establishment, (2) licensure criteria for prescribers and therapists, (3) clinical and billing infrastructure, (4) potential contraindications, and (5) use in special populations like youths, older adults, and pregnant individuals.

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Section: Discussionmentioning

confidence: 99%

Psychedelic Drug Legislative Reform and Legalization in the US

et al. 2023

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“…In addition, researchers should explore new designs that reduce required resources and functional unblinding. Importantly, clinicians need to be aware of the rapid development of private clinics that are primed to provide off-label psychedelic treatment earlier than the evidence suggests 41 . Appropriate regulations need to be established to ensure that patients are protected from off-label use until there is more robust data on the safety, tolerability, and antidepressant efficacy of psychedelics.…”

Section: Discussionmentioning

confidence: 99%

“…Importantly, clinicians need to be aware of the rapid development of private clinics that are primed to provide off-label psychedelic treatment earlier than the evidence suggests. 41 Appropriate regulations need to be established to ensure that patients are protected from off-label use until there is more robust data on the safety, tolerability, and antidepressant efficacy of psychedelics. The prevention of premature off-label use is also critical in enhancing the success of further rigorous clinical trials addressing the current gaps in the evidence.…”

Section: Discussionmentioning

confidence: 99%

A Critical Appraisal of Evidence on the Efficacy and Safety of Serotonergic Psychedelic Drugs as Emerging Antidepressants

Ledwos

Rosenblat

Blumberger

et al. 2022

J Clin Psychopharmacol

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Purpose/BackgroundThere has been resurgence of interest in the therapeutic use of serotonergic (“classic”) psychedelics in major depressive disorder (MDD) and end-of-life distress. This commentary offers a critical appraisal of current evidence for antidepressant effects of classic psychedelics from contemporary clinical trials and highlights pitfalls that should be addressed before clinical translation.Methods/ProceduresA narrative review was conducted to identify clinical trials of serotonergic psychedelics for the treatment of MDD and end-of-life distress. Trials published between January 1990 and May 2022 were identified on PubMed using combinations of search terms.Findings/ResultsPsilocybin, lysergic acid diethylamide, and ayahuasca have clinical trials to evaluate antidepressant effects. Two studies showed preliminary positive effects of single-dose ayahuasca for treatment-resistant depression. Similar results were seen in lysergic acid diethylamide for end-of-life distress. Small randomized clinical trials (RCTs) of psilocybin combined with psychotherapy showed superiority to waitlist controls and comparable efficacy and safety to an active comparator in MDD, with additional RCTs showing efficacy in end-of-life distress. Adverse events associated with psychedelics were reported as mild and transient. Small homogenous samples, expectancy bias, functional unblinding, and lack of consensus and standardization of psychotherapy are major limitations of all studies.Implications/ConclusionsGiven the methodological limitations of published RCTs, the evidence supporting the efficacy and safety of serotonergic psychedelics for depression is currently of low level. Future research should assess the role of expectancy and psychedelic effects in moderating and mediating treatment response. Innovative trial designs are needed to overcome functional unblinding. For now, psychedelics should remain experimental interventions used within clinical trials.

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“…Whether concurrent declines in racially biased policing and incarceration ( 59 ) balance such harms may be “unanswerable” ( 60 ). The capitalized industry is patenting color schemes and soundtracks for private franchise PAT ( 61 ) serving the wellness “spa” market ( 62 ), while unregulated freelance “trip guides” or retreats of dubious accountability and safety ( 63 , 64 ) may prioritize profit over beneficence. Lightly regulated or PAT might help many and harm few, but this commercialization severs the source of transformational, sacramental cultural power.…”

Section: Clinical and Policy Prioritiesmentioning

confidence: 99%

Lifeboat ethics, risk, and therapeutic opportunity: an appeal for equitable psychedelic therapy access in the “high-risk” addiction patient

Black

2023

Front. Psychiatry

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Psychedelic-assisted treatment (PAT) for mental health is in renaissance. Psilocybin and MDMA stand near FDA approval, and US cities and states are decriminalizing or regulating the non-clinical use of psilocybin. However, neither FDA indications nor a regulated use model sufficiently address the complex needs and opportunities for an improved treatment of addiction. When paired with disability and social dispossession, addiction increasingly burdens informal care networks, public safety, and particularly healthcare systems. Stigma and mistreatment alienate people from opportunities for care and multiply the costs of providing care. This dynamic worsens socially determined resource limitations, enforcing stark ethical choices and perpetuating socioeconomic inequities, isolation, mental illness, medical illness, overdose, suicide, and violence. In order for psychedelic treatments to achieve their greatest utility to population health, we must intentionally develop regulatory, clinical, and payment systems supporting clinical research, rigorous safety monitoring, and implementation to address these immense needs and reduce the barriers to engagement for those who now bear the costs, including those who work at the front lines of addiction care. To achieve full fruition, I advocate for a collaborative approach, built from within networks of mutual social support but linked and accountable to public institutions charged with the equitable dissemination of these therapies for the greatest social and health equities. Rather than relegating PAT to the needs of the commercially insured or wellness markets, this is the moment to learn from ancient traditions of ritualized sacramental use, organized around faith in our mutual dependency and accountability, and to capture an opportunity to improve population health and equity. To miss this opportunity is to accept the status quo in the midst of a growing emergency, for lack of moral vision and intention to change our habits.

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Brain Wellness “Spas”—Anticipating the Off-label Promotion of Psychedelics

Cited by 15 publications

References 9 publications

Psychedelic Drug Legislative Reform and Legalization in the US

Psychedelic Drug Legislative Reform and Legalization in the US

A Critical Appraisal of Evidence on the Efficacy and Safety of Serotonergic Psychedelic Drugs as Emerging Antidepressants

Lifeboat ethics, risk, and therapeutic opportunity: an appeal for equitable psychedelic therapy access in the “high-risk” addiction patient

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