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Opioid Implant – In-Depth Doctor Interview

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Amit Vijapura,M.D., a board-certified psychiatrist and addiction specialist and the medical director of Vijapura Behavioral Health in Jacksonville, Florida, talks about a first-of-its-kind implant to treat opioid addiction.

Interview conducted by Ivanhoe Broadcast News in July 2016.

 

In your practice how bad has the opiate addiction gotten?

Dr. Vijapura: I started practicing in Jacksonville twenty five years ago and I was trained psychiatrist. I started practicing psychiatry, but in the last fifteen years gradually the demand has increased for patients looking for help with their addiction problems. Addiction problems, in the beginning were mixed; some alcohol, some opioid addiction, some marijuana and some cocaine. But in the last five years it has shifted significantly to Opioid addiction. I was able to modify my practice structure and now I am taking care of about sixty percent of patients who are diagnosed or suffering from opioid addiction; and forty percent of patients are diagnosed with psychiatric conditions.

What was that percentage?

Dr. Vijapura: When I started the practice it was maybe ten percent addiction and ninety percent psychiatric diagnosis.

So what would you say are the reasons behind this increase?

Dr. Vijapura: Opioid addiction has increased gradually from fifteen years ago until four years ago, but four years ago it has gone steep incline; increasingly going up. The deaths related to opioid addiction are four times increased compared to four years ago. People are going to emergency rooms significantly more, people are found unconscious in their homes because of opioid addition, so those things are showing us that in this society there is a significant problem. It is a multi-factorial issue; it is not just one factor. But, one of the factors was that Florida was advocating all of the physicians to prescribe pain medicine if anybody comes with a complaint of pain and that has pushed in to more doctors prescribing opioid medicine. Many clinics or private operations came to Florida to develop a “pain clinic” and all they did was prescribe opioid medication for chronic pain. Now those clinics are shut down, thank God. In the last few years the clinics were shut down and we do not have those kinds of operations because of the legal authority and how they manage the situation.

So, were those incompetent four years ago?

Dr. Vijapura: Very much so. We had operations where you have the billboards that say, pain clinic call 800 numbers and you go in and you are just given pain mediation as much as you need. The trend was at that time was that Florida was so liberal compared to other states that we had people driving all the way from Virginia, or Tennessee to come to Florida just to get the pain pills and then drive back; and they were selling those pain pills. Those operations created an increased number of people using opioid drug and then the internet created another source where people were able to order opiate medicine on the internet; they had a large quantity of opioid to sell or consume. An opioid addiction can be triggered by a number of factors, the genetic factor is a big one but genetic factor is like a sleeping dog, if you do not wake them up they are fine. If you have a genetic factor and you never take an opioid you are going to be okay, but, as soon as, you get the first round of taste of opioid you are going to be using opioid more to get the better feeling and that can turn in to an addiction very fast. On the opposite end, if you do not have a genetic factor and somebody gives you a free opioid, there is a good chance that after using it a few times you are not going to care for it. A generic factor plays a big role and that turns the key on.

Dr. Vijapura: Availability of opioid kind of turned the key on for a lot of those genetic factors and people realized that; hey, opioid makes me happy, opioid gives me more energy. I can get out of bed I can do a lot of things. Patients with pain they are able to function, the doctor justify saying that. Well, without opioid they cannot go to work, but I am giving them treatment and they are able to function. But eventually opioid is type of medicine where you develop a tolerance and tolerance means that you need higher and higher dosage to achieve the same results. Whether it is pain, or whether it is energy, or whether it is a good mood and that is where people had to reach a point where doctors are not giving them enough medication and they have to buy medication from the street. That is the cycle of addiction, now there is an environmental factor, also. People who are surrounded by certain environment and everybody around you are using the pill or sharing the pill you are more likely to try the pill. The peer pressure work environment, the home environment, and the street environment; all those things plays out.

Do you think, also, because people view it as being prescribed by their doctor it is not seen as something as serious, or at least it used to not be?

