specializing in addiction recovery
14506 University Point Place Tampa, FL, 33613
Services We Offer: We offer clinical trials that cover
Dr. Mary Stedman, M.D. has been successfully completing clinical research studies in the Tampa Bay area since 1997. Taking her clinical research experience and combining it with her extensive pharmaceutical knowledge, she has developed one of the region’s most respected clinical research sites. Currently, she serves as the medical director and principal investigator of Stedman Clinical Trials while continuing to maintain an independent private practice.
a wide range of cases: • Alzheimer’s Disease • Depression • Schizophrenia • Osteoarthritis • Adult ADHD • Bipolar Disorder • Memory Loss • Memory Screenings • Depression Screenings
Education: BA, Pharmacy- University of Florida, Gainesville MD- University of South Florida, Tampa Residency: Psychiatry and Child Psychiatry, University of South Florida, Tampa What Are Clinical Trials Clinical trials are research studies on new drugs or new treatments sponsored by government institutions or pharmaceutical companies. These new drugs and treatments are the latest advances in medicine, but have not yet been approved by the FDA to market. They may have been prescribed for the treatment of one diagnosis and are now being studied for another diagnosis. Our staff will closely monitor each participant with medical evaluations throughout the entire trial and there is never a charge for these services, as the cost is paid by the sponsor of the trial. Our team has been conducting clinical studies in the Tampa Bay area for fifteen years. Our core values of honesty, integrity, and the search for empirical knowledge drive everything we do. We look forward to serving you.
Here at Stedman Clinical Trials, one of the most common diseases that we deal with in our patient population is Alzheimer’s Disease
ONE OPIOID OVERDOSE IS TOO MANY.
Florida 33613 | Visit stedmanclinicaltrials.com
Call 813.971.8311 | 14506 University Point Place Tampa,
“ Health care providers should have a one-on-one discussion with teens who indicate any substance use to assess level of risk, provide brief advice, and, if necessary, recommend further assessment for a treatment intervention. “
Talkin’ ‘Bout My Generation
NIDA Researchers Develop Screening Tool for Teen Substance Use This article is a condensed version of a piece that originally appeared on the National Institute on Drug Abuse (NIDA) website.
-Dr. Sharon Kelly, Friends Research Institute
Analysis of the data showed that almost all teens who reported on the BSTAD that they had consumed an alcoholic beverage on two or more days during the past year had an AUD. Conversely, teens who reported drinking on fewer than two days were unlikely to have this disorder.The corresponding BSTAD cut point for an NUD was nicotine use on two or more days during the past year and for a CUD was marijuana use on two or more days. BSTAD enables early detection Using these cut points, the researchers found that the BSTAD was highly sensitive. Ninety-six percent of teens with an AUD, 95 percent with an NUD, and 80 percent with a CUD would be flagged as likely in need of further assessment for a brief intervention or referral to treatment. BSTAD’s specificity was also high: 85 percent of teens without an AUD, 97 percent without an NUD, and 93 percent without a CUD reported use below the cut points, and so would be correctly classified. “Very low substance use frequencies were found to be optimal in identifying these disorders,” Dr. Kelly comments. The BSTAD does not distinguish
Researchers encourage regular screening Both the World Health Organization and the American Academy of Pediatrics recommend screening all adolescent patients for substance use since problems later in life often originate in adolescence. Still, many providers do not regularly screen their patients for substance abuse. “Providers are extremely busy and need a quick and valid screening measure for identifying teens who use substances,” says Dr. Kelly. She and colleagues developed the BSTAD in response to a NIDA call for new tools to fill this need. To create the BSTAD, Dr. Kelly and colleagues added the questions about tobacco and marijuana to the widely disseminated National Institute on Alcohol Abuse and Alcoholism screen for youth alcohol use. In the validation study, the FRI research team administered the BSTAD in person to half of the participants, and the rest of the participants self-administered the instrument on an iPad. The teens reported a strong preference for the iPad. The iPad version offers the potential extra convenience that results can be automatically transferred into a teen’s electronic medical record.
