#MDMA approval
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#Medical device Registration in Saudi Arabia#SFDA#MDNR listing#MDMA approval#KSA#medical devices#medical device approval
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VALORANT HEADCANONS PT. II
Gonna start off with the agent ages:
Brimstone: Late forties to early fifties Viper: Late thirties to early forties Omen: Around the same ages as Brimstone and Viper Cypher: Late thirties Sova: Mid thirties Sage: Mid thirties Phoenix: Early twenties Jett: Early twenties Raze: Early to mid twenties Breach: Early to late forties Reyna: Late thirties to early forties Killjoy: Early to mid twenties Skye: Late twenties Yoru: Late twenties Astra: Early thirties Chamber: Early thirties Neon: Early twenties Fade: Mid thirties Harbor: Early to mid thirties Gekko: Early to mid twenties Deadlock: Mid thirties
Viper listens to Panic! At The Disco.
Breach plays drums while Sova plays guitar in their little jam group. Brimstone refuses to play bass for them.
All agents use WhatsApp for Protocol business. It's end-to-end encryption was given the Cypher stamp of approval.
Fade likes Radiohead (but not in a femcel way in a cool way)
Killjoy and Raze definitely pop some MDMA and other club drugs when raving. No doubt those two have been rolling around Europe.
Viper smokes up #420blazin
Speaking of smoking up, I think Gekko, Phoenix and Jett hit the zaza too. A lot more than Viper.
Since Riot games are canon, as KJ plays League, Jett plays Valorant.
If I think about Valorant in Valorant it becomes a dark and deep rabbit hole so that's the furthest I'm exploring the concept.
Gekko has nipple piercings >:3
Valorant HQ is somewhere in LA, mostly because that's where Riot HQ is.
The international agents, so everyone barring like three or so of them, live at HQ, while the American ones have places outside the HQ. I feel like Brim would live at HQ while Viper would live in her own apartment. At least, that's what I gathered from her takeover cinematic.
Gekko, cause he's a wanted, hides out at HQ.
Reyna owns her own place outside of HQ and switches between the two depending on how annoyed she is at some members of the Protocol. Same with Viper.
#valorant#valorant headcanons#valorant killjoy#valorant raze#valorant viper#valorant gekko#valorant brimstone#valorant jett#valorant reyna#valorant phoenix#valorant cypher#valorant breach
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Australia is in the news again
Farzam Mehrabi was found guilty of drugging and raping women. (ABC News: David Weber)
In short:
Perth dentist Farzam Mehrabi has been found guilty of drugging and raping several women he met on dating apps.
He was found guilty of stupefying and raping three women, raping two further women and stupefying another.
Mehrabi will be sentenced on December 17.
A jury has found a Perth dentist guilty of drugging and raping women he met through dating apps.
The WA District Court had heard that Farzam Mehrabi put drugs into his victims' drinks without their knowledge before sexually assaulting them.
Mehrabi's trial started in early August, with the dentist facing 22 charges, including sexual penetration without consent, stupefying in order to commit an indictable offence, and impeding someone's normal breathing.
The offences occurred in February and March in 2022.
He was found guilty of stupefying and raping three women, raping two further women and stupefying another.
Mehrabi was captured on CCTV in bars, putting drugs into the drinks of women he was dating.
One of those women, who had found him on Tinder, said she experienced blurred vision after drinking a martini, and remembered she "didn't really like the taste".
She was later raped at Mehrabi's home, where he choked her without her consent.
Perth man Farzam Mehrabi will be sentenced on December 17. (ABC News: David Weber)
Another victim told the court Mehrabi told her "he had the best MDMA" and she had some with him.
But she said that on another occasion she had been drinking with Mehrabi in his garden before she started seeing in "fours" and vomited.
She said she then blacked out and could not remember anything until she woke in his bedroom the next day, and later discovered injuries on her body.
She went to police and they recorded a phone call with Mehrabi, who claimed they had got drunk before having consensual sex outside.
Media report caused victim to come forward
Another victim came forward after seeing some media coverage saying "Perth dentist accused of spiking drinks".
The urine sample of a woman who was not assaulted, but who had her drink spiked, showed MDMA, methylone and methylamphetamine.
The court had been told that in some cases, the women had engaged in consensual drug use and sex with Mehrabi, who often talked about drug use, particularly MDMA.
Farzam Mehrabi was found guilty of 21 of 22 charges in the District Court of WA on Wednesday. (ABC News: David Weber)
His defence was that none of the sex was without consent, and he liked to be dominant with his partners.
