{"id":5324,"date":"2022-03-24T07:00:00","date_gmt":"2022-03-24T07:00:00","guid":{"rendered":"http:\/\/CBMiMmh0dHBzOi8vZmlsdGVybWFnLm9yZy9jb25uZWN0aWN1dC1tZG1hLXBzaWxvY3liaW4v0gEA"},"modified":"2022-03-24T07:00:00","modified_gmt":"2022-03-24T07:00:00","slug":"connecticut-could-open-east-coasts-first-psychedelic-medicine-centers-filter","status":"publish","type":"post","link":"https:\/\/thcinct.com\/?p=5324","title":{"rendered":"Connecticut Could Open East Coast&#8217;s First Psychedelic Medicine Centers &#8211; Filter"},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/thcinct.com\/wp-content\/uploads\/2022\/04\/connecticut-could-open-east-coasts-first-psychedelic-medicine-centers-filter.jpg\" class=\"ff-og-image-inserted\"><\/div>\n<p><span class=\"wpsdc-drop-cap\">C<\/span>onnecticut lawmakers have proposed a bill that would create the first psychedelic medicine centers on the East Coast. The bill anticipates that the Food and Drug Administration (FDA) will soon approve psilocybin and MDMA as legal treatment for depression and PTSD, respectively. If it passes, Connecticut will become an early mover as several states look to legalize psychedelics.<\/p>\n<p class=\"p1\"><span class=\"s1\">The bill, titled <a href=\"https:\/\/www.cga.ct.gov\/asp\/CGABillStatus\/cgabillstatus.asp?selBillType=Bill&amp;bill_num=HB5396\"><span class=\"s2\">HB 5396,<\/span><\/a> would aim to provide MDMA and psilocybin for medical use.&nbsp;It would serve only \u201cqualified patients\u201d\u2014including veterans, retired first responders, \u201cdirect care\u201d healthcare workers and people from a \u201chistorically underserved community\u201d with a serious or life-threatening mental illness. Medical providers will need permission from the FDA to offer the drugs through \u201cexpanded access\u201d\u2014a rule that allows medications to be administered&nbsp;before they\u2019re officially approved in special cases.<\/span><\/p>\n<blockquote>\n<p>\u201cSitting back and not doing something is costing lives.\u201d<\/p>\n<\/blockquote>\n<p><span class=\"s1\">The bill <a href=\"https:\/\/www.marijuanamoment.net\/connecticut-lawmakers-approve-bill-to-fund-psilocybin-and-mdma-therapy\/\"><span class=\"s2\">was approved<\/span><\/a> by the state legislature\u2019s Public Health Committee on March 18, with bipartisan support. To become law, it must pass a full floor vote and be signed by Governor Ned Lamont.&nbsp;<\/span><\/p>\n<p>\u201cI think that by sitting back and not doing something, as we heard the other day, is costing lives day after day after day,\u201d said Representative Michelle Cook (D), a co-sponsor of the bill, during a public hearing. \u201cDoing nothing, I think, would be criminal in this regard.\u201d<\/p>\n<p class=\"p1\"><span class=\"s1\">The state\u2019s health department would create a pilot program to give out grants. These would pay for patients to receive psychedelic treatment, and help cover providers\u2019 costs. Onyx Scientific, a UK-based company that manufactures medical-grade psilocybin and MDMA for clinical trials, would be the likely source of drugs for this program. The pilot would run until psilocybin and MDMA were fully approved by the FDA. The grant fund would be funded partially by the state, and could also receive donations.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">If the bill becomes law, the state must begin soliciting applications from potential providers by October 31, and approve at least three by December 28. Each treatment site would initially be granted $500,000. The state would also set up an advisory board, with several members appointed by different elected and state officials, to focus on further psychedelic reforms.<\/span><\/p>\n<p class=\"p1\">Both MDMA (also known as \u201cecstasy\u201d or \u201cmolly\u201d) and psilocybin (\u201cmagic mushrooms\u201d) are drugs classified under Schedule I, the most restricted category in federal law. They share this status with marijuana, heroin and LSD. Defined as \u201cdrugs with no currently accepted medical use and a high potential for abuse,\u201d even research on them is highly restricted. If approved by the FDA as a medicine, the drugs would need to be rescheduled\u2014at least to Schedule II\u2014or legalized entirely.