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BORN WITH IT Sciencetist Discover Possible “METH” Gene RELASPE TRACKERS GIVING ADDICTS A “RESET” Developers working on first digital therapy app for addiction TO END THE OPIATE EPIDMIC “Fitness trackers could help prevent relapses”

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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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0 END THE

"Not only are the recommendations comprehensive they were developed with input from a wide range of stake- holders, and wherever possible draw from evidence-based research:'

SENSEOF URGENCY

“This is a complex epidemic with no simple solutions.” —Dr. G. Caleb Alexander, co-director of the Johns Hop- kins Center for Drug Safety and

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“There’s a lot of information that can be gained from when somebody relapses.” - Dr. Stephanie Carreiro, University of Massachusetts

Fitness trackers could help prevent relapses

Dr. Carreiro says wearable biosensors can detect a relapse event for some substances (like heroin and cocaine) by sensing a change in heart rate or other physical conditions. The treatment provider can then use the fitness tracker ’s other information, like the time and location of the relapse event, to develop a profile about the conditions that prompt a patient to use. “It gives us very specific contextual information and serves as that reminder to the patient that someone could potentially know right away when they relapse,” Dr. Carreiro says.

Fitness trackers, or wearable biosensors, like Fitbit and Jawbone are the latest fitness trend to gain widespread popularity. But some believe they could be used to treat addiction as well. New research suggests the devices can be used to reliably detect relapses, which could then give treatment providers the information they need to prevent relapses in the future. “There’ s a lot of information that can be gained from when somebody relapses,” says Dr. Stephanie Carreiro, a researcher from the University of Massachusetts.

ACCOUNTABILITY MATTERS That accountability to someone who could see the relapse is an important step in moving past simple self-reporting and drug testing. People can lie during self-reports and drug testing will only show that drugs were used, but not information like how much was used, when it was used, and where. Because the sensors can be easily removed, the system will only work for patients who are truly motivat- ed to stay sober. Dr . Carreiro says rather than a big brother scenario with treatment providers tracking a patient’s movements, the devices simply connect a patient to their support network. “We could potentially trigger an interaction with a patient just seeing if they’re okay and need some help,” Dr. Carreiro says.

“It definitely served as a reminder that there was something motivating them to stay sober.”

- Dr. Stephanie Carreiro

SIMPLE REMINDER In a study of 15 patients, nearly everyone kept wearing the devices even when relapsing. D r. Car- reiro says that’s because many people are already used to wearing fitness trackers, and the treatment plan simply fits into the daily routines they’ve al - ready established. Researchers also say just having a physical object on a patient ’s wrist to remind them about their dedication to sobriety can be enough to prevent a relapse. “Multiple people looked at it and thought of going back to jail or being there for their children,” D r. Carreiro says. “It definitely served as a reminder that there was something motivating them to stay sobe r.”

WHAT ABOUT PREVENTION? The ultimate goal is to prevent relapses and keep patients on the path to sobriety. While the tech- nology is advancing quickl y, researchers say the collective knowledge base simply isn ’t there yet to predict a relapse event. But as they conduct more studies and develop better algorithms with the information gained, they should be able to tailor interventions to a specific patient and hopefully keep them from relapsing. “We need to continue to define different pro - files so that we can get a more complete under - standing of what ’ s happening,” D r. Carreiro says. “That’s when it will be the most powerful.”

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Prevention On Wheels BMXlife gives opportunities to at-risk youth through BMX bikes “I see the bikes as a means to get through to kids about other initiatives.” - David “Joby” Suender outreach coordinator and assistant to the president at ODAAT

BMXlife is a One Day at a Time (ODAAT) youth initiative that launches this summer to get kids on the streets - in a positive way. In its inaugural season, kids will learn pedestrian and bike safety, as well as the “rules of the road,” says David “Joby” Suender of ODAAT, who started the initiative. Many participants do not have access to bikes at home, so it could be their first time putting foot to pedal on one of 10 new bikes the program provides.

Beyond the riding, Suender hopes to convey bigger messages of pre- vention. “I see the bikes as a means to get through to kids about other initiatives - violence, drugs, healthy living,” he says.

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Philly freestylin’ Once they learn the basics, their sur- roundings provide ample room to progress. Suender says Philadelphia is particularly well-suited for BMX riding in particular, a form that can involve performing tricks on manmade features in the cityscape. “It’s great because of the environment that’s readily available to these kids,” Su- ender says. He goes on to describe the city’s features, historic and contemporary, that provide a wealth of obstacles for BMXers to tack- le. The city has been featured numerous times in skateboard and BMX videos, and a rider need not travel far to find a handrail to grind down, or a concrete ledge to jump off.

Two wheels, endless opportunities For those less inclined to the thrill of street riding, BMXlife covers many alternative aspects of riding. Suender says there are other valuable opportunities that biking can offer. He says having a hobby like biking can keep kids motivated and focused on something other than gangs and street life. The physical activity promotes healthy living, and the bike itself can serve as a sustainable means of transportation. Taking a look at the broader BMX industry, Suender says he will educate kids on filming, editing, photography and the mechanics of bike repair. “Maybe one of the kids won’t be into the riding aspect, but they’ll be into the mechanical side, or the filming and editing,” Suender says. “This will set them up with interests they can pursue down the road.” They are all skills Suender has successfully employed in his own BMX career. He says that BMX riding has enabled him to travel domestically and abroad, with his riding featured in videos, maga- zines and websites. It lends credibility to his message for the kids he works with, that they can do whatever they put their mind to. No matter which direction BMXlife leads its participants, the BMX culture presents opportunities that might not reach the kids through other media. And at the very least, Suender’s leadership sets an example for kids at risk. “I’m trying to provide a male role model and mentorship,” he says, “because a lot of these kids are coming from broken homes and don’t have any other outlets.” “Maybe one of the kids won’t be into the riding aspect, but they’ll be into the mechanical side, or the filming and editing. This will set them up with interests they can pursue down the road.” - David “Joby” Suender

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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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Everybody Deserves A Chance

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