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The woman had used oxycodone for almost a decade but told her doctors she had been sober for two years. She never touched narcotics during her pregnancy, she said, and had completed rehab.

But her newborn son was in withdrawal: jittery, screaming and requiring an infusion of morphine to stay alive. The infant craved drugs, but why?
Amid an opioid epidemic, the boy’s doctors didn’t blame heroin, fentanyl or other illicit substances. Instead, they said, the infant had grown dependent on a controversial herbal supplement: kratom.

‘A false sense of safety’

According to a case report published Wednesday in the journal Pediatrics, both the unnamed woman and her infant passed urine drug screens that looked specifically for oxycodone and other opioids. But those tests didn’t look for kratom, a legal drug that has opioid-like effects at high doses.
close dialog
The plant, which is native to Southeast Asia, is typically used to treat pain and curb opioid cravings. Acting on the same brain receptors as morphine and similar drugs, it is hailed by someas a solution to the opioid epidemic but derided by the US Food and Drug Administration as a potentially dangerous psychoactive drug.
The mother denied using any substances during her pregnancy — legal or otherwise — but her husband told doctors that she drank kratom tea daily to treat her withdrawal symptoms and help with sleep.
“I fear that women making genuine commitments to overcome their dependency may develop a false sense of safety by using a substance that is advertised as a non-opioid alternative,” said Dr. Whitney Eldridge, a neonatologist for BayCare Health System in Florida who was lead author on the case report.
The mother might have been well-intentioned, but because tests showed no other drugs in her or the infant, her doctors said kratom probably caused her son’s condition, known clinically as neonatal abstinence syndrome. On his eighth day of life, after he had been weaned off opioids and observed without any medications, the boy was discharged to his parents.
It’s rare, but FDA Commissioner Dr. Scott Gottlieb said in a statement that “this case is not unique.” He said the FDA “is aware of four other cases involving neonates exposed to kratom while in utero who experienced neonatal opioid withdrawal syndrome after term delivery.”
Gottlieb, whose agency has issued a variety of warningson kratom, called the new report “a tragic case of harm” and said it “further illustrates the concerns the FDA has identified about kratom, including the potential for abuse and addiction.”
And though Eldridge hopes more research will help lawmakers better regulate kratom, she believes that physicians today “need to counsel women who are pregnant about the risk of kratom such as they would any other legal substance that can have ill effects on their newborn.”

Experts urge caution, cast doubt

Some experts are hesitant to draw any conclusions from the report. They note that although maternal kratom use could theoretically cause neonatal abstinence syndrome, the case did not explicitly link kratom to the infant’s withdrawal symptoms.
“I’m not surprised that this is possible,” said Dr. Andrew Kruegel, an associate research scientist at Columbia University, “because kratom certainly has opioid effects and can induce tolerance in users, especially at higher doses.”
But Kruegel, who has studied the plant for seven years, noted that doctors weren’t able to test the purported kratom itself. “The main limitation is that we don’t know anything about the dosage that the mother was taking,” he said. “Without that information, you can’t really extrapolate too much.”
And the mother might not have been taking kratom at all, said Dr. Edward W. Boyer, an associate professor at Harvard Medical School and a physician in the Department of Emergency Medicine at Brigham and Women’s Hospital.
“It’s the husband who reported the kratom use,” he said. “The wife who actually ingested the product, who thought it was kratom, and the authors of the case report itself, none of those people actually verified that she was ingesting kratom.”

Kratom’s rocky past and uncertain future

Despite the FDA’s warnings, kratom is easy to buy and is sometimes sold as a tea in cafés. The nonprofit American Kratom Association estimates that 3 million to 5 million Americans use the substance, and the group says it’s open to warning labels on kratom products.
“We believe that, as in many supplements, there should be a warning that pregnant women shouldn’t take this,” Dave Herman, the association’s chairman, said. “That’s not because we think it’s detrimental. It’s because it’s a safety measure.”
Kratom acts on opioid receptors, which the FDA says is evidence of its potential for abuse. The agency points to 44 deaths associated with kratom, but Kruegel said that “if you look at those 44 deaths, the vast majority of them involve other substances, including other strong opioids.”
Boyer said kratom may have other risks, such as seizures, but he noted that it might be safer than most opioids because “there does not seem to be respiratory depression when kratom is used alone.”
Respiratory depression — slow and ineffective breathing — is what makes opioid overdoses so deadly. That’s why Boyer believes well-regulated kratom could one day be used in the fight against opioid addiction, steering users away from more dangerous drugs.
“If you do the right thing and do the rigorous studies, then there is no reason why [kratom] shouldn’t be a prescription pharmaceutical that serves as a bridge to formal drug treatment, particularly for individuals who can’t get into therapy,” Boyer said.