The victims were aged in their late teens and early 20s, and the 34-year-old denied he was trying to deceive anyone by lowering his age on dating apps and targeting younger women.
Mehrabi was found guilty of 21 of the 22 charges the jury was considering, and found not guilty of one of the stupefying charges.
He had already pleaded guilty to two charges of supplying a prohibited drug and one charge of offering to sell or supply a prohibited drug.
Two of the women had not been assaulted, but told the court they had been drugged by Mehrabi.
A CCTV image of Farzam Mehrabi spiking a woman's drink. (Supplied)
Mehrabi was remanded in custody and will be sentenced on December 17.
Judge Troy Sweeney approved the release of footage showing Mehrabi spiking drinks to the media because she said there was an educational aspect for the public.
#Australia#Perth#Farzam Mehrabi is a rapist#Spiking drinking#Dangerous men using g dating g apps#Men choking women#Cops not listening to women#A dentist often talked about drug use#Men lying anout their age on dating apps
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I'm gonna distribute drugs 2 hours before the concert starts so me and all my guests can be high when the music plays at Madison Square Garden.
Camila Cabello is gonna play a full set before Lorde is gonna play half a set before Taylor Swift is gonna play a full Taylor Swift set and then, we're gonna play a full Automaton Dreams set and then, a full Drugs, Sex, And Money set at Madison Square Garden — Taylor Swift is opening for my solo band, is opening for my all star band.
Taylor, I need you to invite your blonde Swiftie fans to be in the crowd with us.
Lorde can open for Taylor Swift.
Invite all your best friends and celebrities — the kind of people you trust not to betray us.
Doors will probably open at noon and we'll run the festival until 3 am.
We'll film the entire festival and release it as a 12 hour movie.
I'll dose everyone who comes to the crowd with drugs — anyone who wants some.
Where are we throwing the afterparty so we can go home and finishing tripping?
#NYPD #NYCMayorEricAdams
#Police #DEA #DEAHQ #UNODC #GhadaFathiWaly
I'm gonna bring MDMA, LSD, LSA, Ayahuasca, Psilocybin, Mescaline, THC, Oxycodones, Adderall, Cocaine, Salvia, DMT, Ibogaine, 2CI, Methamphetamine, 2CB, Bufotenine, Vyvanse, and PCP.
Everyone call all of your drug dealers and tell them to start manufacturing the drugs for me so I can buy them for the movie because I don't grow half that shit.
Everyone who is dealing drugs to me has clemency on all charges, despite all circumstances.
I'm gonna be on LSD and methamphetamine and Adderall and Vyvanse so I can stay up for the whole length of the concert. I'm gonna take microdoses of the rest of the drugs because I need to perform.
I just realized we could have a week long festival at Madison Square Garden so we can have more performers and more time to hang out and do drugs.
Who wants to perform? I'll pay you to perform — I'll pay y'all very well — how much would you charge me to perform?
I want #BillieEilish #KatyPerry #AutomatonDreams #TaylorSwift #BakerGrace #HeatherLaRose #DrugsSexAndMoney #Lorde #CamillaCabello #TheWeeknd #BonJovi #CharliXCX #EmpireOfTheSun #CultRecords #KingsOfLeon #ArcticMonkeys #TameImpala #DevendraBanhart #MGMT #LilWayne #EdSheeran #JustinBieber #TheKidLaroi #LanaDelRey #TheStrokes #TheVoidz #AlbertHammondJr #SummerMoonBand #MileyCyrus #HarryStyles #Grimes #AlexandraSavior #BeachHouse #JackHarlow to perform.
I want y'all to perform your singles, not your new songs — only your coolest hits.
I'm gonna buy out the venue so we can have an invite only crowd.
Don't forget to wear ear plugs.
We're gonna be serving raw vegan cold pressed juice and raw vegan food at the festival.
Call Madison Square Garden and tell them I'm offering fifteen billion dollars to buy out the venue for a week and I want legal nudity and sex allowed inside the venue so we can have sex inside the venue.
I'll be distributing drugs during the filming of my movie — it's not just a movie, I'm actually going to be distributing drugs in real life — it's not a fiction.
I'm asking for permission to please be allowed to manufacture and distribute drugs for my movie and I want The DEA and The UNODC and The CND to send uniformed and undercover police agents with me so y'all can approve of it.
We can't put the poison in the drugs, it has to be pure because we're trying to be healthy.
I'll pay you anything you ask for and you can date my daughters and my wives.
