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ANTI SMOKE Fresh Empire’s anti-tobacco appeal is all about staying independent SIGNALS PREVENTION ONWHEELS BMXlife gives opportunities to at-risk youth through BMX bikes Giving Addicts a “Reset” Developers working on first digital therapy app for addiction

PROLONGING THE PAIN Study suggests painkillers may be having opposite effect in the long run

Brain Damage Generational Drinking during pregnancy presents parents with challenges beyond their own sobriety

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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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When you are addicted to tobacco, you are not in control. So says the main message of Fresh Empire, an Internet and TV campaign designed to inspire teens and young adults to stay away from cigarettes. Fresh Empire’s website—freshempire.betobaccofree.hhs.gov—has infor- mation and informational videos all about the consequences of smoking. Here, young people can learn about the chemical content of cigarettes, health risks associated with tobacco use and social drawbacks. Fresh Empire, sponsored by the U.S. Food and Drug Administration and U.S. Department of Health and Human Services (HHS), puts on events with performers such as rappers Silento and Stuey Roc, who deliver posi- tive, tobacco-free messages. “Being fresh is about yourself. The empire is yourself, man,” says radio per- sonality ET in video footage of a Fresh Empire concert. And Rock had this to say about tobacco use on a Fresh Empire video: “Smoking is not cool.” a nti-smoke Signals “Being fresh is about yourself. The empire is yourself, man.” - Radio personality ET Fresh Empire’s anti-tobacco appeal is all about staying independent

Tobacco statistics “What’s the deal with tobacco?” asks a Fresh Empire graphic. With this ques- tion, it launches into the ingredi- ents found in cigarettes, along with the health and social side effects of smoking. Images on Fresh Em- pire’s website show freshfaced youth looking directly into the camera as a way to deliver a straightforward and relatable source of information for young people. Fresh Empire does not rely on imag- ery alone. It also provides poignant statistics and cites research conduct- ed by the HHS and Internal Agency for Research on Cancer, among other organizations: •Cigarette smoking causes 480,000 deaths per year. • Smokers die, on average, 10 years younger than non-smokers. • 16 million people have at least one disease caused by smoking. A graphic on the site shows what Fresh Empire calls “all sorts of nasty chemicals” in tobacco, along with unsavory facts about those substanc- es. Listed first is carbon monoxide, which is found in car exhaust. Cig- arettes contain arsenic, Fresh Em- pire informs readers, which is used in pesticides. And there’s benzene, found in gasoline. Another header states simply “keep your cash,” which leads to a statistic that smoking half a pack a day costs an average of $1,000 per year. “That’s a lot of cash to blow on cig- arettes,” Fresh Empire states. “What would you rather spend $1,000 on?”

Online videos and TV ads The website has a series of short videos and TV ads, all with poignant soundbites and stories about the self-empowerment that comes from staying away from smoking. In a 30-second TV spot, young people, one after another, repeat the mantra, “I reject anything—including tobacco—that tries to control me.” Jayy Starr, a young hip-hop musi- cian, stars in a commercial where she tells the story of her grandfather. He smoked cigarettes for many years and died of lung cancer. “Losing my grandfather has influ- enced my whole musical being, because it makes me more passionate,” Starr says in a behind- the-scenes video for the ad. “I’m not going to lose

young man in sunglasses and a scarf. Throughout the videos, television ads and web content, Fresh Empire implores young people to think of cigarettes as an affront to autonomy. Surrendering to nicotine is not being in control, they say. Therefore, smoking is not fresh. “Losing my grandfather has influenced my whole musical being, because it makes me more passionate. I’m not going to lose another person to cigarettes. To me, being a leader means being

In another video, young people stand in the middle of the frame as messages flash on the screen alongside then. One reads “Long live Fresh Empire. Long live you. Live tobacco-free.” Another spot flashes empowering words for young women—“fresh,” “strong,” “boss,” “royal,” and “queen”—before a female voice-over says, “Fresh Empire is flippin’ the script in fash- ion, in hip-hop, in life.” Another video opens with the question “What’s Fresh Empire?” followed by a group of young people defining the tobacco-free movement. “It means looking out for you,” the first young man says. Another adds, “And your fam, too.” “When you are doing you, looking fresh, people follow,” says a stylish

tobacco-free.” -Singer Jayy Starr

another person to cigarettes. To me, being a leader means being tobacco free.”

