Camelot

COMMUNITY CARE CAMELOT

Redefining RECOVERY

RESOURCE GUIDE

PROLONGING THE PAIN

F IRE WI TH FIGHTING F I R E

Giving Addicts

Researchers look to combat addiction withrough repurposed pharmaceuticals

A “Reset” Developers working on first

digital therapy app for 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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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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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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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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7162 Reading Rd. Suite 300, Cincinnati, OH 45237 513-961-5900 camelotcommunitycare.org

Change A Lifetime

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7162 Reading Rd. Suite 300 Cincinnati, OH 45237 513-961-5900 camelotcommunitycare.org