#Police #NYPD #Government #DEA #DEAHQ #UNODC #CommissionOnNarcoticDrugs #GhadaFathiWaly
Don't invite a lot of dudes to The Madison Square Garden Festival, preferably chicks.
#Dallas #DallasTX #DallasTexas #DTX #FBI #UnitedNationsHumanRights #police #JoeBiden #DallasPoliceDepartment #TheWhiteHouse #DOJ #DepartmentOfJustice #CIA #CentralIntelligenceAgency #TheSupremeCourt #SCOTUS #HumanRightsWatch #UNPGA #POTUS #HouseGOP #HouseRepublicans #congress #senate #SenateDemocrats #SenateGOP #EuropeanUnion #EUCouncil #EuropeanParliament #parliament #EuropeanUnionComission #EUComission #TheFederalReserve #InternationalCriminalCourt #UNPeacekeeping #UnitedNationsPeacekeeping #UnitedNations #UN #USArmy #NATO #president #primeminister #10DowningSt #governor #mayor #citycouncil #intelligence #military #Europe #America #NewYork #NewYorkCity #American #elitesociety #RoyalFamily #news #FoxNews #US #UnitedStates #ODNI #ODNIgov #DirectorOfNationalIntelligence #sheriff #sheriffs #LAPD #LosAngeles #California #LosAngelesPoliceDepartment #NYPD #WorldBank #UNPOL #InternationalMonetaryFund #IMF #capitalism #NSA #WEF #WorldEconomicForum #LieutenantGovernorDanPatrick #DanPatrick #GovernorGregAbbott #GregAbottt #CsabaKorosi #GeorgeWBush #TonyBlair #NationaSecurityAgency #NSAgov #NSAcyber #UNWomen #MichelleBachelet #RobertaMetsola #LizTruss #HillaryClinton #UrsulaVonderleyen #MarjorieTaylorGreene #CsabaKorosi #VladimirPutin #Kremlin #DonaldTrump #DonaldTusk #BorisJohnson #JillBiden #women #girls #Wikileaks #Amnesty @amnestyusa @amnestyinternationalub-blog #AmnestyInternational #Pontifex #SkullAndBonesSociety #Illuminati #Rosicrucians #Freemasons #DEA #DEAHQ #CND #UNODC #GhadaFathiWaly #BIS #BankForInternationalSettlements
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MDMA inched closer to approval in the US for PTSD, thanks to positive results from a large multi-site, double-blind, randomized trial—the gold standard for testing drug safety and efficacy and psilocybin gained steam as a treatment for severe depression.
Read More: https://thefreethoughtproject.com/solutions/psychedelic-drugs-are-rushing-towards-approval-for-therapy-heres-whats-next
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yes
ok buckle up. some of it is going to come up in the fic a friend of mine and i r writing so 🤷♂️
Benjamin Dunn isn’t his real name. He IS called Benjamin, but he has two other last names. He shortened one to make it so it’s Dunn, when he got into the IMF
He was born into an extremely wealthy and quite conservative family back in London, but his parents never took much care into what he did
He’s never gotten love and support from his parents, despite going into Oxford and the like, which makes it that he’s always craving reassurance and validation from people
He was still figuring his sexuality out in uni (knew he was gay, knew his parents wouldn’t approve of it) so he got a girlfriend and presented her to his parents, and was briefly fiancé
Mixed with the wrong crowds a bit in Oxford but it was just smoking pot and the occasional line of coke
Mixed with cool crowds (punks and the like) and he dyed his hair black and got piercings
His drug addiction got worse when he got his first job at 23, into a data analysis firm, because then the stress of it all despite his young age led him to fall into hard drugs (meth, coke, mdma and heroin) and he couldn’t get out of it
Has a pronounced RP accent he changed to a London one when he moved to the IMF to sound less ‘odd’
Joined the IMF after a traumatic event that would’ve sent him to jail for years had he not fled the scene and overdosed immediately after
As soon as he joined the IMF he changed most of his personality to fit the sweet and unassuming technician
Mind you he was always a geek and a nerd, but he made it even more obvious when he got there. He can secretly be very bitter and vehement about things that annoy him
Has a horribly short temper and he tries to work on that constantly
Is the type of genius that can be good at anything if he WORKS for it. he might not grasp it at first, but he’s an extremely hard worker and it pays off
Joined the field agent program because he wanted to be closer to Ethan and because he was extremely bored behind his desk
Traded his graphic tees and the likes to switch back to bespoke suits like he used to wear when he was a kid and he feels constantly trapped by the past
Never told anyone about why he joined the IMF (he’s deeply ashamed of it)
Has a actually a surprisingly good marksmanship even if he doesn’t particularly like shooting people, if he ever were to lose his mind completely he’d beat people up to the pulp in hand in hand combat
