May 16, 2018

Lucemyra Reduces Opioid Withdrawal Symptoms

Lofexidine, the first medication for use in reducing symptoms associated with opioid withdrawal in adults, has been approved by the U.S. Food and Drug Administration. Lofexidine, an oral tablet, is designed to manage the symptoms patients often experience during opioid discontinuation.

Relieves Withdrawal Symptoms

Opioid withdrawal symptoms, which can begin as early as a few hours after the drug was last taken, may include aches and pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning, and feeling sick, among others. The product will be marketed under the brand name Lucemyratm.

In 2016, more than 42,000 people died from an opioid overdose, or approximately 115 people per day, according to the National Institute on Drug Abuse (NIDA). Although effective treatments exist for opioid addiction, painful and difficult withdrawal is one of the reasons treatment fails, and relapse occurs.

By alleviating symptoms associated with opioid withdrawal, Lucemyra could help patients complete their discontinuation of opioids and facilitate successful treatment. To date, no other medications have been approved to treat opioid withdrawal symptoms.

Lucemyra Available August 2018

Lucemyra will be marketed by US WorldMeds, a specialty pharmaceutical company that acquired a license for lofexidine from Britannia Pharmaceuticals in 2003. NIDA provided funding to US WorldMeds to support clinical trials to document the clinical pharmacokinetics of lofexidine and to test medical safety and efficacy of the medication, as compared to a placebo, among patients undergoing medically supervised opioid discontinuation.

Lucemyra is expected to be commercially available in the United States in August 2018.

Posted by Webmaster at 08:05 PM

Barriers to Getting Substance Abuse Treatment

For patients with substance use disorders seen in the emergency department or doctor's office, locating and accessing appropriate treatment all too often poses difficult challenges, according to a study in the Journal of Addiction Medicine, the official journal of the American Society of Addiction Medicine (ASAM).

Issues related to patient eligibility, treatment capacity, understanding of options, and communication problems all contribute to gaps in referral and delays to getting treatment for patients with substance use disorders, according to the new research by Claire Evelyn Blevins, PhD, of Warren Alpert Medical School of Brown University and Butler Hospital, Providence, RI; Nishi Rawat, MD, of OpenBeds, Inc., Washington. DC; and Michael Stein, MD, of Boston University and Butler Hospital.

Obstacles to Treatment

The ongoing opioid crisis has drawn attention to the widening gap between the high need and limited access to substance use treatment in the United States. A recent Substance Abuse and Mental Health Services Administration report found that of 21.7 million Americans in need of substance use disorder treatment, only 2.35 million received treatment at a specialty facility. Yet there is little information on the organizational-level barriers to treatment for substance use disorders.

To address this issue, Dr. Blevins and colleagues performed a series of interviews with 59 stakeholders in the treatment referral process. The study gathered input from those who make referrals for substance use treatment, including emergency medicine physicians, addiction specialists, and other medical providers; as well as those who receive referrals, including substance use treatment facility staff and administrators.

Four Broad Themes

Analysis of the interviews identified four broad themes:

Patient Eligibility. Healthcare providers face difficulties in determining whether patients meet criteria for admission to a particular treatment center, including the application of treatment eligibility criteria. "Eligibility requirements may prevent a patient from entering a treatment center," the researchers write.

Treatment Capacity. Even if a patient is eligible, providers have trouble finding out whether space is available. "Despite the need for services, treatment centers may not run at capacity, because of frustrations encountered and time wasted on the referral and admission process."

Knowledge of Treatment Options. Providers may not understand the levels of available care for substance use treatment, and how to select the best treatment for their patient. "After determining appropriate level of care, a provider must then find a program that meets the patient's needs, which becomes more difficult with the differences in terminology and program guidelines."

Communication. Difficulties in communication between referring providers and treatment facilities can contribute to delays to starting treatment. The need for direct referral - "from the emergency department to a bed" - is particularly high for patients with opioid use disorders.

