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CONGENITAL INSENSITIVITYTO PAIN

MORE THAN SKIN DEEP Implant Represents RevolutionaryApproach to Treating Opioid Addiction

Giving Addicts A “RESET” FIGHTING FIRE WITH FIRE Researchers look to combat addiction through reproposedpharmaceuticals

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Giving addicts a “reset ” Developers working on first digital therapy app for addiction One reason the opioid addiction epidemic has taken hold in many rural areas is that many Americans with substance use disorder live long distances from the nearest treatment providers. But a new tool may provide hope.The U.S Food and Drug Administration (FDA) is currently reviewing a new tool that may help remedy that geographical problem: the first prescription digital therapy designed to treat SUD. Boston and San Francisco-based Pear Therapeutics developed reSET, a mobile app used as a treatment tool concurrently with outpatient therapy centered on SUDs.The project has demonstrated better abstinence and treatment retention when applied alongside face-to-face therapy focused on SUD-related treatments for alcohol, marijuana, cocaine and stimulants.The therapy also includes a web-based program for healthcare providers. An app to help opiate addicts Pear is also developing reSET-0, an app specifically designed to help opiate addicts. Both apps consist of a patient-facing smartphone application and a clinician-facing web interface. The company raised $20 million last year with the aid of various venture companies including Arboretum Ventures, an Ann Arbor, Mich.-based venture capital firm. “(reSET) will give patients and clinicians a new tool to improve therapy specifically in an area right now that is a true health epidemic in the U.S,” Dr.Thomas Shehab, managing director at Arboretum Ventures, told DrugAddictionNow.com. “It’s an extremely novel approach to central nervous system and behavioral health diseases that we didn’t see anyone else addressing in that way.”

Pear submitted reSET for review by the FDA during the first half of 2016 and says it is expected to be approved this year. Dr. Shehab said his firm is “particularly intrigued by their approach because it’s a combination of a very well-studied digital therapy being used in conjunction with other therapies.” He says, “We thought the unique makeup of the Pear team and their unique approach to digital therapies really made us feel it had the highest likelihood of success in really helping address these issues.”

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According to data provided by Pear Therapeutics, 507 people with SUD from 10 treatment centers nationally received either face-to-face therapy or reduced volume of face-to-face therapy with reSET.They were given 12 weeks of outpatient therapy with or without using the app; if without, a portion of the digital therapy was replaced with face-to-face therapy. Abstinence was calculated two times weekly through a breathalyzer, urine samples and self-reports. Of the participants dependent on alcohol, marijuana, cocaine and stimulants, 58.1 percent of them receiving treatment with reSET were abstinent during weeks nine through 12, versus 29.8 percent of participants receiving only face-to-face therapy. Of the participants who started the study with a positive drug test, 26.7 percent of them who received reSET were abstinent during weeks nine through 12 of the study; only 3.2 percent of those that received traditional face-to-face therapy reported abstinence during the same time period. Participants using reSET presented statistically significant advancement in retention rates compared to those not using the app. After 12 weeks, 59 percent of participants that received face-to-face therapy retained sobriety in comparison to the 67 percent of those that used reSET.The reSET-O app has shown promising results in

three independent and randomized clinical trials, the company says. A study of 465 participants that completed outpatient methadone or buprenorphine treatment for opioid addiction was conducted, in which the participants were given standardized face-to-face therapy or shortened standardized treatment with reSET-O.Their abstinence was determined by self-reporting and urine tests. The developers plan to submit reSET-O to the FDA for approval, pending approval of reSET. “With all that’s going on, this is a very exciting company that we’re very enthusiastic about because it benefits a group of patients in great need,” Dr. Shehab said. “We think that reSET has a lot of potential.”

Maker receives NIDA grant In July, Pear announced it

has received a Small Business Innovation Research (SBIR) Fast-Track award funded by the National Institute on Drug Abuse (NIDA). PEAR will collaborate with CleanSlate Research and Education Foundation and Columbia University Medical Center Department of Psychiatry’s Division on Substance Use Disorders on the project. The grant will support the application of “enhanced engagement and gamification mechanisms” to reSET and reSET-O, the company says.