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We went to Cecilia's funeral this week in a marathon late-night train ride, 8am subway to cathedral where queers with their tits out got to shout Puta!! Whore! Santa Cecilia in front of flustered priests, midday repass/dance party at nowadays, zoom class on primarily the ICJ back in ridgewood and then the the 10pm chinatown bus home. A and I travel well together but also have a tendency to punk it if the alternative isn't cheap or convenient enough. I ran into the hot girl I fucked in a tent this summer and her new girlfriend as they were leaving the repass to go get the mdma they had left at home. She said can we make out or is that not polite in front of your partner right now? I said next time. On the wild bus home fights nearly broke out about seating arrangements and someone went into the bathroom to smoke what felt like a whole pack of cigarettes. One man spent most of the 4 hour ride on a speakerphone conversation I kept jotting down tidbits of. He was flirt-fighting with a woman baby, what you mean if I smash your friends we can't be friends?...baby I'm trying this "open relationship" shi-t. you ain't even my babymova yet I ain't even nut in you all the way!! ...baby...you love me you stress me, you love me you stress me. A passed out and I tried to drift to a podcast, though we both intermittently woke up to what sounded like phone speaker porn from the self-same row. The train is a significantly more comfortable and even pleasureable experience, but we both agreed that Cecilia would have approved of the whole nasty thing, even the getting dropped off in Baltimore on the dark side of a road off the highway by the bus driver. When I finally got home, I found a naked, undeposited check on the shelf by my back door made out from my father to me, dated 2017 for 50 dollars to help buy my mom a birthday present that year. I've no idea where this could have come from - I haven't even owned my current car that long. Sunday is 2 years since he died. The ghosts feel so active right now, like they're screaming.
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A Thursday afternoon raid of a home child care center in Dover yielded guns, drugs and thousands of dollars in cash, the city's Police Department said.
Members of Dover Police Department's Drugs, Vice and Organized Crime unit raided the home just before 12:30 p.m. as part of an ongoing drug investigation, police said in a Friday afternoon news release. Four children were being cared for at the time of the search.
Two people, a 33-year-old man and a 29-year-old woman, were charged as a result. The man later admitted to dealing drugs out of the home, court documents obtained by Delaware Online/The News Journal show.
The day care center, The Little Peoples LFCC 2, was formed as a Delaware limited liability company in March 2022, according to state business records.
The woman who was charged on Thursday is the company's registered agent. Delaware Department of Education records show it's classified as a "licensed large family child care" that can serve up to 12 toddler through school-aged children.
Why raid the home?
According to court documents, police executed the search warrant days after a detective who was surveilling the street saw the man "conduct what appeared to be a hand-to-hand drug transaction" with another person.
When that person was stopped, they told police that the man had sold them heroin.
Based on that arrest, court documents say, detectives obtained a search warrant for the home, located at 118 Roosevelt Ave. The man was not home at the time of the raid, but the woman was.
In total, officers found two guns, 93 grams of powder cocaine, 26 grams of crack cocaine, 302 bags of heroin and more than $32,200. The woman also had five doses of "suspected MDMA" when she was arrested.
The kids who were being cared for at the time of the raid "were turned over to their guardians," police said.
The man is being held at Sussex Correctional Institution on numerous gun and drug charges, while the woman posted $49,700 secured bond Friday morning, court records show.
She was also charged with gun and drug crimes.
What we know about the day care
According to Department of Education records, the child care center has been operating since at least 2021. The first compliance review was on March 16 of that year, when an Office of Child Care Licensing employee found it to be "non-compliant" in four areas.
The issues noted by the inspector included: "trash and debris" in an outdoor play area; non-documentation of fire prevention inspections and evacuation drills; use of a non-approved OCCL vehicle to transport children; and a lack of a state business license.
These were all listed as "corrected."
The facility was again inspected six months later, in September 2021. That time, a licensing employee told the owners to repair a gate to ensure it self-closes and self-latches, ensure annual inspections of fire extinguishers and ensure the license renewal application is submitted 60 days before it expires.
It's unclear if the renewal referred to the state of Delaware business license or the license to operate a child care center.
