FDA Approves Non-Opioid Drug to Treat Opioid Withdrawal Symptoms
The US Food and Drug Administration (FDA) has approved Lucemyra (lofexidine hydrochloride) to treat opioid withdrawal symptoms in adults. This drug may lessen the severity of withdrawal symptoms; however, it may not prevent them.
Lucemyra is only approved for a treatment period of up to 14 days. The medication is not meant to be used as a treatment for opioid use disorder (OUD). It’s one part of a long-term treatment plan for patients with OUD.
Opioid Withdrawal Symptoms
When someone has been taking opioids over a period of time, he will develop a physical dependence on the drugs. This is to be expected, and doesn’t necessarily mean that a patient has become addicted to the medication. Withdrawal symptoms can occur in patients who have been using opioid pain medications as directed by their doctor and people with OUD.
For patients taking opioid pain medications as directed by a doctor, opioid withdrawal is typically managed by slowly tapering off the drug. This strategy is used to lessen the effects of withdrawal symptoms. Some patients are able to avoid experiencing withdrawal symptoms entirely.
In a patient with OUD, withdrawal is typically treated by substituting another opioid medication. In time, the dose is gradually reduced or the patient is switched to a maintenance therapy program. These medication-assisted therapy (MAT) treatments may use drugs like methadone, buprenorphine or naltrexone. Medications may be prescribed to treat specific symptoms, such as aches and pains or stomach upsets.
Lucemyra is taken orally and works by reducing the release of the brain chemical norepinephrine. Its actions are believed to play a role in several opioid withdrawal symptoms.
When an addiction sufferer realizes they have a drug or alcohol problem, the decision to stop using is a tremendous first step. However, for a number of reasons sufferers may choose to attempt the detoxification process by themselves.
Drug or alcohol addicts may be ashamed of their use, afraid to share their addiction, or simply may not know where to turn. Unfortunately going through detoxification alone may be more detrimental to the long-term health of the sufferer than not coming clean in the first place.
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Physical Withdrawal from Drugs or Alcohol
The sickness and physical pain caused by withdrawal symptoms often get the better of those attempting to self-detox. The body has become accustomed to functioning with the addictive substance. Organs and the brain have figured out ways to accommodate and flush toxic chemicals from the body.
But, once the addictive substance has been removed, the body doesn’t adjust as quickly. This results in unpleasant physical side effects including:
In the most severe cases, seizures, heart palpitations, and other life-threatening conditions can occur. The possibility of withdrawal resulting in permanent health issues or even death should be reason enough to see medically supervised detox.
With medical supervision and intervention, physicians may be able to introduce medications which can assist in reducing physical symptoms. Fear of replacing one drug with another should be eased. Medically supervised detox can require daily or even weekly supervision. Thus reducing the unlikely development of a secondary addiction.
Mental Obstacles in Detox from Drugs
Patients seeking to detox should not only seek out medical solutions but, mental and therapeutic support. While the physical discomfort of withdrawal can be severe, in some instances the mental anguish associated with withdrawal can become too much to bear for some individuals.
During the detox process, suffers can experience mental symptoms including:
Feeling of hopelessness
Intense desire to use again
Detoxifying can be a psychologically taking ordeal. Having access to the proper level of both medical and mental therapeutic support significantly increase the chances for success.
The Benefits of Medically Supervised Detox
The detox process is similar to other medical treatments. First, the addiction is identified and evaluated. Once understood, the proper treatment plan can be put in place. Finally, and perhaps most important, follow up treatment and assessments help ensure a successful recovery.
Medically supervised detox provides the same benefits as other treatments, such as physical therapy or surgery including:
Professional medical and therapeutic staff
Clean, safe, and supportive environments
Expert symptom relief
Physicians and nurses specially trained in addiction-related treatments can alleviate withdrawal symptoms. They also know when to intervene in an emergency or when to change course if outcomes are not meeting expectations.
Rehabilitation and recovery centers provide a safe environment for sufferers. Surrounded by knowledgeable staff at all levels, comfort and privacy are provided for even the most vulnerable moments of the detox process.
What to Expect During Detox
One of the first questions asked is how long an average detox program can last. There are several factors which determine how long addiction sufferers may spend in a program:
Frequency of use
Underlying medical conditions
Use of single or multiple substances
How long drugs or alcohol have been abused
Typical stays last from a few days to a couple weeks. Keep in mind this is only the inpatient treatment portion of the program. Participants will be expected to make regular physician visits and are encouraged to commit to therapy sessions or support groups.