“It benefits a group of patients in great need.” - Dr.Thomas Shehab, Arboretum Ventures

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STUDY METHODOLOGY Studying mice genetically modified to be without the Nav1.7 channel, Wood found that such mice had bodies that dis- played a large increase in certain genes responsible for creating opioid peptides. Opioid peptides occur naturally in the body as the body’s painkiller and have a similar effect as opioids. In making more of the opioid pep- tides, the mice were blocking any feelings of pain, which might be the reason people suffering from CIP also don't feel pain. Wood thought that if he gave mice a medicine that reversed the effect of the opioid peptides, it may reverse the disorder. He gave the mice naloxone—a medication used to reverse opioid overdoses—and it worked. Wood figured the same could be done for humans. “After a decade of rather disap- pointing drug trials, we now have confirmation that Nav1.7 is a key element in human pain,” Woods says. “The secret ingredient turned out to be good old-fashioned opioid peptides, and we have now filed a patent for combining low dose opioids with Nav1.7 blockers. This should replicate the pain- lessness experienced by people with rare mutations, and we have already successfully tested this approach in unmodified mice.” CONGENITAL INSEN- SITIVITY TO PAIN (CIP) is a very rare genetic mu- tation that prevents mes- sages of physical pain from reaching the brain.

Research researcher and his team of researchers studied a 39-year-old woman with CIP. Using a laser beam and a dose of naloxone, Wood helped the woman, who elected to partici- pate anonymously, feel pain for the first time in her life. “Used in combination with Nav1.7 blockers, the dose of opioid needed to prevent pain is very low,” says Wood in an UCL release. “People

Using a test subject with a ge- netic mutation that prevents her from feeling pain, scientists have conducted research that shows promise in creating more effec- tive painkillers—and potentially decreasing the need for addictive opioids. Congenital insensitivity to pain (CIP) is a very rare genetic muta- tion that prevents messages of physical pain from reaching the brain. Sufferers of the disorder, as babies, will chew their lips until they bleed. Toddlers have to deal with more potential for falls, bumps and being hurt by hot or sharp things. Adults are at a high- er risk of dying prematurely. The disorder leaves those afflict- ed without channels known as Nav1.7, which carry sodium to sensory nerves. Understanding this disorder and channels of pain reception and delivery has led re- searchers to study the disorder for ways to block pain in those who don't have the disorder. Research- ers thought they could block pain transporting channels in people without CIP so they can help those with chronic and painful ailments like arthritis. HELPING A WOMAN CRY In a study published by the journal Nature, John Wood, a University College London (UCL) Wolfson Institute for Biomedical

with nonfunctioning Nav1.7 produce low levels of opioids throughout their lives without de- veloping tolerance or experiencing unpleasant side effects.”

As for this work leading to com- plete cessation of pain, Wood tells the New Scientist that some research has found success, but nothing has led to the complete pain loss found in those that are naturally without Nav1.7 channels.

who doesn’t feel the Woman WHAT THE FUTURE HOLDS.... As for people with CIP, Woods says he doesn't know if treatment using nalox- one is an option. Long-term use of naloxone could have side effects. What Woods can say, definitively, is that the mice in the experiment felt as little pain as mice who did not have the Nav1.7 channel naturally. Woods, his team, and the rest of the field are working to fill in the re- search gaps to start answering these questions for humans. “We hope to see our approach tested in human trials by 2017 and we can then start looking into drug combinations to help the millions of chronic pain patients around the world,” Woods says. Imperial College London professor Kenji Okuse reacted to Wood’s findings to the New Scientist, saying that the research will provide more information to doc- tors about pain.

Could help in making better painkillers.