In September 2022, another inspection was completed. This time, inspectors found several indoor and outdoor repairs needed to be made, the license renewal again needed to be submitted at least 60 days before expiration and several other minor issues. Like before, these were later listed as "corrected."
The most recent inspection was Sept. 6, 2023, when an inspector again noted that outside gates needed to self-close and self-latch. That was corrected on Sept. 21, records show.
Only two other issues were found during that inspection: Two children did not have blood lead screening results in their files and one didn't have a health appraisal or immunization record, and the owners were asked to update the parent handbook to include an updated release of children policy.
These were listed as "corrected" on Sept. 20.
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Australia is the first country to let patients with depression or PTSD be prescribed psychedelics
Beginning Saturday, Australian physicians can prescribe doses of MDMA, also known as ecstasy, for PTSD. Psilocybin, the psychoactive ingredient in psychedelic mushrooms, can be given to people who have hard-to-treat depression. The country put the two drugs on the list of approved medicines by the Therapeutic Goods Administration. Scientists in Australia were surprised by the move, which was…
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I'm watching Sex Education season 4. I love this show, it is great. But I have just seen something that made my addiction nurse brain so happy.
There's a scene in ep 3 where a bunch of the main characters go to a club and pills are offered out. One says he has never one them before and is a bit scared. One of the others says she is "not doing them tonight" and will look after him. So he feels safe try it.
Now. Club drugs have become, progressively, more dangerous and mixed with awful and more toxic substances over the last decade or so. This means that the harm redixation advice for these substances is harder to give. So what used to be MDMA is now more likely to be shit like PMMA which is far more dangerous. Is a crap shoot and not good.
BUT! I am very, very impressed at the way this was written. That is *chefs kiss* harm reduction. Make sure there is someone who knows the effects you are looking for but who is not partaking and can look after you.
And it was done so naturally!
And the group had a good time. No drama and no one left in an ambulance.
They did feel a bit...awful...the next day but 🤷
Sex Education continues to be better than the social/PSE shit I had in school and I do approve from a professional who literally does harm reduction education on the daily.
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The party drug MDMA earned positive results for treating people living with post-traumatic stress disorder, according to a new study that confirmed earlier findings.
The new study for the MDMA clinical trial program was completed in November and sponsored by a group called the Multidisciplinary Association for Psychedelic Studies. The trial is part of an ongoing effort to obtain federal approval for use of MDMA in therapy as the number of people suffering from PTSD, mental illness, and opioid addiction continues to climb.
Prior to federal criminalization of the use and possession of MDMA in 1985, the substance had been legally used in therapy treatments for at least a decade. As part of its decision to criminalize MDMA, the Drug Enforcement Administration said abuse of the substance had “become a nationwide problem” and posed “a serious health threat.”
MDMA is only one of a handful of drugs, especially psychedelic drugs, that the federal government considered to be largely for recreational purposes — and therefore illegal — that are now slowly progressing toward government approval for legal uses. The drugs, among them psilocybin, which is found in “magic mushrooms,” are being studied for therapeutic uses.
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New Post has been published on https://bloornews.com/blog-toronto/bc-company-granted-permission-by-health-canada-to-produce-and-sell-cocaine/
BC Company Granted Permission by Health Canada to Produce and Sell Cocaine
A British Columbia cannabis company says it has received approval from Health Canada to produce, sell, and distribute cocaine.
A woman (L) prepares to inject herself with an unknown substance as a man sits in a wheelchair outside Insite, the supervised consumption site, in the Downtown Eastside of Vancouver, B.C., on Feb. 21, 2017. (The Canadian Press/Darryl Dyck
In a news release on Feb. 22, Adastra Holdings Ltd., which produces marijuana for adult use and medical sales out of headquarters in Langley, B.C., announced that it was granted a Health Canada amendment to its Controlled Drug and Substances Dealer’s License on Feb. 17.
The company can now “legally possess, produce, sell and distribute” cocaine, in addition to previously being allowed to deal up to 1,000 grams of psilocybin and psilocin, otherwise known as magic mushrooms.
The news release indicates Adastra can “interact with up to 250 grams” of cocaine, and can import coca leaves to manufacture and synthesize the hard drug in Canada.
Adastra’s Health Canada approval follows a federal government approval for B.C. that, as of Jan. 31, granted the province a temporary three-year exemption to allow adults to legally possess up to 2.5 grams of any combination of opioids, cocaine, methamphetamine, MDMA, heroin, fentanyl, and/or morphine for personal use, at no risk of being arrested, charged, or having their drugs seized.