During the time at the rehabilitation center, expect to be surrounded by around the clock care from doctors, nurses, and therapists. Upon entering the center, physicians will establish a medical baseline of health and uncover any medical conditions you may have.
With around the clock monitoring, vitals are checked on a regular basis. As much rest as needed is provided. Each day medications are adjusted appropriately to assist in the detox process. Ultimately the goal is to get addicted suffers back to being themselves as soon as possible.
In most instances, it is recommended clients seek continued monitoring. In addition to returning home with the support of friends and family, after detox treatment programs greatly reduce the chance of relapse.
As supportive as friends and family may be, trained professionals can help with unique physical and mental after-effects addiction sufferers may experience. The support in treatment programs provides a source of comfort while adjusting to sober living.
The importance of medical supervision during the detox process cannot be stressed enough. Medically supervised detox is the safest and best step anyone can take to rescue their life from addiction. If you or someone you know requires detox, there are many organizations including Desert Cove Recovery who can provide the best possible detox options.
Opiates are addictive in part because they activate parts of the brain associated with pleasure. However, that is only part of the story. A person who takes painkillers or other opioids will find themselves chemically dependent on the drugs. Once this happens, overcoming addiction can be extremely difficult. The physical and emotional withdrawal symptoms pose a tremendous challenge to individuals looking for recovery.
How Opioids Work in the Brain
Your body naturally produces opioids, which attach to special receptors in the brain. These neurotransmitters help the body naturally regulate pain and stress.
Chemical opioids attach to the same receptors in the brain and have a similar effect of producing euphoria. However, they are significantly stronger than anything the body can produce on its own. These fake neurotransmitters flood the system and eventually prevent the body from producing opioids of its own. Part of what causes drug withdrawal symptoms is this lack of dopamine and related chemicals in the brain as the body adjusts to the absence of opioids.
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Stages of Opiate Withdrawal: A Timeline
Drug withdrawal presents a set of physical and emotional symptoms that can be extremely difficult to endure. However, it’s important to remember that withdrawal is temporary.
If you or a loved one is facing detoxification and rehab, know that the worst of the symptoms will last just a few days. Knowing what to expect and having a timeline of events in mind can help to ease some of the psychological pressure when facing withdrawal and recovery.
Withdrawal symptoms for short-acting opiates will begin within 12 hours of the last dose. For long-acting opiates, symptoms may start within 30 hours. Over the next two days, symptoms will continue to worsen, peaking around the 72 hour mark. By the end of the third day, most physical symptoms will have resolved. Psychological symptoms and cravings may continue for a week or more.
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Early withdrawal symptoms include the following:
Agitation or anxiety
Sweats and fever
Increased blood pressure and heart rate
These initial symptoms may cause restlessness and mood swings.
The later stage of withdrawal produces flu-like symptoms:
Nausea, vomiting or diarrhea
Goosebumps and shivering
Stomach cramps and pain
Depression and intense drug cravings may accompany this stage. These symptoms will generally peak within 72 hours and resolve within five days. From a physical standpoint, recovery is well underway. Physical symptoms of withdrawal may disappear quickly after the third day of detox. However, psychological symptoms may linger, and drug cravings may persist or come and go in the weeks and months that follow.
What About Drug Replacement?
In some cases, an alternative substance like Suboxone may be provided to help mitigate the effects of chemical dependence. This drug is classified as a “partial opioid agonist,” which means that it is a weaker type of opioid that cannot be abused. Other replacement drugs, like methadone, may also sometimes be used.
Addiction clinics and rehab facilities offer these medications as a stepping stone to help reduce the severity of drug withdrawal symptoms. However, users will still undergo withdrawal when weaning off of the replacement drug, and recovery will take longer when these medical aids are offered. There is also the risk of finding a way to abuse these medications.
The Importance of Support During Withdrawal
Drug detox and addiction recovery services are crucial to helping people recover safely throughout the stages of opiate withdrawal and stay away from drugs long-term.
One important but often overlooked symptom of withdrawal is suicidal ideation. Not everyone who undergoes withdrawal feels suicidal, but the feelings of depression can be overwhelming. People in the grip of withdrawal may experience mood swings and dark thoughts that seem to have no end point. The feeling that life may never be better than it is in that dark moment or that the addict can never be happy again without drugs can be overwhelming. For this reason, a strong support system is essential to the safety of people overcoming addiction. Recovering addicts need to know that their symptoms are temporary. They also need to be protected from opportunities for self-harm and relapse.