Challenges to developing kratom-based drugs

The American Kratom Association says there’s little incentive for pharmaceutical companies to study kratom as a potential prescription drug, especially because they can’t patent the raw plant.
“If I’m a drug company, I think that it costs somewhere, depending on who you speak to, between $1.2 and $1.8 billion to bring a new drug to market,” Herman said. “Who would spend that kind of money when some other guy can just get on a boat, ride down a river and grab it off a tree?”
Because kratom is considered a dietary supplement, manufacturers don’t need FDA approval to sell it as long as their products don’t claim to cure or treat specific conditions or symptoms.
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But some companies have done just that, drawing the FDA’s ire for saying their products could “relieve opioid withdrawal” or “treat a myriad of ailments.” The association says those cases are anomalies.
“The reality is, our belief is, this is America,” Herman said. “And if a product is useful for your health and well-being, you should have the right to take it, as long as it doesn’t harm you. And we haven’t seen any evidence of that harm.”
The FDA, however, continues to warn against kratom, even suggesting that it could worsen the opioid epidemic.
“Kratom has never been studied in humans,” Gottlieb said in the statement. “What consumers and health care providers need to understand is that there are no proven medical uses for kratom. Instead, as the FDA has warned, kratom can cause serious harm and is contributing to the opioid crisis.”

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NOVA Addiction Specialists website – Suboxone and telemedicine treatment in Alexandria, Virginia 703-844-0184

Dr. Sendi – at NOVA Addiction Specialists can evaluate you to see if Sublocade will work for you.

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Suboxone treatment in Alexandria, Virginia 703-844-0184

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Blocking microglial pannexin-1 channels alleviates morphine withdrawal symptoms

Opiates are essential for treating pain, but termination of
opiate therapy can cause a debilitating withdrawal syndrome
in chronic users. To alleviate or avoid the aversive symptoms
of withdrawal, many of these individuals continue to use
opiates1–4. Withdrawal is therefore a key determinant of opiate
use in dependent individuals, yet its underlying mechanisms
are poorly understood and effective therapies are lacking. Here,
we identify the pannexin-1 (Panx1) channel as a therapeutic
target in opiate withdrawal. We show that withdrawal from
morphine induces long-term synaptic facilitation in lamina I
and II neurons within the rodent spinal dorsal horn, a principal
site of action for opiate analgesia. Genetic ablation of Panx1
in microglia abolished the spinal synaptic facilitation and
ameliorated the sequelae of morphine withdrawal. Panx1
is unique in its permeability to molecules up to 1 kDa in size
and its release of ATP5,6. We show that Panx1 activation
drives ATP release from microglia during morphine withdrawal
and that degrading endogenous spinal ATP by administering
apyrase produces a reduction in withdrawal behaviors.
Conversely, we found that pharmacological inhibition of
ATP breakdown exacerbates withdrawal. Treatment with
a Panx1-blocking peptide (10panx) or the clinically used
broad-spectrum Panx1 blockers, mefloquine or probenecid,
suppressed ATP release and reduced withdrawal severity.
Our results demonstrate that Panx1-mediated ATP release
from microglia is required for morphine withdrawal in rodents
and that blocking Panx1 alleviates the severity of withdrawal
without affecting opiate analgesia. 

Could This Inexpensive Medication Reduce Your Withdrawal Symptoms?

Could This Inexpensive Medication Reduce Your Withdrawal Symptoms?

Withdrawal. It’s a huge hurdle on the path to recovery.

Those struggling to leave opioids behind know they’ll eventually have to face the intimidating mental and physical effects of withdrawal. It’s a powerful and frightening thought.

Some of the most common withdrawal symptoms include:

  • Muscle aches and cramps
  • Nausea, vomiting, and diarrhea
  • Anxiety, profuse sweating, and restlessness
  • Blurry vision
  • High blood pressure

Help Where It’s Needed Most

Even though millions of Americans are in the midst of this battle, few medications are available to effectively manage their symptoms. This unavailability – and the onset of painful withdrawal symptoms – are often enough to make many people give up and return to opioids for relief.

But this could soon change…

According to the results of a recent study, help for intense withdrawal symptoms might be on the horizon, thanks to the discovery of a new drug.

“Opioid withdrawal is aversive, debilitating, and can compel individuals to continue using the drug in order to prevent these symptoms,” explains lead researcher Tuan Trang, PhD.

“In our study, we effectively alleviated withdrawal symptoms in rodents, which could have important implications for patients that may wish to decrease or stop their use of these medications.”

The Study

Researchers from the University of Calgary’s Faculty of Veterinary Medicine and Hotchkiss Brain Institute investigated the process of withdrawal and its’ possible causes. The study involved rats which had been given two potent opioids, morphine and fentanyl. The team identified the glycoprotein, pannexin-1, as the source of withdrawal symptoms in rodents. Pannexin-1 is also located throughout the human body, including the brain and spinal cord.