<\/p>\n<p class=\"p1\"><span class=\"s2\">The FDA <a href=\"https:\/\/www.scientificamerican.com\/article\/a-strategy-for-rescheduling-psilocybin\/\">isn\u2019t the only agency<\/a> with authority here.<\/span><span class=\"s1\"> It\u2019s the Drug Enforcement Administration (DEA), <a href=\"https:\/\/filtermag.org\/dea-psychedelics-schedule\/\"><span class=\"s2\">notoriously resistant to reform<\/span><\/a>, which normally decides how drugs are scheduled. President Biden can, through executive order, require the attorney general, who has authority over the DEA, to reschedule certain drugs. Congress can also change drug laws through legislation\u2014though it has so far <a href=\"https:\/\/filtermag.org\/more-act-vote-marijuana-decriminalization\/\"><span class=\"s2\">failed to do so<\/span><\/a><span class=\"s2\"> in the case of marijuana<\/span>. Lastly, the Supreme Court can order drugs to be rescheduled if a lawsuit is brought against the DEA\u2014<span class=\"s2\">but this approach <\/span><a href=\"https:\/\/www.marijuanamoment.net\/supreme-court-declines-to-hear-marijuana-case-challenging-deas-restrictive-classification\/\"><span class=\"s2\">has also failed<\/span><\/a><span class=\"s2\"> with marijuana.<\/span><\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">States can also just choose to ignore federal law and make their own changes\u2014as 18 states and Washington, DC have done to legalize marijuana, and <a href=\"https:\/\/filtermag.org\/oregon-psilocybin-business-conflicts\/\"><span class=\"s2\">now Oregon has done<\/span><\/a> to legalize psilocybin for therapeutic use. The proposed bill in Connecticut doesn\u2019t take that approach, and would instead see the state more closely follow the federal government\u2019s lead.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">In the field of psychedelic science, the Multidisciplinary Association for Psychedelic Studies (MAPS) is the closest to <a href=\"https:\/\/www.nature.com\/articles\/s41591-021-01336-3\"><span class=\"s2\">completing the research necessary<\/span><\/a> for MDMA to become FDA-approved for severe PTSD. <\/span><span class=\"s1\">Meanwhile, COMPASS Pathways is researching psilocybin for treatment-resistant depression, and <a href=\"https:\/\/ir.compasspathways.com\/news-releases\/news-release-details\/compass-pathways-announces-positive-topline-results\"><span class=\"s2\">will soon begin<\/span><\/a> the final phase of clinical trials. Another organization, Usona Institute, is researching psilocybin for major depressive disorder, <span class=\"s2\">and <\/span><a href=\"https:\/\/usonaclinicaltrials.org\/major-depressive-disorder-psilocybin-clinical-trial-psil201\"><span class=\"s2\">is currently<\/span><\/a> in Phase 2 trials.<\/span><\/p>\n<blockquote>\n<p><span class=\"s1\">The \u201cexpanded access\u201d rule is a realistic pathway for only a tiny fraction of the millions of people who may want these treatments.<\/span><\/p>\n<\/blockquote>\n<p class=\"p1\"><span class=\"s1\">Before these drugs are fully approved, it is possible for patients to get them through \u201cexpanded access.\u201d <span class=\"s2\">This is an <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/public-health-focus\/expanded-access#:~:text=Sometimes%20called%20%E2%80%9Ccompassionate%20use%E2%80%9D,,clinical%20trials%20when%20no%20comparable\"><span class=\"s2\">FDA rule<\/span><\/a> that allows patients with a life-threatening illness to receive an un-approved experimental medicine \u201cwhen no comparable or satisfactory alternative therapy options are available.