System Needs Improvements

"Access to substance use disorder treatment is often a maze that can be difficult to navigate for both providers and patients," Dr. Blevins and coauthors write. Based on the themes identified, they make recommendations for improvement in the referral process, including a database of clear eligibility criteria, real-time information on treatment capacity, and increased education and training for providers on substance use treatment.

They also propose ways to improve communication and reduce treatment waiting times, including new information technologies. The researchers write: "By improving systems that enhance communication across organizations, patient referrals may be more easily completed, improving access to care and expanding the use of appropriate treatments for the many patients in need."

In an accompanying commentary, David L. Rosenbloom, PhD, of Boston University School of Public Health discusses the underlying reasons for the current "dysfunctional referral system." He notes that referrals for other chronic diseases "may be more effective because they are to 'in-house' affiliated providers." Dr. Rosenbloom writes: "The standard of care should be to stabilize, initiate treatment, and provide a hands-on transfer to an entity that can complete a diagnostic assessment and provide evidence-based treatment" for patients with substance use disorders.

Posted by Webmaster at 08:39 AM

March 06, 2018

Alcoholism 'Wonder Drug' Is a Dud

Baclofen, used to treat spasticity, was touted as a 'wonder drug' for alcohol use disorders, but researchers found it is no more effective than a placebo for reducing alcohol consumption and alcohol cravings.

Baclofen is a medication which has been used since the 1970s as an anti-spasticity treatment. More recently it has been used as a treatment for alcohol use disorders.

Baclofen has a key advantage compared with currently licensed medications: it is excreted largely through the kidneys. It is therefore possible to give baclofen to people suffering alcohol-related liver disease, a patient population with very high needs, and who often can't tolerate licensed drug treatments.

'Wonder Drug' It's Not

Many studies have found baclofen to be successful in treating alcohol use disorders, some have claimed it a wonder drug capable of curing alcoholism.

Following a number of successful clinical trials the use of use of baclofen increased massively and sales of the drug have soared in some countries.

In more recent years, there have been a growing number of studies which directly compare baclofen against placebo on a number of outcome measures. Often these outcome measures are drink-related, e.g. rate of abstinence at the end of the medication trial, or number of heavy drinking or abstinent days during the trial.

However, there are other measures, potentially related to why baclofen might work (i.e. its mechanism of action). Several possibilities have been identified; firstly baclofen may reduce craving for alcohol, secondly there are reports that baclofen reduces negative mood states, such as anxiety and depression, which are known risk factors for harmful drinking.

Abstinent Rates Actually Increased

Researchers, Dr Abi Rose and Dr Andy Jones, from the University's Addiction Research Team conducted a meta-analysis on all 12 clinical trials comparing baclofen with placebo on at least one of the described drinking outcomes, craving, anxiety, or depression.

Meta-analysis is an advanced statistical procedure that allows the researcher to merge the results of all the studies regarding a specific topic into a quantitative measure representing the size of the overall effect of one variable on another variable. Thus, meta-analysis provides more accurate and reliable outcomes compared to the single experiment.

The researchers found that baclofen led to higher abstinent rates compared with placebo, and that eight individuals would need to be treated with baclofen for one to remain abstinent due to the medication.

However, all other outcomes failed to show an effect of baclofen: baclofen did not increase abstinent days or decrease number of heavy drinking days during treatment, neither did it reduce rates of alcohol craving, anxiety or depression.

Effectiveness Questioned

Dr Rose, said: "Our research highlights several issues with the existing body of trials. Many of the studies only recruited a limited number of patients, so maybe too small to find an effect.

"The existing trials also differ on a number of factors, such as the dose of baclofen given and the length of treatment. Importantly, the pharmacokinetics of baclofen (how it moves in the body) are not well-understood, so there may be individual factors influencing the effectiveness of baclofen that we do not yet understand."

Dr Jones, said: "This new meta-analysis shows that baclofen is no more effective than placebo on a range of key outcome measures, suggesting that the current increasing use of baclofen as a treatment for alcohol use disorders is premature."

