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Giving Addicts a “Reset” Developers working on first digital therapy app for addiction

Study finds alcohol changes the brain from the very first drink

BMXlife gives opportunities to at-risk youth through BMX bikes PREVENTION ON WHEELS

No Woman No Cry The woman who doesn’t feel

REDEFINING RECOVERY One Day at a Time takes holistic approach to overcome addiction

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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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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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Redefining Recovery One Day at a Time takes a holistic approach to overcome addiction

Recovery can be a tricky word. For some it’s short- hand for overcoming chemical dependence, while others distinguish it from words like “abstinence” or “sobriety.”The word represents what an individ- ual does with a new life — how one uses past expe- riences to overcome hardship and thrive spiritually. One Day at a Time (ODAAT) recognizes that this distinction applies to populations beyond addicts and alcoholics, and aims to serve anyone in need of a fresh start. “When we say ‘recovery,’ we’re not just talking about drugs and alcohol,” says President Mel Wells. “We mean any challenges in life.”The support for addiction recovery is there, Wells says, but it rep- resents just one of ODAAT’s holistic services; they also address homelessness, HIV/ AIDS, poverty, and violence and gang prevention, to name a few. Historically speaking, ODAAT’s primary services give shelter and supportive housing to those in need. They have 60 beds for recovering addicts and alcoholics, a men’s and women’s house, each hold- ing 14 residents, and a 38-bed homeless shelter known as Safe Haven. The men’s and women’s homes work with clients to afford them low-cost, supportive housing; Safe Haven and the drug and alcohol facilities are state- and cityfunded, and do not charge rent.

“When we say ‘recovery,’ we’re not just talking about drugs and alcohol. We mean any challenges in life.” - Mel Wells president of One Day at a Time (ODAAT)

“In a lot of cases, the person who has been through those struggles is going to be more driven in life and more successful.” - Mel Wells president of One Day at a Time (ODAAT)

No one left behind Wells takes pride in ODAAT’s “no one turned away” ethos. He says instead of turning people away, the organization has always made room or given referrals to prospective cli- ents on the spot. ODAAT has reach spanning as far away as London and Cambodia, Wells says. In Philadel- phia, ODAAT reaches up to 56,000 people annually, a figure Wells hopes to increase to 70,000 in the coming years. The city of Philadelphia and state of Pennsylvania have picked up on ODAAT’s efficacy, Wells says, and approved increased funding, allowing ODAAT to reach more and more people every day. Not only does ODAAT welcome everyone, it does it fast. ODAAT has staff on hand at all hours to handle incoming clients who often have nowhere else to go. There’s a narrow time frame in which some- one is ready and willing to receive help, and Wells doesn’t want to miss it. “They might change their mind, or they might not even have the chance to. They might not make it another day,” Wells says, speaking to the fatality of life on the streets and in active addiction.

Learning from each other Clients at ODAAT benefit from its widespread acceptance, and Wells says they gain a rare opportunity to grow from others’ stories. With an open, empathetic ear, clients gain insight to struggles they might not know firsthand. For instance, Wells describes the scenario of a recovering addict getting to know an AIDS patient — the addict might have no idea what a person with AIDS goes through every day to stay well, and vice versa. A new perspective can change a client’s attitude toward recovery. And for someone to survive and prosper through any number of life’s challenges, Wells notes, there is no telling what they are capable of. “In a lot of cases, the person who has been through those struggles and comes out is going to be more driven in life and more successful,” he says.

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