We hope to see our

“Opioids and Nav1.7 blockers could provide much stronger analgesics, but they will not necessarily be better for patients,” Okuse says. “If we take the combination therapy route, people would have to take opioids throughout the lifetime, which is not a welcome thing.”

approach tested in human trials by 2017 and we can then start looking

into drug combinations to help the millions of chronic pain patients around the world. — John Wood, University College London Wolfson Institute for Biomedical Research researcher

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FIGHTING FIRE WITH FIRE

“I think this opens up a large world view with regards to this system in the brain.” - Dr. Heath Schmidt

“These results are very provocative and suggest these compounds could be repur- posed for drug addiction.” - Dr. Heath Schmidt,

University of Pennsylvania

D espite years of stigma, medication-assisted treatment (MAT) is steadily gaining in popularity among treatment providers. Government groups like the U.S. Department of Health and Human Services are actively campaigning to get more providers to offer MAT as a potentially vital resource for patients. While such groups often promote well-known medications such as methadone and buprenorphine, drug researchers are looking for new medications that could be a lifeline to patients in need. But new medications can cost millions to research and take years to get on the market. That’s why some researchers are taking a closer look, and finding success, with drugs already approved by the FDA. CURBING COCAINE USE Researchers at the University of Pennsylvania say a drug already on the market for diabetes may be able to curb cocaine use. The FDA-approved drug Byetta, used to regulate blood sugar in diabetic patients, is derived from a natural hormone known as GLP-1. The research team looked at how the hormone functioned in rats and found that the same hormone that regulates food intake could be used to suppress cocaine consump- tion. “These results are very provocative and suggest these compounds could be repurposed for drug addiction,” says Dr. Heath Schmidt, one of the lead researchers. “We have seen a reduction in cocaine consumption…but it doesn’t completely abolish it.” Currently, there is no FDA-approved drug for the treatment of cocaine abuse. But because Byetta and a similar drug have already gained federal approval, researchers say that leaves fewer hurdles before they could be used in treatment settings. Although still far from human trials, research- ers say they’re optimistic, especially because their research suggests the hormone is not specific to cocaine and could be used in treatment of other substance abuse disorders. “I think this opens up a large world view with regards to this system in the brain,” Dr. Schmidt says. “There’s really a lot to be explored here and I think it’s really an exciting time to be in the field and exploring the GLP- 1 system.”

ADJUSTING ALCOHOL CONSUMPTION Another team of researchers at the University of Queensland in Australia believe the FDA-approved drug pindolol could be used to stop alcohol abuse. Pindolol is an anti-hypertensive medication used to treat high blood pres- sure. But because of the way it interacts with neurotransmit- ters in the brain, they believe it could also be effective in treating alcohol use disorders (AUDs). To study the drug’s effect, the team used mice and exposed them to an alcohol consump- tion regimen similar to a binge drinking cycle common in humans. For mice also given pindolol, the team found they were able to reduce drinking in the long term (after at least 12 weeks). The team did not see as positive of results in the short term (only four weeks), but they say they’re still excited about its potential uses. “Although further mechanistic investigations are required, this study demonstrates the poten- tial of pindolol as a new treat- ment option for AUDs that can be fast-tracked into human clin- ical studies,” the authors wrote.

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More Than Skin Deep Implant represents revolutionary approach to treating opioid addiction

M edication-assisted treatment is growing in popularity and acceptance among addiction recovery professionals. And now it’s taken a revolutionary step forward that could offer renewed hope to thousands of people struggling with an addiction to opioids. The U.S. Food and Drug Administration approved a new buprenorphine implant to treat opioid depen- dence. Buprenorphine had previously been available only as a pill or a dissolvable film placed under the tongue. But the new implant, known as Probuphine, can administer a six-month dose of the drug to keep those dependent on opioids from using by reducing cravings and withdrawal symptoms. "Opioid abuse and addiction have taken a devastating toll on American families,” FDA Commissioner Dr. Robert M. Califf said in a statement. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives.” The implant comes in the form of four one-inch rods that are placed under the skin on the upper arm. The implant must be administered surgically and comes with the possibility of certain side effects, but experts say it could be more convenient and more effective for patients. They say by eliminating the need to take pills, fill prescriptions and generally manage their medication, it makes it easier for people to focus on the other areas of their recovery while making it less likely someone will lapse in their treatment plan.