Protecting recovering addicts from relapse is especially important because many deadly overdoses occur during relapse. Because the user’s body is no longer accustomed to the drug, it will be more sensitive. What would have been a normal dose for the user before withdrawal can become a deadly overdose in the weeks that follow.
The best drug rehabilitation programs provide a strong support network for recovering addicts throughout all stages of recovery, including the difficult weeks that follow acute drug withdrawal. By continuing to offer support after the initial symptoms have faded, the rehab program can provide the best environment for successful and permanent drug cessation.
There continues to be a high demand for medication-assisted treatment (MAT) for opioid addiction. To date, however, states like Ohio only haveabout two percent of doctors that have completed the training necessary to prescribe or dispense buprenorphine. This is the main ingredient in the addiction treatment drug Suboxone, and other similar medications.
Plan to Double Healthcare Professionals Providing Buprenorphine
The state is planning to double the number of healthcare professionals certified to provide Suboxone (and other addiction treatment medications) to patients over the next 18 months. The federal government has provided $26 million in grant funding under the 21st Century Cares Act so that more healthcare providers can get training. Under existing law, doctors, as well as nurse practitioners and physician assistants (PAs) can dispense buprenorphine.
Waiver to Treat Patients for Opioid Addiction
Under the Drug Addiction Treatment Act of 2000 (Data 2000), doctors can apply for a waiver allowing them to treat patients with buprenorphine in their office, clinic, a community hospital or “any other setting where they are qualified to practice.” To qualify for a physician waiver, a doctor must be:
• Licensed under state law • Registered with the DEA (Drug Enforcement Administration) to dispense controlled substances • Agree to treat a maximum of 30 MAT patients during the first year • Qualify to treat MAT patients, either by training or by professional certification
A doctor who has completed at least eight hours of classroom training focused on treating and managing patients with opioid use disorders can qualify for a waiver. The new training program for medical professionals is 1.5 days of classroom instruction, and participants are expected to continue their education through online courses and seminars.
Medication-Assisted Treatment Growing in the United States
The National Institutes of Health Studies says that MAT is a very effective method for treating opioid addiction. Studies conducted in 2014 revealed improved long-term recovery rates over traditional treatment methods, though it often takes finding the perfect balance for each individual as to how long they stay on the medication. Ideally, they would work toward being off of it in 2 years or less, and many people seek to use Suboxone for short-term tapering to simply ease opiate withdrawal symptoms.
The Food and Drug Administration (FDA) has given its approval for a specialized tool that will be used to help US patients addicted to prescription pain medications and get them off opioids.
The newly-approved device delivers electric pulses to the area behind the patient’s ear. This electric pulse triggers a current which travels to the person’s occipital nerves (the ones reaching from the spinal cord to the back of the neck) and cranial nerves. It functions as a PNFS (Percutaneous Nerve Field Stimulator) device system and stimulates the patient’s brain to mask opioid withdrawal symptoms.
This medical device has been named the NSS-2 Bridge (NSS stands for “Neurostimulation System”.) Research shows that when used over a five-day treatment period, the process can be effective. The device is used during the period when an opiate-dependent person is likely to experience the most intense pain, as well as body tremors and sweating, during withdrawal.
Seventy-three patients were involved in the trials to determine the device’s effectiveness. Close to one-third (31 percent) of the participants noticed a reduction in symptoms within half an hour of getting the device. The trial found that 64 of the patients got relief and were ready to move forward to medication-assisted therapy after using the device. This represented a success rate of 88 percent after the five-day trial. However, other applications may include permanent abstinence rather than switching to a maintenance drug.
The FDA has decided to approve the device, even though the results of the study are limited. Further trials will be undertaken to evaluate its effectiveness in various settings.
FDA Commissioner Scott Gottlieb stated in his reasons for approving the new device that there is a need for finding new ways of helping people who are addicted so that they can achieve sobriety with “medically assisted treatment.” He went on to say that while research is continuing to find better medicines to treat opioid use disorder, medicine also needs to look to devices to help as well.
Finding alternative methods of treating opioid dependency is a major topic of discussion regarding dealing the epidemic our nation faces. In addition to helping people get off these drugs, it is imperative to find more ways to reduce or avoid using these highly addictive substances.