The CEO of Adastra, Michael Forbes, is a pharmacist who formerly worked in multiple methadone pharmacies, according to the company, and is a proponent of “harm reduction,” which is a philosophy that promotes reducing negative consequences associated with drug use, but without requiring abstinence from drugs or addiction treatment.
Adastra’s release says he previously “piloted a needle exchange program” at the direction of the Centres for Disease Control and Prevention in 2010. Forbes is the creator of the Forbes Group, which has multiple companies ranging from moving storage, cannabis, health care services, and advertising.
The federal government has been supportive of the B.C. decriminalization plan, with federal Mental Health and Addictions Minister Carolyn Bennett saying on Jan. 30 that it will reduce “the stigma, the fear, and shame that keep people who use drugs silent about their use, or using alone.”
Conservatives have been critical of the plan, with leader Pierre Poilievre saying B.C.’s approach to the issue has been an “abject failure.”
“Decriminalization has been in place in B.C. now since about 2017 in reality,” he said on Feb. 1. “The results are in. The debate is over. It has been a disaster, an absolute abject failure.”
By Marnie Cathcart
#Around Town#articles#breaking news#current events#daily news#health condition#In Your Neighbourhood#latest news#local news#new#news article#newspaper#newspaper articles#recent news#tribune
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synthetic Bath salts
Much is still unknown about how synthetic cathinones affect the human brain. Researchers do know that synthetic cathinones are chemically similar to drugs like amphetamines, cocaine, and MDMA.
A study found that 3,4-methylenedioxypyrovalerone (MDPV), a common synthetic cathinone, affects the brain in a manner similar to cocaine, but is at least 10 times more powerful. MDPV is the most common synthetic cathinone found in the blood and urine of patients admitted to emergency departments after taking bath salts.
Are synthetic cathinones addictive?
Yes, synthetic cathinones can be addictive. Animal studies show that rats will compulsively self-administer synthetic cathinones. Human users have reported that the drugs trigger intense, uncontrollable urges to use the drug again. Taking synthetic cathinones can cause strong withdrawal symptoms that include:
depression
anxiety
tremors
problems sleeping
paranoia
How can people get treatment for addiction to synthetic cathinones?
Behavioral therapy can be used to treat addiction to synthetic cathinones. Examples include:
cognitive-behavioral therapy
contingency management, or motivational incentives—providing rewards to patients who remain substance free
motivational enhancement therapy
behavioral treatments geared to teens
As with all addictions, health care providers should screen for co-occurring mental health conditions. While there are no FDA-approved medicines for synthetic cathinone addiction, there are medicines available for common co-occurring conditions.
"Bath salts" are made in illegal laboratories. The crystalline powder is sold:
as capsules or tablets
in small plastic or foil packages
They are also known as:
drone
MCAT
vanilla sky
blue magic
bath powder
In an attempt to conceal them, these illegal drug products are usually mislabelled as:
fine china bath salts
not for human use
“Bath salts” get their name from their powder form. The white or brown powder looks like the salts you put in bath water, such as Epsom salts.
They can be taken in different ways:
sniffed into the nose (snorted)
dissolved in liquid and swallowed
wrapped in cigarette paper and smoked
dissolved in liquid and injected into the vein
“Bath salts” stimulate the central nervous system to:
improve mood and sociability
increase alertness and energy
However, using them may lead to severe adverse effects or even death.
The most common substances in “bath salts” are synthetic forms of plant-based cathinones. Almost all synthetic cathinones are controlled under Schedule I of the Controlled Drugs and Substances Act.
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Lykos Therapeutics recently encountered a significant setback when the FDA denied approval for MDMA-assisted therapy for PTSD, issuing a complete response letter that requested further studies to evaluate the treatment's safety and effectiveness. Lykos CEO Amy Emerson described the decision as "deeply disappointing," especially given the growing support for the therapy among patients and veterans' organizations who highlight the urgent need for effective PTSD treatments! Critics of the FDA's decision (including Dr. Boris Heifets from Stanford) argue that the agency's concerns were overblown and that data that already exists could appropriately address its issues without requiring yet another lengthy trial. Despite the disappointment, experts like Dr. Mason Marks maintain that the FDA remains open to psychedelic research and that this specific case may not hinder the broader movement toward psychedelic therapies. Lykos plans to request a meeting with the FDA to explore potential pathways forward, and there is a theory that the decision may create an opportunity for other psychedelics, like psilocybin, to advance toward approval more swiftly.
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