Source: Rose AK, et al. "Baclofen: its effectiveness in reducing harmful drinking, craving, and negative mood. A meta-analysis." Addiction 26 Feb. 2018

Posted by Webmaster at 08:44 AM

February 23, 2018

Long-Term Recovery Increases Quality of Life

Receiving successful treatment for an alcohol and drug problem can result in steep increases in physical, psychological, and social well-being, according to the Research Society on Alcoholism.

Alcohol and other drug (AOD) treatment and recovery research typically focuses on outcomes such as 'days abstinent.' Yet the degree to which individuals may be functioning better physically, socially and psychologically, how happy they may be, and their levels of self-esteem may be equally important as measures of progress.

Little is known about whether such changes occur, when they may occur, and for whom, as people progress in recovery. This study sought to improve understanding of recovery milestones and points of vulnerability and growth.

Five Measures of Well-Being

Researchers analyzed a national, probability-based, cross-sectional sample of US adults who answered yes to the question "Did you used to have a problem with alcohol or drugs but no longer do?"

Of the original sample of 39,809, the final weighted sample responding positively was 2,002 (60% men, 40% women). Relationships between time in recovery and five measures of well-being – quality of life, happiness, self-esteem, recovery capital, and psychological distress – were examined for two temporal periods: the first 5 years, and the first 40 years, after resolving an AOD problem.

In general, recovery from AOD problems was associated with dynamic improvements in indices of well-being. This was the case during the first five-year span of time, with the exception of the first year, where self-esteem and happiness initially decreased before improving.

Steep Decline in Distress

Over the first six years, there were initially steep increases in indices of well-being – as well as steep drops in distress – followed by shallower increases later.

The authors noted that during early recovery, women, mixed race/Native American groups, and those suffering with opioid- and stimulant-related problems faced ongoing challenges in well-being that suggest a greater need for assistance.

Source: Kelly JF, et al "Beyond Abstinence: Changes in Indices of Quality of Life with Time in Recovery in a Nationally Representative Sample of U.S. Adults." Alcoholism: Clinical & Experimental Research Feb. 23, 2018.

Posted by Webmaster at 11:06 AM

February 10, 2018

Follow-Up Increases Naltrexone Compliance

Symptoms of alcoholism make it more difficult for some people to regularly take the prescription drug naltrexone, which could help treat their disease, a researcher at Oregon State University has found.

The finding helps researchers better understand how to intervene with patients to improve the effectiveness of the medication, said Sarah Dermody, an assistant professor in the School of Psychological Science in OSU's College of Liberal Arts.

"The assumption is the medication is prescribed, so it's going to work, but the patient has to take the medication in order for it to work," Dermody said. "This tells us we need to do more than write a prescription. Having some sort of reoccurring contact with the patient is really important."

The findings were published in the Annals of Behavioral Medicine.

Reduces the Desire to Drink

Dermody studies risky behaviors such as alcohol and nicotine use with the goal of better understanding factors that contribute to alcohol and nicotine use and how best to intervene with problematic use of these substances.

Naltrexone, which works at the receptor level in the brain to reduce a patient's desire to drink, is one of just three medications that is approved by the Food and Drug Administration to treat alcohol use disorder.

The drug is believed to be effective, but only if it is taken as prescribed. Studies show that adherence to the daily medication regimen is poor. The researchers' goal with the new study was to better understand medication usage and factors that influence it.

Adherence Decreases Over Time

They followed a group of 58 people who were prescribed to take naltrexone daily for eight weeks to either reduce or stop drinking. The researchers also studied the effectiveness of a mobile health intervention designed to help people adhere to the medication. In response to daily text messages, patients reported their previous day's alcohol use, cravings and any side effects from using naltrexone.

The researchers found that adherence to the drug decreased over time, with a drop from approximately eight in 10 patients taking the medication at week one to approximately four in 10 patients by week eight. On days when participants completed daily text message assessments, their odds of taking the medication increased by more than two-fold compared to days when the assessments were not completed.