Teens’ use of addictive substances often goes undetected by health care providers. But NIDA-supported researchers have developed a Brief Screener for Tobacco, Alcohol and other Drugs (BSTAD), to help spot teens’ problematic habits. In a recent study, BSTAD developers Dr. Sharon Kelly and colleagues at the Friends Research Institute in Baltimore examined the frequencies of use likely to qualify a teen for a diagnosis of an alcohol use disorder (AUD), nicotine use disorder (NUD), or cannabis use disorder (CUD). The frequencies proved to be surprisingly low, according to the researchers.
the severities of the disorders, she notes, so when it flags a teen, providers need to follow up with questions to determine appropriate interventions or referrals to treatment. Furthermore, Dr. Kelly says, “Health care providers should have a one-on-one discussion with teens who indicate any substance use to assess level of risk, provide brief advice, and, if necessary, recommend further assessment for a treatment intervention.” Providers also should rescreen teens regularly, because onset of substance use can occur abruptly during adolescence. Pediatrics recommend screening all adolescent patients for substance use since problems later in life often originate in adolescence. Both the World Health Organization and the American Academy of
Teen drug substance use revealed For the study, the BSTAD survey employed a few, simple questions about teens’ use of alcohol, tobacco or drugs within the past year.The teens’ BSTAD responses revealed that 22 percent had used alcohol in the past year, 16 percent had used marijuana, 10 percent had used tobacco, and 3 percent had used at least one illicit substance other
than marijuana. (Original article by Eric Sarlin, M.Ed., M.A., NIDA Notes Contributing Writer) 28
ONE DAY DAY ONE OR YOU DECIDE.
Our dedicated research center is staffed by a team of full-time clinical research coordinators and clinical trial recruiters. All of our team members personally attend to patients with the utmost professionalism and each clinical trial is conducted according to FDA and ICH guidelines. Our accomplished staff place research integrity, patient safety and care as their top priorities.
14506 University Point Place • Tampa, FL 33613 | PH: (813)971-8311 | www.stedmanclinicaltrials.com
Data indicate that OUD-treating medications are both cost effective and cost beneficial
SAMHSA PUBLISHES BEST PRACTICES ON MEDICATION-ASSISTED TREATMENT FOR OPIOID USE DISORDER Best Practices
The Substance Abuse and Mental Health Services Administration has published new guidance to help health care professionals better understand medications that can be used to treat Americans with opioid use disorder (OUD). Treatment Improvement Protocol (TIP) 63, “Medications for Opioid Use Disorder,” reviews the use of methadone, naltrexone, and buprenorphine, the three FDA-approved medications to treat opioid use disorders. TIP 63 provides guidance for health care professionals and addiction treatment providers on how to appropriately prescribe these medications and effectively support patients using these medications for OUD treatment. “We know that people can and do recover from opioid use disorders when they receive appropriate treatment, and medication-assisted treatment’s success in treating opioid use disorders is well documented,” said Dr. Elinore F. McCance-Katz, assistant secretary for Mental Health and Substance Use. “TIP 63 emphasizes that increasing access to medications to treat opioid use disorder will help more people recover, enabling them to improve their health, living full and productive lives.” TIP 63 is part of SAMHSA’s larger response to the opioid crisis. More access to treatment with OUD medications is critical to closing the gap between treatment need and treatment availability and an important public health strategy. Data indicate that OUD-treating medications are both cost effective and cost beneficial.
Treatment Improvement Protocol 63, “Medications for Opioid Use Disorder,”
reviews the use of methadone, naltrexone, and
buprenorphine, the three FDA-approved medications to treat opioid use disorders.
TO CURB OPIOID ADDICTION NEW MONTH, NEW RESOLVE Empowering homeless families and individuals to improve self sufficiency, self advocacy, and holistic recovery.
Not the solution, but maybe a good step forward Suboxone is not the solution, but in many cases it’s better than nothing, and a good response for chronic relapsers who are risking death from overdose. At least the addict is getting some exposure to treatment which is more likely to lead to recovery in the long run. Suboxone buys people time and keeps them alive. There are quite a few people who’s funerals I’ve attended that I wish had gotten on Suboxone. You can’t treat the dead.