Dr. Vijapura: That was the factor in the beginning that they were prescribed medication by the doctor and they feel like “I am being taken care of and it is okay to take the medicine.” Until they get to a point where the doctor is uncomfortable and the patient is uncomfortable. Now we are starting to recognize the problem and I think the awareness has a lot to do with this and we are starting to see some results from that, but because now we are starting to recognize that as a problem we are seeing the backlash on the other side of that. What happened with all the physicians in Florida who were openly prescribing opioid for the right reason or sometimes for the wrong reason, for profit reason as we talked about? They were kind of given this warning from the state authorities that you are not allowed to do this anymore. They all cut down the “bad clinics”, own by corporations, they are now shut down. The “good clinic”, the doctors who are prescribing for the right reason, they got scared and started controlling how they prescribed opioid. That made it very difficult for those patients who were already addicted and they had to get the supply from somewhere. They tried to get supplies from the internet, from the street and then they found a cheaper way to get the same high, which was “Heroin”. The heroin is cheaper than pain pills, you get a much faster delivery of the medicine and you get a much faster euphoric effect, but it lasts shorter and shorter; so the tolerance buildup on heroin is much quicker. For example, in order to get a one or two pill you have to spend about eighty dollars and to get the bag of heroin you spend five to ten dollars. It is much cheaper on street. The heroin has expanded so much in Florida that in last twenty years, I have not seen this many cases of heroin addiction. In the last two years we have seen so many cases of heroin addiction that we are really concerned about the heroin epidemic in Florida and in Jacksonville.

Is that treated the same way?

Dr. Vijapura: Heroin also is an opioid. The treatment for heroin addiction, as well as, for pain pills is very effective. The treatment is exactly identical. The only thing we have to worry about is the heroin addiction you have to take care of the medical issues also because many of them are sharing needle and they end up having to deal with hepatitis, end up having cardiomyopathy, heart disease, the liver disease and all those kind of problems; so we have to treat them medically also.

Let’s talk about those treatments.

Dr. Vijapura: The Opioid addiction is because of the mu receptors in the brain. Opioid by pills or by heroin stimulates the mu receptors which immediately delivers the dopamine in your brain and gives you a good feeling. Euphoric effect, the “normalizing effect” many times patient calls it. The mu receptors, also, can respond to other type of opioid replacement therapy. The methadone treatment has been around for the last thirty years. Methadone is like replacing one opioid with another opioid but you are giving methadone in such a high quantity that you are saturating all the receptors. The person does not have any more craving or does not have any more desire to go out and look for opioid. Everywhere in Florida we have methadone clinics, which these clinics are highly regulated and they prescribe methadone on a daily basis. But that treatment was not very convenient and it was a questionable affect for a lot of patients because when you use such a high dose of methadone you can have side effects. Patient can have excessive drowsiness, Patient may look like zombie and you do not have a desire to go to work many times. We have investigated and we came up with a replacement for methadone about fifteen years ago. The treatment is called buprenorphine and we have three brand name medications now Suboxone, Zubsolv and Bunavail. They all are a combination of buprenorphine and naloxone. Buprenorphine is partial agonists on the mu receptors. What that means is that it fools the receptors, it gives you a feeling that you are getting opioid but at the same time it blocks the receptors. The blocking effect creates a sealing affect so the patient will not develop tolerance. If you give them Zubsolv one tablet, two tablets, now you have a sealing affect. If somebody wants to take three and four, they do not get any additional highs (Euphoria). So we like using medications like Zubsolv, which is a combination of buprenorphine and naloxone. Suboxone and Bunavail they all do the same thing, but allowing the patient to have this medicine in their system which saturates their receptors so they can function. They do not have to go to clinic every day with the treatment with buprenorphine. You are allowed to go to clinic once a month and the physician has to be well trained to monitor the patient with appropriate counseling and with appropriate blood tests. With the urine drug test and monitoring of their prescription, the person can function and they are not standing in line every day in methadone clinic. This was called office based treatment and that became very popular; and I have been using it for the last fifteen years with great success, but the biggest question with that treatment was how long you can keep the person on that medication. The research did not answer that because the research we had done for up to one year, two years at the most, now we are ten years down the road and many patients who have been very successful taking buprenorphine for ten years without any trouble. They are functioning. They come to my clinic once a month, they take the medication and they function. I am able to reduce the dose of medication and it can go down to a very small dosage, but many of those patients if they try to stop completely they are not feeling good and they are more likely to relapse. Physicians like us are preventing relapses for those patients and that is what this success is. Anything you treat, diabetes or hypertension, your goal is to take away the symptoms to treat the patients; normalize their blood sugar or blood pressure, but also prevent all their complications of the disease. In this disease we are preventing patients of losing their jobs, losing their family and losing their lives. Not having relapse for ten, fifteen years, it’s a huge success for those patients.

Are there other side effects with opioids? Are there side effects of constipation and things like that?

Dr. Vijapura: We have some mild constipation related to buprenorphine treatment, which is effectively treated during the course of the treatment. But it’s so mild, that I rarely have to stop the medication for those patients.

So these patients are on it, they’re still on it?