They also found that they could predict who would stick with the medication and who wouldn't, and the factors that influence adherence to the drug included symptoms of the underlying disease. Patients were less likely to take their medication on days they after they drank heavily; on weekends; or when cravings were strong.

Avoidance When Needed Most

"Weekends are a huge part of people's drinking life. That is often when people drink more heavily and when their cravings are strongest," Dermody said. "But they also tend not to be taking naltrexone on the days when the medication is particularly needed."

More research is needed to understand how best to address symptoms that influence medication adherence, Dermody said. Promoting medication adherence after heavy drinking episodes or strong cravings is critical, Dermody said. Ongoing daily contact with the patient could also help.

"We found that some sort of daily contact with the patient is important. It does not have to be human to human," she said. "It could be a mobile phone app that tracks a patient's symptoms and tailors feedback to their needs."

Posted by Webmaster at 02:06 PM

November 08, 2017

New Program Closes Gap in Addiction Treatment

A new program at Boston Medical Center's Grayken Center for Addiction is showing that connecting patients to addiction treatment when they are hospitalized for other conditions can be a powerful tool in closing a gap in addiction treatment. In fact, early results show that many of these patients continue treatment after they are discharged, underscoring the importance of reaching patients who might otherwise not get treatment for their addiction.

Approximately 17 percent of patients admitted at BMC have an active substance use disorder. This led providers to look for new ways to engage patients in addiction treatment when they were already here.

To accomplish this, they developed and implemented an inpatient addiction consult service, which is staffed by a multidisciplinary care team with expertise in treating addiction.

Ready for Treatment

"In order to help curb the epidemic, we need to take every opportunity to engage patients with substance use disorders and get them into treatment when they are ready," said study lead author Paul Trowbridge, MD, and graduate of BMC's addiction medicine fellowship. "This service will not only prove beneficial to patients, by helping them get access to evidenced-based treatment, but also to the health care system by reducing costs and readmissions."

Researchers found the initial results promising: Methadone treatment was initiated for 70 patients and 76 percent were linked to a methadone clinic upon discharge. Upon follow up, 54 percent were still receiving methadone at 30 days, 39 percent at 90 days, and 29 percent at 180 days.

Buprenorphine was initiated in 40 patients as a result of the consult, and 49 percent were linked to an outpatient clinic at discharge. Upon follow up, 39 percent were still engaged in treatment at 30 days, 27 percent at 90 days and 18 percent at 180 days.

Treating the Root Cause

"Like heart disease can cause a heart attack or a stroke, addiction causes many acute injuries requiring immediate attention, but we can't simply treat that issue without delving deeper to address the root cause," said Alex Walley, MD, MSc, a general internist at BMC's Grayken Center for Addiction who also oversees the addiction medicine fellowship. "Our goal is to engage willing patients in treatment and work with them on a plan that will keep them healthy and safe now and in the future."

The authors note that treatment is not one size fits all and that there is a need for additional treatment programs and services that meet the needs of even more patients both in the short and long term.

This study was published in the Journal of Substance Abuse Treatment.

Posted by Webmaster at 03:56 PM

September 06, 2017

Opioid Abuse Can Be Treated in Primary Care

A new model of collaborative care - combining substance abuse treatment with regular medical care - has been found to be more accessible, more effective and at a lower cost that traditional speciality care methods, according to a new RAND Corporation study.

Patients who enrolled in a program that combined substance abuse treatment with primary medical care were more than twice as likely to receive treatment for opioid or alcohol abuse, as compared to peers who received usual primary care services, according to the study.

The patients in the collaborative care model also were significantly more likely to report abstinence from opioids or alcohol six month after beginning care, a key marker to successful recovery. The findings are published online by the journal JAMA Internal Medicine.

Increasing Access to Treatment

"This new model of integrating treatment for substance use disorders with a patient's primary medical care could expand access to drug treatment at a lower cost and in a more accessible fashion," said Dr. Katherine E. Watkins, the study's lead author and a senior physician scientist at RAND, a nonprofit research organization. "This is a way to increase access to evidence-based substance use treatment, without having to convince patients to go to a specialized drug treatment center."