The Subs knock down the monster cravings almost completely, and people don’t go through the nasty withdrawal that’s so painful. Once dysfunctional people who couldn’t hold a job, or were constantly on the obsessive hunt for the next fix suddenly become much more functional, and the addiction looks like it’s in remission. They can work consistently, they stop chasing the drugs, they have more money and can care for themselves and their families, and their addiction doesn’t seem to be ruling their lives. It seems like magic! Very few people actually wean off Suboxone successfully Suboxone users often wrongly think they’re cured because they look and feel more functional. Then they think all they have to do now is wean down, or taper off the medication, which is what the clinic doctors help them manage over a number of months to years. The problem is they’ve done nothing about the underlying addiction and all the addictive thinking and coping that go along with it that drive the addiction from within. They haven’t developed any social support, or learned anything about themselves and their disease. We like to say that using, or putting some chemical into the body, is only a symptom of the underlying disease. Abusing substances is not the actual disease—just a symptom. As soon as they stop using the Subs the addiction is still there and ready to start expressing itself all over again through the many painful ways it does. Chemically addicted people cope with life stressors with chemicals—that is, unless they make some fairly significant changes. Suboxone changes nothing in the end. Suboxone changes nothing A combination of Suboxone treatment coupled with AA/NA (with Sponsor and Step work) is a great thing. At Crossroads Counseling we require anyone with a substance abuse issue
Dead people don’t get into recovery
D. Waters Is Suboxone a Reasonable Treatment Option for Opioid Addicts? After twenty years of providing substance abuse treatment I can tell you that the ultimate goal of anyone battling an addiction is total abstinence. Every addict and alcoholic eventually figures out they can not control their usage, and moderation is unrealistic. Learning to live life on life’s terms is part of the process of learning to live abstinent. Self-help programs like Alcoholics Anonymous(AA) and Narcotics Anonymous(NA) do a great job of helping people understand their addiction, themselves, and effective solutions for coping with their disease. Dead people don’t get into recovery Opioid addicts are not terribly different from any other addict or alcoholic, except the risk of death by accidental overdose is huge. People are dying in droves from opioid overdose. The current heroin epidemic is even more dangerous than the pain killer epidemic it replaced. Relapse rates are tremendous. Unfortunately, it may take years before an individual addict is ready to give the 12-Step AA/NA
I’ve truly never seen anything work better, and when it works it’s a beautiful thing.
to attend AA/NA, obtain a Sponsor, and work the 12-steps. If they don’t we won’t sign-off on their program. Most Suboxone clinics require their participants to attend at least one counseling meeting a month. Unfortunately, this is almost completely useless unless the individual engages in a personal program of recovery that addresses not only the biological issues, but the social, psychological, and spiritual issues related to the disease, as well.
process the thorough try it requires to be effective. Therefore, Suboxone is a terrific option for chronic relapsers. You can’t generally get high from it, unless you haven’t used in awhile, or never used in the first place. You can’t overdose on it from use or abuse, and any other opioid you take while it’s in your system will be nullified and wasted.
The importance of looking after my mental health in recovery
Don’t face opioid addiction alone. Get help today. stedmanclinicaltrials.com
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Sign of the times Experts say the newly approved implant also provides a big boost to the concept of medication-assisted treatment (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 eld who saw complete abstinence as the only true sobriety. Many still hold that belief, but attitudes appear to be changing. Top government ocials 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 prescribe medications like buprenorphine, but they say too few patients receive the medication they need. [ "Opioid abuse and addiction have taken a devastating toll on American families.” - Dr. Robert M. Cali, FDA Commissioner “Scientic evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more eective in the treatment of opioid use disorder than short-term detoxication programs aimed at abstinence,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, in a statement. “is product will expand the treatment alternatives available to people suering from an opioid use disorder.” ]
edication-assisted treatment is growing in popularity and acceptance among addiction recovery professionals. And now it’s taken a revolutionary step forward that could oer renewed hope to thousands of people struggling with an addiction to opioids. is summer, the U.S. Food and Drug Administration approved a new buprenorphine implant to treat opioid dependence. Buprenorphine had previously been available only as a pill or a dissolvable lm 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. Cali 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.” e implant comes in the form of four one-inch rods that are placed under the skin on the upper arm.e implant must be administered surgically and comes with the possibility of certain side eects, but experts say it could be more convenient and more eective for patients.ey say by eliminating the need to take pills, ll 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.
