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GIVING ADDICTS A RESET Developers working on first digital therapy app for addiction

IMPLANT REPRESENTS REVOLUTIONARY NEW APPROACH TO TREATING OPIOID ADDICTION MORE THAN SKIN DEEP

SCIENTISTS DISCOVER POSSIBLE “METH GENE” BORN WITH IT

COPING

GENERATIONAL BRAIN DAMAGE

DISCRIMINATION

Drinking during pregnancy presents parents with challenges beyond their own sobriety

WITH

DISCRIMINATION REMAINS LARGELY IGNORED AS A CAUSE OF SUBSTANCE ABUSE

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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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BORN WITH IT Scientists Discover Possible 'Meth Gene’

Researchers have recently identified a gene that may play a role in meth addiction. New findings by Boston University School of Medicine researchers, published in PLOS Genetics, spotlight a gene called heterogeneous nuclear ribonucleoprotein H1 (Hn- rnph1). The research uncovered a link between this gene and how it effects behavior when stimulants are introduced. This new insight can help scientists understand genetic risk factors for addiction, along with some neuropsychiatric disorders. Also, this new understanding about how Hnrnph1 works could lead to the development of a prescription drug to help treat meth ad- diction, researchers say.

Need To Ident i fy Targets

other findings to improve the treatment of both dopamine- related problems like attention- deficit hyperactivity disorder, schizophrenia, and bipolar disor- der, along with dopaminerelated neurodegenerative disorders like Parkinson’s or Huntington’s diseases. Scientists say the genetic epide- miology of meth use disorders is very complex. Efforts to under- stand the biological processes that increase susceptibility to meth use disorders (i.e., abuse, dependence and psychosis) have uncovered several genetic variants. However, more research needs to be done. Though gene research can led to breakthroughs in treatment, Boston University points out in its news release that genetics alone are not responsible for addiction. Environmental and social factors also play an im- portant role.

The BU scientists discovered that Hnrnph1 “codes” for an RNA protein that regulates how other genes are processed in the brain. To better understand the genetic basis of meth addiction, the next step is to figure out the exact genetic targets of Hnrnph1. “A better understanding of the brain region and cell type-specific binding targets of Hnrnph1 will tell us more about the function of this gene and possibly identify new therapeutic strategies for minimizing risk and treating psycho-stimulant addiction — a disorder for which there is currently no FDA-approved drug,” says study co-author Dr. Camron Bryant in a news release from Boston University.

The study could also lead to

Other factors in addict ion According to the National Institute on Drug Abuse (NIDA), these are some of the environmental factors that come into play with ad- diction: • Friends and people addicts spend time with • Age when a person begins using drugs or alcohol • Neighborhood

“A better understanding

of the brain region and

cell typespecific binding

targets of Hnrnph 1 will

tell us more about the

function of this gene.” — Dr. Camron Bryant, study co-author

• Availability of drugs and alcohol • Presence of mental health issues • Gender

These environmental influences interact with genetic factors to influ- ence an individual’s susceptibility to addiction. While scientists hope to better understand the role genetics plays in addiction to meth and other drugs, much more research needs to be done to solve the puzzle.

Genetics alone are not responsible for addiction. Environmental and social factors also play an important role.

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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.

Gateway Foundation Contact Us: 309.247.8440 gatewayfoundation.org 11 S. Capitol Street, Pekin, IL 61554

Discrimination, whether based on race, gender, or sexual orientation, has long been thought to be a contributor to substance abuse. Now a new study has confirmed the relationship between discrimination and addiction, but it’ s also brought up many more questions that still need to be answered in order to improve treatment outcomes. Researchers at the University of Iowa recently com - pleted a peer review study in which they looked at 97 previous studies on discrimination and alcohol use. Their goal was to summarize the collective knowl - edge researchers have uncovered throughout the years, and what they found confirmed in more detail what many had previously suspected.

“Generally there is good scientific support, but the evidence is mixed for different groups and for types of discrimination.” - Dr.Paul Gilbert, University of Iowa

overtly racist or sexist to another person. But less research has been done on what are known as mi - cro-aggressions, small everyday occurrences that can rub a person the wrong wa y. That research is improving, but there are other factors that need to be more fully explored. While studies have looked at historical trauma in the African-American popula - tion, the concept has not been fully investigated with regards to Hispanic and Asian populations. “This notion of historic trauma could be really rel - evant to other groups, but it hasn't received much attention at all,” D r. Gilbert says. “This is something we should pay attention to.” All of this adds up to the fact that treatment provid - ers may be missing a key piece of the substance abuse puzzle.

The team found that discrimination did indeed lead to an increase in drinking frequenc y , quantity of alcohol consumed, and in the risk for alcohol use disorders. Researchers say drinking can represent a coping mechanism in response to the stress caused by discrimination, and several studies showed clients acknowledging this direct link themselves. But when looking at specific populations and types of discrimi - nation, the picture becomes less clea r. “The story is that generally there is good scientif - ic support, but the evidence is mixed for different groups and for types of discrimination,” says D r. Paul Gilbert, the study’s lead author. “We don’t real- ly know comparing one type or one level to anothe r .” For example, much research has been done on inter - personal discrimination where someone is

But just because the intricacies of how discrimination affects drink - ing aren’t yet fully understood, that doesn’t mean our current knowledge base can’t be helpful. D r . Gilbert says simply knowing that experiences with discrimination can drive drinking could in - form the way treatment providers interact with clients, opening new areas of their lives to explore during treatment. “It can serve as sort of an early warning or indicato r ,” D r. Gilbert says. “For treatment providers, it ’ s worth looking at: is there some - thing that may be keeping folks from accessing services or affecting outcomes?”

Dr . Gilbert says treatment providers should continue to address discrimination as part of a holistic approach to recover y . He says it will be up to researchers to fill

in the gaps to find the precise ways that discrimination affects drinking behavio r. “W e’ve got good evidence on this level of interpersonal discrimination,” D r. Gilbert says. “W e’ve gotten the low-hanging fruit, now it’ s time to start working on the stuff that’ s a little further up the tree.”

“It can serve as sort of an early warning or indicator.” - Dr. Paul Gilbert, University of Iowa

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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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