Deaths in the United States are rising from increases in drug overdoses and alcohol-related liver disease, yet many substance use disorders continue to be under identified and undertreated.

While treatment in specialty care settings is important for people who have severe dependence, researchers say that access to such care is limited and the stigma associated with drug treatment means that specialty care alone is insufficient to address the nation's treatment needs.

Collaborative Care System

The RAND study involved 377 people with opioid or alcohol abuse disorders who received medical care at two locations operated by a safety-net medical provider in the Los Angeles area. The clinics were part of a federally qualified health center.

Participants were randomly assigned to receive their medical care from either the clinics' usual primary care providers or from providers who were partnered with therapists and care coordinators who received special training to provide evidence-based substance use treatment.

The collaborative care system was designed to increase delivery of a six-session brief psychotherapy treatment and/or medication-assisted treatment to reduce cravings for opioids or alcohol. Patients receiving usual care were told the clinic provided substance use treatment and were given a phone number to schedule an appointment, as well as a list of community referrals.

Works Better Than Specialty Care

Most of the patients in the study had challenges that were viewed as an obstacle to receiving successful treatment, with nearly half of the group being homeless at the time of enrollment.

Among those treated in the collaborative care model, 39 percent received some type of substance abuse treatment, compared to 16.8 percent among those treated in the usual primary care system.

After six months, 32.8 of the participants in the collaborative care model reported that they had abstained from opioids or alcohol in the previous month, compared to 22.3 percent treated in the usual primary care system. Researchers say that among people with substance abuse problems, abstinence is linked to a lower likelihood of relapse compared with nonproblem use.

"Our findings suggest that it is possible to successfully treat people who are addicted to opioids or alcohol in a primary care setting," Watkins said. "The collaborative care model can be a lower-cost and more-accessible way to treat opioid addiction than expanding the nation's supply of specialty care clinics."

Posted by Webmaster at 07:45 PM

August 14, 2017

12 Steps Improve Youth Treatment Outcomes

A treatment program for adolescents with substance-use disorder that incorporates the practices and philosophy of 12-step programs like Alcoholics Anonymous (AA) produced even better results than the current state-of-the art treatment approach in a nine-month, randomized trial.

The results of the study, led by a Massachusetts General Hospital (MGH) psychologist, are published online in the journal Addiction.

"While all adolescents can improve when they receive well-articulated substance-use disorder treatment, we showed that adding a 12-step component to standard cognitive-behavioral and motivational strategies produced significantly greater reductions in substance-related consequences during and in the months following treatment," says John Kelly, PhD, director of the Recovery Research Institute in the MGH Department of Psychiatry, who led the study. "It also produced higher rates of 12-step meeting participation, which was associated with longer periods of continuous abstinence."

Combining Treatment Approaches

While it is common for adolescent treatment programs in the U.S. to link patients to mutual-help organizations like AA, Narcotics Anonymous (NA) or Marijuana Anonymous (MA), the effectiveness of combining 12-step approaches with motivational enhancement/cognitive-behavioral therapies has not been clear because there has been no well-defined treatment protocol integrating both approaches for young patients.

The intervention developed by the team was based on motivational/cognitive-behavioral approaches but also included information about and the kinds of discussions featured in 12-step program meetings.

Conducted at the MGH Center for Addiction Medicine, the study enrolled 59 participants, ages 14 to 21, who met substance-use disorder criteria and had been actively using within the past 90 days. Participants were randomly assigned to either a standard motivational enhancement/cognitive behavioral program or the Integrated Twelve-Step Facilitation (iTSF) program.

Reducing Relapse Risk

Both programs featured 10 consecutive weekly sessions -- two individual sessions with a therapist and eight group sessions. The motivational enhancement/cognitive-behavioral approach was designed to enhance adolescents' motivation for change towards remission and recovery. Sessions focused on teaching and practicing cognitive-behavioral relapse prevention and coping skills and included setting and reporting on weekly treatment goals.