Dr. Vijapura: Our patients, who are on buprenorphine treatment for ten years or more, when I look at treatment for Major Depression, When I was trained for psychiatry and we had the antidepressant Prozac. We thought that Prozac was going to take it for six months and the patients are not going to need it after few months. Now, twenty five years later, we are training all the psychiatrists and primary care physicians to continue prescribing antidepressant for life. Why, because we think it’s chronic relapsing diseases, which by taking the medication you are doing a good service to those patients. The same thing with opioids; opioid is a chronic relapsing disease. A patient is treated today and if they stop the treatment there is a very high probability of them having a relapse in next six months or twelve months.

You never think of it like that. It is almost an antidepressant for addiction.

Dr. Vijapura: Correct. We are learning a lot about brain chemistry and we know that in brain chemistry something is imbalanced. For Clinical Depression patient something is imbalanced, for diabetes patients something is imbalance. Same thing with addiction; there is something imbalanced, by taking this type of medicine. You are correcting it and you are allowing them to function better in society. I use an analogy of using an umbrella. That you always carry an umbrella with you, you do not know when it is going to rain. Addiction patients if they are on medication and if it rains they are okay and in this case, “the rain means life stress”

A treatment for addiction, could it be treatment for depression?

Dr. Vijapura: Very good question, researchers have looked at that and there are some ongoing studies looking at the aspects of the brain chemistry and mu-receptors stimulation; can it treat depression? We have seen signals. There is no drug approved at this time, but there are companies and who are products looking at the treatment of depression with partial agonists at the neo-receptors.

Is Bupronephrine medication not addicting ?. I was reading that buprenorphine had some concerns and it was getting in to wrong hands.

Dr. Vijapura: Buprenorphine is still classified as an addictive medication (control III substance). A little lower classification compared to opioid and definitely not as addictive as heroin. The fear is that, (Bupronephrine) it can get in wrong hands and it can be addictive. The main thing we have seen is that anybody who is addicted to opioid and if they are given buprenorphine there is a ceiling effect. For example; If give patient two tablets a day patient do not get any Euphoria (High), We are going to find somebody taking ten pills of buprenorphine to get high. The second aspect is when somebody is selling buprenorphine on the street, which is possible, the person consuming it is trying to come off their “high” related to heroin or pain pills and they are using it as a bridge; because they cannot afford the street drugs, they get the buprenorphine and they get minimal withdrawal symptoms. Technically, they are using medication to reduce the severity of the withdrawal symptoms, but we are addressing that concern too. After fifteen years, since Oral use of Bupronephrine now there are drug companies working on products to have the long lasting delivery of buprenorphine without having to take the pills every day. This can address concerned about abuse and diversion of Bupronephrine.

Let’s talk about the implant, how does that work?

Dr. Vijapura: Braeburn Pharamceutical, has received FDA approval to use Probuphine implant for maintanence treatment of Opioid addiction. Probuphine implant is a small size, like a small needle, that is implanted under the skin, subcutaneous; it takes about ten minutes to implant. It takes a very small cut, less than a centimeter cut and those implants are similar to Norplant. It sits under the skin for six months and it gradually delivers the medicine every day, equal dosage, up to six months. The patients who receive the implant do not have to take the medication on a daily basis. That will help physicians not worry about diversion of medication on street. They do not have to worry about somebody taking it more than recommended or less than recommended. We call it noncompliance or diversion or selling it on the street. Diversion and noncompliance, which is a concern and this type of medication, will address that. Probuphine Implant requires a outpatient surgical procedure and it has to be done by a trained physician. It can be done in ten minutes; first we use a local anesthetic, a very tiny needle, the medicine to numb the area. After Implant is done in 10-15 minutes, patient can walk out of the clinic and go to work and have the rest of the day in their hand without any trouble or complication. The bandage is removed in two days. After six months, they have to go back and remove the implant and the removal process can take about twenty to thirty minutes. With the implant procedure you do not get any stitches, you get sterile strips only, but the removal process you may get a couple of stitches. After the implant is done, we recommend each patient to participate in counseling and monthly monitoring visit with a Addiction specialist. After 6 months we will reevaluate every patient for need for additional treatment.  Or they can be re-implanted on other side with the same amount of medication.

Then can that stay on 6 months cycle?

Dr. Vijapura: Correct, so every six months patients can get implanted with probuphine.

So what are the downsides to this?