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 lm tablet. In a study of the implant’s eectiveness, 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 ocials hope the new implant will lead more people to get MAT, increasing the number of successful recoveries across the country.
OPIOID ADDICTION: “LET’S TALK ABOUT IT.” Learn how faith communities can extend COMPASSION & SUPPORT
to people in recovery and to their families
State legislators focused on opioid addiction treatment and prevention in schools and prisons Thursday while reviewing bills that would both use medications to thwart overdoses and assist in recovery. A bill making its way through the Legislature would require all schools with grades 9 to 12 to have policies for training nurses on how to administer naloxone. The schools would also have to keep a supply of the medication ready. “The harsh reality is that opioids are killing thousands of people in this country, many of them young people,” Assemblyman Vincent Mazzeo, D-Atlantic, bill sponsor, said in a statement. “Narcan has been proven to save lives. Having it readily available in schools can help ensure that our schools are ready to respond in every emergency situation.” Several South Jersey schools, including Millville, Mainland Regional High School, the Egg Harbor Township School District and the Ocean City School District, already have such policies in place. As of 2017, New Jersey ranked eighth in the nation for drug overdose deaths among people ages 12 to 25, according to the national nonprofit Trust for America’s Health. There have been an estimated 654 overdose deaths in New Jersey since Jan. 1, according to the Department of the Attorney General.
The bill would require that nurses be taught how to use the anti-opioid drug and have a prescription standing order for naloxone to keep it in supply. There were more than 14,300 uses of naloxone in the state last year, state data shows. If passed, the law would also provide immunity from liability for school nurses and other employees when an opioid reversal is performed. Nearby, members of the Assembly Health and Human Services Committee reviewed a bill sponsored by Assemblyman Herb Conaway, D-Burlington, that would require state correctional facilities to offer inmates naltrexone and naloxone just before their release. Naltrexone, known by its brand name Vivitrol, is a type of nonopioid medication- assisted treatment (MAT) for a substance-use disorder. Studies have shown medication-assisted treatments like naltrexone, methadone and buprenorphine have successfully been used to reduce relapse rates and help people maintain recovery from opioid addiction. Vivitrol completely blocks the euphoric and sedative effects of opioids. Recipients often need a monthly shot of the medication administered by a medical professional.
At John Brooks Recovery Centers in Atlantic City and Pleasantville, Vivitrol is just one medication-assisted treatment offered to inpatient and outpatient patients, but it is coupled with counseling and other treatment education. Alan Oberman, CEO of John Brooks Recovery Center, said that while the bill looks well intentioned, giving one shot of Vivitrol, which costs about $1,000, to an outgoing inmate without follow-up or counseling only buys that person about three or four weeks of sobriety before they may use again. “It’s more than just giving an injection, which at least requires a nurse to do it, and many outpatient programs in the community don’t have medical staff there to do it regularly,” he said. While methadone and buprenorphine are MATs that have been on the market for some time, Vivitrol is relatively new. John Brooks and the Atlantic County jail teamed up last summer to create the state’s first mobile methadone program for inmates. Oberman said they now offer inmates Vivitrol, but they haven’t yet had any takers.
The harsh reality is that opioids are killing thousands of people in this country, many of them young people
Why Don’t They Just Quit?
might as well stick a bullet in your head... If you have been suffering from addiction, or know someone who is, treatment is available at Stedman Clinical Trials.