Group sessions for the iTSF group included discussions of topics such as changing social networks and reducing relapse risk. Two of the sessions featured young members of NA or MA who shared their own experiences with addiction and recovery.

"That peer-to-peer aspect was probably the most powerful in disabusing young people of the negative stereotypes they often hold about 12-step members and about recovery more broadly," says Kelly. "Similar-aged peers who are in recovery seemed much better able to capture the attention of participants than clinic staff."

Fewer Substance-Related Consequences

Along with the weekly reports at their sessions, participants were formally assessed upon entering the study and then three, six and nine months later. At the end of the study period, both groups showed similar improvements in the primary outcome, percent days abstinent. But those in the iTSF group had greater attendance at 12-step meetings during the three months that included the intervention.

Participants in the iTSF group also reported significantly fewer substance-related consequences - things like feeling unhappy, guilty or ashamed because of their substance use; neglecting responsibilities; taking risks; having money problems; damaging relationships with family and friends, and having under-the-influence accidents.

The fact that the greater rate of 12-step attendance among the iTSF group was not maintained after the intervention program may indicate the need for a longer treatment program or regular, follow-up visits.

Longer Term Care Needed

"We want to replicate and extend the testing of this treatment even further to determine the benefits of longer term care," Kelly explains. "We know that the transition to adulthood is fraught with relapse risks for young people recovering from a substance-use disorder, so some kind of regular but brief 'clinical recovery check-up,' like what is common for other chronic conditions like diabetes or hypertension, could improve outcomes."

Kelly, who is the Elizabeth R. Spallin Associate Professor of Psychiatry in the Field of Addiction Medicine at Harvard Medical School, adds, "In countries like the U.S., the greatest health risks for young people by far are from alcohol or other drug use. Cognitive-behavioral and motivational programs are evidence-based, popular approaches for addressing youth substance-use disorder, and now these data suggest that integrating these approaches with 12-step philosophy and practices can further help reduce the impact of substance use in their lives and potentially facilitate higher rates of abstinence.

"Given the prevalence of substance-use disorders among young people, having treatments that are both effective and cost-effective -- linking patients to free and ubiquitous community resources -- is needed and welcome."

Posted by Webmaster at 03:40 AM

Trusting Counselor Vital to Treatment Success

A positive, trusting relationship between counselor and patient, known as a "therapeutic alliance," can be key to successful treatment of alcohol use disorder, a study finds. Gerard Connors, PhD, senior research scientist at the University at Buffalo Research Institute on Addictions, studied more than five dozen people engaging in a 12-week program of cognitive behavior therapy for alcohol use disorder.

Patients who reported the most positive relationships with their counselors on a session-to-session basis had fewer days of drinking and fewer days of heavy drinking between treatment sessions than patients whose relationship was not as positive.

Positive Relationship Yields Better Results

The results indicate that efforts to ensure a good match between patient and counselor can have considerable benefits to the patient's recovery, Connors says. Further research on what factors lead to strong therapeutic alliances in alcohol treatment could be warranted.

Historically, there was an expectation that the most effective process to treat alcohol use disorder involved therapists confronting their clients about their behavior. However, Connors' work over several years, along with other emerging research, has shown a more positive relationship between therapist and client yields better results.

"Many recent studies have recognized that a positive therapeutic alliance between a therapist and client is necessary for achieving behavior change, but much less has been known about how alliances operate across a full course of treatment," Connors says.

Risk of Dropping Out of Treatment

"By studying the alliance on a session-to-session basis, we could see how a fractured alliance at a given point in time interferes with the pursuit of treatment goals by running the risk of a client dropping out of treatment," he says. "Therefore, it's important for the therapist to continue assessing the alliance throughout the entire course of treatment."

The study also showed a positive alliance was even more critical for patients who had not made changes in their drinking prior to starting treatment. "In contrast, patients who had already reduced their drinking prior to entering treatment were not as dependent on the therapeutic alliance to continue the process of behavior change," Connors says.

Posted by Webmaster at 03:15 AM