Dr. Vijapura: The downside of probuphine is that it has to be handled by a trained physician. There will be a limited amount of physicians who can handle it. It is a surgical procedure so some patients are going to be concerned. It is making a little tiny hole in your body so some people are going to be concerned about the cosmetic part. While you have the implant in your system and something happens to you and you need a pain medicine you have to notify the emergency room immediately because while you have the implant and if somebody gives you an opioid pain medicine it is not going to work for pain.

Does that make the opioid work?

Dr. Vijapura: Any types of opioid pain medication are not going to be effective to reduce the pain because Probuphine is a blocker. It blocks the effect of opioid pain medicine. It blocks the euphoric effect, as well as, analgesic effect from pain medicine. These are the downsides that we have to train the patients, emergency room physicians and every doctor out there.

Does buprenorphine also treat pain?

Dr. Vijapura: Possible, there is a big research going on about can buprenorphine help those patients with chronic pain?  Chronic pain patients by definition have pain going on more than six months and now the questionable part is that how much pain is physical and how much pain is coming from your brain (Psychological)? Chronic pain is a huge specialty now and we have so many physicians who are dealing with chronic pain, but chronic pain has a big psychological component also. We think that chronic pain patients are benefiting today from buprenorphine, but many physicians are reluctant to use buprenorphine for chronic pain because the FDA has not granted official approval. Now the pharmaceutical companies have to do further research. Pharmaceuticals will do the research if patent life left for particular medication. Pain specialist physicians and a lot of the researchers suggest that buprenorphine can be an effective modality in chronic pain.

In talking to Sarah Wilson the other day, she believes it is.

Dr. Vijapura: We have a lot of patients who were successfully treated. Many times chronic pain is not a one condition, they have chronic pain and tolerance to opioid; so they start with pain. Then they are given pain medicine which gradually continues to increase the pain which they have to increase the opioid. Those are the cases you take considering opioid addiction/chronic pain, offer them buprenorphine and you get tremendous results. That person you met is a classic example and there are hundreds of them out there.

Let’s talk about Sarah’s case; do you remember when she came to you?

Dr. Vijapura: Yes, so she was responding to and our advertisement for the research. She was dealing with pain, increased amount of opioid usage and she was struggling; her life was in bad shape. She could not function, she was constantly going to doctors who refused to give her the Opioid pain medicine; and she was turning to the street for Opioid. When she enrolled in the research she was very cooperative, she responded extremely well to the buprenorphine short term trial. We were able to convert her to the probuphine and she was cooperative during the trial for the probuphine. She got the implant and also got the implant removed. During the trial she was on the implant, she responded with a positive result, did not touch any opioid. Her urine test came back negative. I mean everything was extremely successful and she completed the research and had chosen to continue to stay on medically assisted treatment. Medically assisted treatment for a long period of time is a recommended strategy for somebody like Sarah.

She said in the beginning that she was taking the opioid; she knew that she was addicted and she just didn’t really know what to do about it. She didn’t want to deal with the pain of the withdrawal coupled with the pain from the chronic pain. Do you find that most people can recognize that they have an addiction or are they in some type of a denial?

Dr. Vijapura: It can be both ways, some people are taking the pain medication and they justify the use of increased amounts of pain medicine; because they feel like it gives me pain relief, “I can get out of bed, I can be a mother, I can be a father and I can go to work”. They are feeling perfectly okay about increasing the amount of pain medication. And the other side, there are patients who get very uncomfortable and they don’t like it. They feel “dirty” inside, they feel like “I’m really doing something wrong, I should be taking only two pills the doctor gives me but my need has increased and I have to take three or four and I don’t like it; but I don’t know what to do about it” It’s a day to day struggle, and every day they struggle with themselves and they have to go back to the doctor and be honest. They report to their Doctor,” this month was bad and I had to take more pain pills than you gave me.”  The physicians are not very well trained when they come out of medical school; they’re not given proper training on addiction. A lot of physicians look at anybody who deviate from their treatment plan are a “problem patient” and they take a very harsh action. Many times Doctor’s will terminate them, which is not fair. These are good people they need help; they need an appropriate diagnosis and appropriate guidance. But physicians immediately look at it as “these patient’s a liar and they are not good for my practice”. Education needs to happen at the physician level and we’re taking a very active role in educating the physicians. We have to educate the patient about how to communicate with the doctor. An example is Sarah, She could as her doctor “I am taking the medicine as you prescribed but that’s not enough and I have to take more and I don’t like it; what else I can do”? The doctors who are properly trained they’re going to have the option and you just have to sometime communicate with the doctor that you are very uncomfortable with the amount of opioid you need.

How big of a role do family and friends play in helping someone who is addicted get help?