\u201d MAPS was actually approved to offer MDMA for PTSD through expanded access <a href=\"https:\/\/www.clinicaltrialsarena.com\/news\/maps-expanded-access-ptsd-therapy-mdma\/\"><span class=\"s2\">in December 2019<\/span><\/a>\u2014but only to a very small group of 50 patients. <\/span><span class=\"s1\">Both <a href=\"https:\/\/compasspathways.com\/our-research\/psilocybin-therapy\/clinical-trials\/compassionate-use-policy\/\"><span class=\"s2\">COMPASS<\/span><\/a> and <a href=\"https:\/\/www.usonainstitute.org\/expandedaccess\/\"><span class=\"s2\">Usona<\/span><\/a> accept applications from patients who want to get psilocybin through expanded access, but can\u2019t guarantee they will be approved. <\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Expanded access is inherently very restrictive, and a realistic pathway for only a tiny fraction of the millions of people who may want these treatments. <\/span><span class=\"s1\">It is also not covered by health insurance, which explains why Connecticut lawmakers are proposing state grants to pay for it. Treatment costs for MDMA for PTSD <a href=\"https:\/\/filtermag.org\/mdma-therapy-people-color\/\"><span class=\"s2\">are estimated<\/span><\/a> to reach between $12,000-20,000 per patient (while the drugs themselves are cheap, psychedelic therapy guidelines may call for many hours of psychotherapists\u2019 time).&nbsp;<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">But the Connecticut bill doesn\u2019t pretend to be a way to get psychedelic healing to the masses. Instead, <a href=\"https:\/\/filtermag.org\/canada-psilocybin-mental-health\/\"><span class=\"s2\">it\u2019s similar to what the Canadian government is doing<\/span><\/a>\u2014granting permission to a very small group of people with severe illnesses&nbsp;in the name of compassion. It\u2019s a small step in the right direction that could help pave the way to wider access.<\/span><\/p>\n<hr>\n<p><em>Photograph of a psilocybin therapy experiment at Johns Hopkins University by&nbsp;Matthew W. Johnson via <a href=\"https:\/\/commons.wikimedia.org\/wiki\/File:Johns_Hopkins_psilocybin_session_room-SessionRm_2176x.jpg\">WikiMedia Commons<\/a>\/<a href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/3.0\/deed.en\">Creative Commons 3.0<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Connecticut lawmakers have proposed a bill that would create the first psychedelic medicine centers on the East Coast. The bill anticipates that the Food and Drug Administration (FDA) will soon approve psilocybin and MDMA as legal treatment for depression and PTSD, respectively. If it passes, Connecticut will become an early mover as several states look to legalize psychedelics. The bill, titled HB 5396, would aim to provide MDMA and psilocybin for medical use.&nbsp;It would serve only \u201cqualified patients\u201d\u2014including veterans, retired first responders, \u201cdirect care\u201d healthcare workers and people from a \u201chistorically underserved community\u201d with a serious or life-threatening mental illness&#8230;. <\/p>\n","protected":false},"author":1,"featured_media":5325,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[2],"tags":[],"class_list":["post-5324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-featured"],"jetpack_featured_media_url":"https:\/\/thcinct.com\/wp-content\/uploads\/2022\/04\/connecticut-could-open-east-coasts-first-psychedelic-medicine-centers-filter.jpg","_links":{"self":[{"href":"https:\/\/thcinct.com\/index.php?rest_route=\/wp\/v2\/posts\/5324","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thcinct.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thcinct.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thcinct.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thcinct.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5324"}],"version-history":[{"count":0,"href":"https:\/\/thcinct.com\/index.php?rest_route=\/wp\/v2\/posts\/5324\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/thcinct.com\/index.php?rest_route=\/wp\/v2\/media\/5325"}],"wp:attachment":[{"href":"https:\/\/thcinct.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5324"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thcinct.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5324"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thcinct.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}