Sign of the Times Experts say the newly approved implant also provides a big boost to the concept of medication-assisted treat- ment (MAT) in general. For years, the idea that someone could achieve recovery through the use of drugs like methadone and buprenorphine was rejected by many professionals in the field who saw complete abstinence as the only true sobriety. Many still hold that belief, but attitudes appear to be changing. Top government officials say they want to increase the amount of MAT taking place at the country’s treatment centers. Several states as well as the federal government have enacted laws making it easier for physicians to pre- scribe medications like buprenorphine, but they say too few patients receive the medication they need. “Scientific evidence suggests that maintenance treat- ment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, in a statement. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.” ] [ "Opioid abuse and addiction have tak- en a devastating toll on American families.” - Dr. Robert M. Califf, FDA Commissioner

“We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives.” - Dr. Robert M. Califf

Although the implant is certainly a new alternative, it has yet to show any increased success in keeping people from relapsing compared to the pill or film tablet. In a study of the implant’s effectiveness, they found that 63 percent of people given the implant were free of illicit drugs at six months, compared to 64 percent of people who took buprenorphine by pill. Still, those rates are much higher than the success rates of people who follow abstinence-only treatment plans. And officials hope the new implant will lead more people to get MAT, increasing the number of successful recoveries across the country.

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INSERT 6 Learning to Drink

Study finds alcohol changes the brain from the very first drink

“ Drugs of abuse basically hijack the normal learning and memory processes. ” - Dr. Dorit Ron University of California - San Francisco

Preventing escalation

The NIAAA-funded study did not establish a relationship between initial use and addiction, or even problematic drinking. But the hope is that further understanding of how alcohol affects the brain initially could lead to better treatment and prevention efforts down the road. “If we can control that step, we may be able to prevent further escalation,” Dr. Ron says. More research is needed to determine which other components of the brain are affected by initial alcohol exposure. Dr. Ron says she believes the changes that occur during first exposure could be reversed with prolonged abstinence from alcohol. But she said the more a person drinks, the harder it is to reverse those changes as the brain forms stronger connections to drinking.

One drink is all it takes. That’s what one research team found when studying how even the first exposure to alcohol can affect a person’s brain. A team from the University of California - San Francisco exposed mice to alcohol and then studied the synapses (connections) in their brains.The team found that even the first drink produced significant changes in the brain’s biological structure, calling the changes a “learning event.” “This is basically the first step,” says Dr. Dorit Ron, one of the chief researchers. “You are basically placing a memory trace.” Dr. Ron says the entire study was based on the idea that “addiction, and not just alcohol addiction, is thought to be a maladaptive form of learning and memory.” In essence, the study showed that first exposure to alcohol primes the brain for further use and lays the foundation for future “learning.” “Drugs of abuse basically hijack the normal learning and memory processes,” Dr. Ron says. “The behavior becomes habit.”

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Predicting behavior

INSERT 6 A new study also suggests that the earlier a person starts drinking, the stronger those connections may become. Researchers recently set out to identify which substance people use first in their lives and found the majority of people try alcohol before any other substance.The team also looked at how a person’s age when they start drinking affects substance use later in life. Researchers say the earlier someone starts drinking, the more likely they are to use more than one illicit substance, and they’re also more likely to develop an addiction. “It’s a very nice predictor for polysubstance use,” says Dr. Adam Barry, the study’s chief author. “The later you delay, the closer you are to 21, the less likely you are to be alcohol dependent or dependent on other substances.”

“ Alcohol consumption among youth doesn’t occur in a vacuum. ” - Dr. Adam Barry, Texas A&M University

Curbing use Researchers acknowledge there’s a difference between a first sip and a first binge drinking event. But they say age at first use of any kind is still a good predictor of behavior later in life. To combat problematic drinking, Dr. Barry says educators need to address all factors of a child’s life, not just the substance itself. In keeping with new guidelines from the National Institute on Drug Abuse, Dr. Barry and his team recommend beginning substance education as early as third grade. “Alcohol consumption among youth doesn’t occur in a vacuum,” Dr. Barry says. “It’s really just trying to find evidence-based strategies that prevent drug use and then applying those in an alcohol setting.”

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