Dr. Vijapura: In many of my cases, family and friends played a big role. Fifty percent of the patients came in because the family said “we had it enough, we need help for our child, our husband and our boyfriend” They are looking to get some help. The person going through the cycle of addiction many times they don’t realize how bad they’re doing. But family can recognize. When they don’t have the supply of opioid they’re irritable, they are not coming out of bed, and they’re non-functional. This are all the symptoms described by the family, those patients are more likely to get successful treatment. Many patients who do not have family support or someone who care enough to force them in to the treatment the success rate is questionable.

They had talked about irritable or can’t get out of bed it sounds very similar to depression, are there other signs that family can recognize or any unusual signs?

Dr. Vijapura: Well, if you know your family, your child or your husband, you know that they have a certain level of functioning and a certain level of happiness. When you see that they are changing, they hiding they’re not making eye contact, they are preoccupied with something or that things from the house disappears. In order to support their habit they have to start selling things on the street. We have a lot of family members say, “In my house things are disappearing from the house” and that’s one of the symptoms. That they are spending money on buying drugs and there’s an unlimited amount of spending they have to do to support their habit. But the important thing is change in personality, they’re more isolated and they are constantly hiding something.

You said not making eye contact?

Dr. Vijapura: Not making eye contact.

Why, is that a big one?

Dr. Vijapura: Well, because the person going through the cycle of addiction knows that they’re doing something wrong; and they have to constantly hide themselves in order to support their habit.

What is the first step that family can do then?

Dr. Vijapura: The first step a family can do is identifying the trouble the person is having, try to gently confront them. I said gently, because if you confront them very strongly they’ll disappear. They’ll go an opposite direction, but if you confront them in a supportive way saying, hey, we care about you and we would like you to get help. Then make some phone calls and there are a variety of resources available. But the important resource is identifying the specialist in your area who is trained to deal with addiction. There are very few, there is a society of addiction; it’s American Society for Addiction Medicine. ASAM.ORG is their website; there are a lot of resources on line. We recommend the person looks up available resources and look at the specialists in your town which can guide you. If you look at the television advertisements you’re going to see a lot of advertising for rehab facilities. Now those are privately owned for profit facilities. They can help addiction too, but the catch is that they are going to charge so much more money. many times you don’t have to spend that kind of money if you can get a consultation with an addiction specialist who can recommend you to a local addiction counselor. You can stay at home, you don’t have to go to the facility, you can be treated effectively with the medication and you can get a good counselor. The comprehensive treatment always includes counseling plus medication.

You were saying when people say I can’t afford it, I can’t afford the treatment but they find out they can, they’re actually saving money.

Dr. Vijapura: Every patient that I have treated they feel like they’re running out of money, they don’t have money. When they start the treatment they pay for the treatment, they pay for medication which is not an exuberant amount of money. In two months of receiving treatment, every patient who is able to go back to their productive life, I ask them, what is the one thing, the one big thing that has changed your life? And they say I have more money in my pocket than before. Because one they were going through the cycle of addiction, they were spending so much time and so much money in obtaining drugs. They were not productive at their job, they probably lost their job or they’re on the verge of losing their job and they were spending money from their pocket to buy the drugs on the streets. Cutting that out, stop buying the drugs on the street was a significant saving. For the average patients when I take the interview for the first visit they say, we’re spending anywhere from thirty dollars to three hundred dollars a month. We were shocked to hear the patient was spending a hundred to three hundred dollars a day to purchase the opiate on the street.

Is there anything else you want to add?

Dr. Vijapura: The important thing is that addiction is a medical diagnosis. It can be effectively treated. Treatments are successful when you follow the protocol. The treatment can save lives; it can protect marriages, family, jobs and death. The treatment is not a one quick fix this is a disease which is going to continue to bother you so you have to treat it like it’s a chronic relapsing disease and it will take a long-term maintenance treatment plan to return back to your normal life. Medically assisted treatment is successful, highly effective in combination with the group counseling. We encourage everybody to look for a specialist who understands the treatment, follow the treatment and look at the new advances. Because the new advances is going to help the whole landscape of treating opioid addiction. Probuphine it’s a very important powerful new advance in treatment of Opioid Addiction. It will be useful tool for selective patients. Not for every patient is suitable candidate, but it’s going to be used for selective patients for whom it will help prevent relapses without having to take Bupronephrine pills every day.

 

END OF INTERVIEW

 

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

 

If you would like more information, please contact:

Sherry Feldberg

781-684-0770

braeburnpharma@publicisgroupe.net

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