Hope for families struggling with addiction. www.stedmanclinicaltrials.com
no one suggested that she should not be treated because she was “getting what she deserved,” he said. “Yet somehow, if it’s heroin or cocaine or alcohol, we say, ‘Ahh, they decided that, they’re getting what they deserve,’” Christie remarked. HOW ADDICTION WORKS After satisfying basic human needs like food, water, sleep and safety, people feel pleasure. That pleasure is brought by chemical releases in the brain. This is according to Columbia researchers, who note that the disease of addiction causes the brain to release high levels of those pleasure chemicals. Over time, brain functions of reward, motivation and memory are altered. After these brain systems are compromised, those with addiction can experience intense cravings for substance use, even in the face of harmful consequences. These changes can stay in the brain long after substance use desists. The changes may leave those struggling with addiction to be vulnerable to “physical and environmental cues they associate with substance use, also known as triggers, which can increase their risk of relapse,” write Columbia researchers. no ne sug ested that she should not be treated because she was “getting what she deserved,” he said. “Yet somehow, if it’s heroin or cocaine or alcohol, we say, ‘Ah , they decided that, they’re getting what hey deserve,’” Christie remarked. HOW AD ICTION WORKS After satisfying basic human e ds like fo d, water, sle p and safety, people fe l pleasure. That pleasure is brought by chemical rel ases in the brain. This is ac ording to Columbia researchers, who note that he disease of ad iction causes the brain to rel ase high levels of those pleasure chemicals. Over time, brain functions of reward, motivation and memory are alter d. After these brain systems are compromised, those with ad iction can experience intense cravings for substance use, even in the face of harmful consequences. These changes can stay in the brain long after substance use desi t . The changes may leave those strug ling with ad iction to be vulnerable to “physical and environmental cues they as ociate with substance use, also known as trig ers, which can increase their isk of relapse,” write Columbia researchers.
not just a bad habit It’s NOT JUSTA BAD HABIT
not just a bad habit treatment and continued monitoring and support or recovery.
THE COLUMBIA RESEARCHERS DO HAVE SOME GOOD NEWS: Even the most severe, chronic form of the disorder can be manageable and reversible, usually with long term
Recent research and dialogue in the political sphere have brought long-simmering questions about addiction to the forefront: Is addiction truly a disease? Do addicts deserve to be treated like people who have a Recent res arch and ialogue in the political spher have brought long-sim ering questions about ad iction to the fore: Is addiction truly a disease? Do addicts deserve to b tr ated like people who hav a dise s that’s outside their control? disease that’s outside their control? While most researchers agree with the so-called disease model of addiction, stereotypes and cultural bias continue to stigmatize those with addiction because they made an initial choice to consume substances. However, Columbia University researchers point out that “choice does not determine whether 34 While most res archers agre with the so-called isease model of ad iction, ster otypes and cultural bias continue to stigmatize those with ad iction because they made an initial choice to consume substances. However, Columbia University res archers point out that “choice does not det rmine whether
something is a disease. Heart disease, diabetes and some forms of cancer involve personal choices like diet, exercise, sun exposure, etc. A disease is what happens in the body as a result of those choices.” Experts say that applying the distinction of choice to addiction creates biases that justify inadequate treatment. It begs the question New Jersey Gov. Chris Christie asked during a 2015 town hall meeting in New Hampshire. When Christie’s mother was diagnosed something is a disease. Heart disease, diabet s and some forms of cancer involve personal choices like diet, exercise, sun exposure, etc. A disease is what hap ens in the body as a result of those choices.” Experts ay that ap lying the distinction of choice to ad iction creates biases that justify inadequate treatment. It begs the question New Jersey Gov. Chris Christie asked uring a 2015 town hall me ting in New Hampshire. When Christie’s mother was diagnosed with lung cancer at 71 as a result of addiction to tobacco, he noted that with lung cancer at 71 as a result of ad iction to tobacco, he noted that
STEDMAN CLINICAL TRIALS 14506 Univsity Pnt Place Tampa, FL 33613 813-971-8311 www.stedmanclinicalials.c
For anyone looking for help with addiction, recovery is real, it’s great, it’s available... TODAY.
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