After identifying the cause of these symptoms, the team tested a drug already proven to block the effects of pannexin-1 called, Probenecid. It’s an anti-gout medication that’s fairly cheap and has few side effects.

The results showed this medicine was “effective in reducing the severity of withdrawal symptoms in opioid-dependent rodents.” Another encouraging aspect about their findings: the medication didn’t affect an opioids’ ability to relieve pain.

Previous research hadn’t explored this avenue, and this investigation has provided a better understanding of opioid withdrawal at the cellular level.

The Implications

Canadian pain researcher, Dr. Michael Salter, notes, “This is an exciting study which reveals a new mechanism and a potential therapeutic target for managing opioid withdrawal. The findings of Dr. Trang and his team could have important implications for people on opioid therapy and those attempting to stop opioid use.”

The team behind the study plan to continue their work and hope this new insight will lead to the creation of a more effective treatment method for the symptoms of withdrawal. Dr. Trang says their next steps will be to determine the drug effectiveness in humans and to ensure its’ safety. Their goal is to develop an effective method to treat the millions struggling with pain management and opioid dependency across the nation and around the world.

These results have already lead to the development of a clinical trial at the Calgary Pain Clinic.

 

FDA approves first medication to reduce opioid withdrawal symptoms

Announcement

May 16, 2018

LofexidineCourtesy of US WorldMeds, LLC.

The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, is pleased to announce that lofexidine, the first medication for use in reducing symptoms associated with opioid withdrawal in adults, has been approved by the U.S. Food and Drug Administration. Lofexidine, an oral tablet, is designed to manage the symptoms patients often experience during opioid discontinuation. Opioid withdrawal symptoms, which can begin as early as a few hours after the drug was last taken, may include aches and pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning, and feeling sick, among others. The product will be marketed under the brand name LUCEMYRATM.

In 2016, more than 42,000 people died from an opioid overdose, or approximately 115 people per day. Although effective treatments exist for opioid addiction, painful and difficult withdrawal is one of the reasons treatment fails, and relapse occurs. By alleviating symptoms associated with opioid withdrawal, LUCEMYRA could help patients complete their discontinuation of opioids and facilitate successful treatment. To date, no other medications have been approved to treat opioid withdrawal symptoms.

LUCEMYRA will be marketed by US WorldMeds, a specialty pharmaceutical company that acquired a license for lofexidine from Britannia Pharmaceuticals in 2003. NIDA provided funding to US WorldMeds to support clinical trials to document the clinical pharmacokinetics of lofexidine and to test medical safety and efficacy of the medication, as compared to a placebo, among patients undergoing medically supervised opioid discontinuation. LUCEMYRA is expected to be commercially available in the United States in August 2018.

Read FDA press release: FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

Read NIDA Director Dr. Nora Volkow’s blog: NIDA-Supported Science Leads to First FDA-Approved Medication for Opioid Withdrawal

For more information about opioids, go to the Opioids webpage. For information about treatment approaches for drug addiction, go to Treatment Approaches for Drug Addiction.

Medication for Opioid Withdrawal

 

May 16, 2018

Image of drug Lucemyra (Lofexidine)Courtesy of US WorldMeds, LLC

In 2016, 115 Americans died every day from an overdose involving prescription or illicit opioids. Addiction to any drug has multiple components—altered functioning of the reward system, learned associations with drug cues that promote preoccupation and craving, and changes to prefrontal circuits necessary for proper exertion of self-control. But physiological and psychological withdrawal symptoms play a major role in driving users repeatedly back to the drug, despite efforts to stop using.

Withdrawal is notoriously hard to endure for people addicted to opioids. Physical symptoms can start a few hours after last taking the drug and may include stomach cramps, aches and pains, coldness, muscle spasms or tension, pounding heart, insomnia, and many others. These symptoms, along with mood changes, like depression and anxiety, are a major reason people with opioid addiction may relapse. Yet until now, no medication has been approved to treat withdrawal.

This week, the Food and Drug Administration (FDA) approved lofexidine, the first medication targeted specifically to treat the physical symptoms associated with opioid withdrawal. NIDA’s medications development program helped fund the science leading to the drug’s approval. Lofexidine could benefit the thousands of Americans seeking medical help for their opioid addiction, by helping them stick to their detoxification or treatment regimens.

Two of the three FDA-approved medications to treat opioid use disorder, methadone and buprenorphine, can be initiated while a person is experiencing withdrawal symptoms, and can help curb craving. However, these medications are not always easy to access, and at this point are only received by a minority of people with opioid use disorder. The third FDA-approved drug, extended-release naltrexone, has also been found effective, but only after people have been fully detoxified.  The need to detox first—and endure those symptoms—prevents many patients from being treated with naltrexone. Lofexidine could make a big difference in making the latter treatment option more widely used.