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ain relievers are supposed to relieve pain. It sounds simple enough, but new research suggests a common pain medication may actually be prolonging chronic pain. P Prolonging the Study suggests painkillers may be having the opposite effect in the long run Pain

“We were surprised that morphine was able to induce these really long-lasting changes,” says Dr. Peter Grace, the study’s lead author. Dr. Grace says the cause of the chronic pain in- crease has to do with cells that form part of the immune system. He says if those areas could be isolated or their effects reduced, the resulting pain may not be as great. “If it does turn out to be a relevant issue to patients, then what our study suggests is that targeting the immune system may be the key to avoiding these kinds of effects,” Dr. Grace says. “Opioids could essentially work better if we could shut down the immune system in the spinal cord.” The team’s research only looked at spinal cord injuries and morphine, and did not study other opioids that are commonly prescribed to pa- tients experiencing pain. But he said it’s likely drugs like Vicodin or OxyContin could affect other parts of the body in a similar way. “While we haven't actually tested other opioids in this particular paradigm, we predict that we would see similar effects,” Dr. Grace says.

Morphine is an opioid painkiller commonly prescribed in hospitals and clinics, and while it is effective in the short term, doctors don’t always consider the potential consequences for pain down the road. That’s why a team of researchers based out of the University of Col- orado - Boulder set out to study how morphine treatment affects chronic pain, and found some troubling results. The team, which used mice with spinal cord injuries, found that in mice not given morphine, their pain thresholds went back to normal about four to five weeks after the injury. But mice who were given morphine didn’t see their pain levels return to normal until around 10 to 11 weeks, meaning the use of morphine effectively dou- bled the length of their chronic pain.

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Chronic problem Chronic pain can be debilitating for many people facing serious health problems, and it can also be a key factor in substance abuse. Many people report developing a dependence on opioids after having them prescribed for an injury. But new research suggests the number of people who develop dependency issues because of chronic pain may be far higher than people realize. A study from researchers at Boston Univer- sity looked at a group of nearly 600 people who had either used illicit substances or misused prescription drugs.

They found that 87 percent reported suffering from chronic pain, with 50 percent of those people rating their pain as severe. They also found that 51 percent of people who had used illicit drugs like marijuana, cocaine and heroin had done so to treat their pain. While many prevention ef- forts focus on recreational users, the numbers suggest that chronic pain plays just as prominent a role in substance abuse. “Many patients using illicit drugs, misusing prescription drugs and using alcohol reported doing so in order to self-medicate their pain,” the authors of the study wrote. “Pain needs to be addressed when patients are counseled about their substance use.”

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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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Drinking during pregnancy presents parents with challenges beyond their own sobriety

Since its first diagnosis in 1973, Fetal Alcohol Spectrum Disorders (FASD) have shown how devastating drinking during pregnancy can be for an unborn child. Despite this fact, at least one in 10 pregnant women drink in the U.S. every year, according to a recent study by the Centers for Disease Control and Prevention. The CDC says children with FASD have physical issues like low birth weight and growth, problems with organ systems and damage to parts of the brain.These issues lead to behavioral and intellectual disabilities, hyperactivity, difficulty with attention, and poor communication, reasoning and judgment skills. The incurable situation can produce lifelong issues with school and social problems, mental health and substance abuse issues, difficulty keeping a job, living independently and having trouble with the law. In 2010, drinking while pregnant cost the U.S. $5.5 billion, says the CDC.

“ In 2010, drinking while pregnant cost the U.S. $5.5 billion. ” — Centers for Disease Control

“ I don’t know how I’m going to tell her. It was something I could have prevented. ” —mother of an FASD infant

Dysfunction in the family tree FASD can be multi-generational. Besides the common familial curse of addiction, the disability itself can contribute to bad impulse decisions, making it more likely for one to drink in the present moment and ignore the possible consequences. For that reason, a mother who has FASD herself may not recognize the symptoms of FASD in her child, because she views her own symptoms as normal. A mother in Tucson, Ariz., who was in recovery before realizing her drinking had caused FASD in her child, says the guilt was tremendous. Having to explain to her daughter why she had FASD was going to be the hardest thing she had ever done. “I don’t know how I’m going to tell her. It was something I could have prevented,” she says. Early diagnosis is key Diagnosing fetal alcohol syndrome can be difficult. A simple blood test will not suffice. Doctors typically look for abnormal facial features, such as a smooth fulcrum (the ridge most of us have between our nose and lips), lower than average height and weight, a small head and the birthmother’s admission of alcohol use during pregnancy. There are many treatment options, including medication for certain symptoms, behavioral therapies, education and training for parents. It is most helpful for children to be diagnosed before the age of six, be in a nurturing family environment and have access to special education and social services. Having FASD is not a hopeless situation. Implementing treatment strategies at a young age can help a child thrive despite the disorder.

 Regardless, it is never too late to quit drinking. Since brain growth takes place throughout a woman’s pregnancy, the sooner a woman quits drinking, the better off her baby will be. Prevention is best To prevent FASD, the best scenario is for a woman to refrain from drinking any amount of alcohol during pregnancy. Ideally, women should quit drinking the moment they go off birth control. “About half of all pregnancies in the United States are unplanned, and even if planned, most women won’t know they are pregnant for the first month or so, when they might still be drinking,” says Anne Schuchat, principal deputy director at the CDC.

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