New Nonopioid Med Blunts Drug Withdrawal Symptoms  < Medscape

Lofexidine is not an opioid. It acts to inhibit the release of norepinephrine in the brain and elsewhere in the nervous system. It was originally developed as a medication for hypertension, but has mainly been used for opioid withdrawal in the United Kingdom since the early 1990s. US WorldMeds acquired a license for lofexidine from Britannia Pharmaceuticals in 2003 and will market it in the US under the brand name LUCEMYRATM beginning this summer. NIDA helped fund the clinical trials to test lofexidine’s pharmacological properties, safety, and efficacy in patients who were discontinuing opioid use under medical supervision.

Lofexidine cannot address the psychological symptoms of opioid withdrawal; further research is needed to develop medications that could address mood problems during detoxification and after. But approval of the first medication to treat the physical symptoms of opioid withdrawal is a major milestone, one that could improve the lives and treatment success of thousands of people living with opioid addiction. And by helping prevent relapse, it could save lives. The approval of lofexidine is also a welcome example of the power of public-private collaborations in developing new treatments.

MIAMI — Lofexidine (Lucemyra, US Worldmeds), which has been in use in the United Kingdom for more than 20 years, is now
available in the United States. The drug is used in the management of symptoms of severe opioid withdrawal.
Dr Danesh Alam
In a double-blind, placebo-controlled, multicenter trial in opioid-dependent patients, lofexidine significantly improved opioid
withdrawal symptoms and significantly increased completion of a 7-day opioid discontinuation treatment program compared with
placebo.
“We desperately need something to address the opioid crisis, where we are losing about 100 Americans every day, with some
16 million on opioids,” Danesh Alam, MD, Northwestern Medicine Central Dupage Hospital, Winfield, Illinois, told Medscape
Medical News.
“Now we have a drug that actually enables us to achieve a rapid withdrawal from opioids. When we use lofexidine, we can
literally bring in someone using opioids, give them this drug, and they can immediately stop using opioids,” said Alam.
The study was presented at the American Society for Clinical Psychopharmacology (ASCP) 2018.
A Better Alternative
Currently, the standard of care for the treatment of opioid withdrawl is medication-assisted therapy with buprenorphine (multiple
brands), but many patients wish to stop using opioids completely, Alam said.
“Buprenorphine is essentially another opioid, albeit a designer opioid, but a number of patients object to clinicians saying that
the best evidence is to switch them over to buprenorphine and do buprenorphine for the rest of their life,” he said.
Lofexidine, a selective alpha-2-adrenergic agonist, acts on the central nervous system. Through its effect on the brain stem, it
reduces the symptoms of withdrawal to a point at which they become very tolerable.
“We found in our study that you could basically give patients the lofexidine and stop the opiate. In the majority of cases, the
withdrawal symptoms at that point were mild,” Alam said.
The researchers enrolled 602 men and women aged 18 years or older who sought treatment for dependence on short-acting
opioids. Most were men (71%); the mean age of the patients was 35 years (±11 years).
Most patients (83%) were dependent on heroin.
Participants were randomly assigned to receive placebo, lofexidine 0.6 mg qid (2.4 mg/day), or lofexidine 0.8 mg qid (3.2
mg/day) for 7 days after abrupt opioid discontinuation.
The study assessed the benefit of lofexidine with the Short Opiate Withdrawal Scale–Gossop (SOWS-G), a 10-item inventory of
common opioid withdrawal symptoms in which higher scores indicate worse symptoms; by the percentage of participants who
completed the study; and by use of the Clinical Opiate Withdrawal Scale (COWS), an 11-item inventory of opioid withdrawal
signs and symptoms in which higher scores indicate worse symptoms.

Scores on the SOWS-G were lower for patients treated with lofexidine at both doses compared to patients given placebo (-0.21
for lofexidine 2.4 mg, P = .02; and -0.26 for lofexidine 3.2 mg, P = .003). More patients in the lofexidine-treated group completed
the 7-day trial than in the placebo group (41.5% in the 2.4-mg group (odds ratio [OR], 1.85, P = .007), and 39.6% in the 3.2-mg
group (OR, 1.71; P = .02), vs 27.8% for placebo.
Mean COWS scores were significantly lower on days 1 to 5 for patients in the lofexidine groups than for patients who received
placebo (P < .01).
Good Timing
The most common side effects seen with lofexidine were hypotension, orthostatic hypotension, and bradycardia, but they
resulted in few study discontinuations.
The US debut of lofexidine comes at a crucial time. It was recently granted approval by the US Food and Drug Administration
(FDA), as reported by Medscape Medical News.
This approval came after 17 years of hard work on the part of the National Institute on Drug Abuse (NIDA).