This week, doctors received an innovative new tool in the fight against the opioid addiction crisis . The FDA gives the green light to a new mobile medical app called reSET-O, designed to help patients with opioid use disorders in outpatient care.
"As part of our efforts to address misuse and abuse of opioids, we have focused primarily on new tools and therapies that allow more people with opioid-related drug use to successfully treat their addictions," said FDA Commissioner Scott Gottlieb , MD, in a press release from 1
The goal of the app is to help people find themselves in recovery.
The reSET-O app is a prescriptive form of cognitive-behavioral therapy (CBT) that is not given as a stand-alone treatment, but as a way to help patients stay in treatment longer in an intensive outpatient treatment program FDA. The app was approved by the FDA (19459014), not approved by the FDA, meaning that it is similar to another legally distributed device. In this case, this is the original version of the reSET app, which was approved by the FDA in 2017 which, however, was used for outpatient treatment of addictive drugs related to alcohol, cocaine, marijuana and stimulants no opioids.
"Often, patients on the road to recovery are weakening their commitment to staying in treatment," said Drs. Gottlieb in the press release. "The key to success for Americans suffering from an opioid malfunction is providing more options and providing adequate support in addressing treatment challenges."
After a person with opioid use disorder (OUD ), reSET-O is prescribed, it is downloaded and installs the product from the App Store with an access code from their doctor.
Then they start the program, which consists of 67 different therapy sessions that build on each other in the course of 12 weeks. med. Yuri Maricich, head of the medical department and head of clinical development for Pear Therapeutics told the company that developed the app, SELF.
The content of the app is largely based on a well-researched addiction-specific form of CBT. Like Dr. Maricich describes it as the Community Reinforcement Approach (CRA), which aims to help people assess and rearrange their lifestyle and environment (eg, their social support system and social support system) family relationships), so that a sober life is more rewarding than the abuse of drugs and the learning of coping skills.
The clinical study found that patients who used the reSET-O app remained on treatment longer than those who did not. [19659010InderPeerreviewstudypublishedin Journal of Consulting and Clinical Psychology in 2014, the app was tested as an adjunct to two of the best evidence-based therapies available for the treatment of opioid addiction: Assisted Treatment (MAT) and Emergency Management (CM). MAT is the use of certain medications – buprenorphine in this case – to alleviate the severe physical symptoms and strong psychic desires that accompany the withdrawal of opioids, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). CM is the use of motivational incentives to promote abstinence, such as the National Institute for Drug Abuse (19459033) (NIDA), such as cash or vouchers. In this study, participants were tested three times a week for opiates and cocaine and could earn a maximum of $ 997.50.
All 170 participants in the study, along with a twelve-week CM and MAT-based treatment program, included "minimal" counseling (every two weeks 30 minutes). About half of these participants also took advantage of the reSET-O app, in which they completed interactive lessons that typically include a CBT component and skill building exercises. At the end of the 12 weeks, the App Group had a total retention rate of 80.4 percent versus 64.1 percent for the no-app group. A certain part of the app group also had more days of sobriety under control at the end of the trial (more on that in a nutshell).
Here's how the app works: Each lesson consists of text, images, video and audio and takes about 15 to 20 minutes. At the end of each lesson is a quiz that allows users to be fluently assessed in this concept. Maricich. The patient must reach 100 percent to progress. The first 31 modules are core lessons to be repeated to repeat the key concepts. Maricich. Upon successful completion of each quiz, the user may rotate a prize wheel containing either a congratulatory message of progress or a small digital gift card. (It's essentially an algorithm-simplified form of emergency management, explains Dr. Maricich.)
An example of a core lesson is learning skills to refuse drugs by analyzing situations in which they did it or almost did. Each time a patient has a relapse or is attempting to do so, the patient uses the exercise as an exercise to assess the specific circumstances – where they were, the time of day, their mood, and the people they were with – to help them recognize patterns of their own behavior and find out what they might do differently next time. Mastering this concept in the app could be useful to someone if they feel prone to relapses. "In a moment of difficulty or stress, they need to be able to quickly regain this ability and apply it in real life," explains Maricich.
In addition to the educational component, the app facilitates communication between the doctor and the patient between visits. The app has a feature that allows patients to report cravings and triggers themselves, and record their use (or non-use) of buprenorphine, according to the press release which the physician can monitor from a dashboard of their own. The doctor may also enter the results of the patient's urinalysis. A negative drug test gives them another way to turn the price wheel, Dr. Maricich (in addition to the reward for vouchers).
Although the app can help people stay in treatment, it has not been shown that they actually ban the drug use.
Among the patients who were first treated for OUD, there was no statistical difference in the study when it came to abstinence, nor was it the longest continuous abstinence (the longest period in which they went) without Use during the study) or total abstinence (the total duration of time they did not use during the study).
Interestingly, the results were much more dramatic in individuals who had been treated at least once before an OUD. On average, adding the app to their treatment program increased their longest continuous abstinence (LCA) by 15.1 days (from 46 to 61.1) and total abstinence (TA) by 17.8 (from 54.8 to) 72.6). The authors of the study hypothesized that those who were previously treated could build on the successes achieved there.
However, the FDA rejects the claim that the app is specified to reduce the use of illegal drugs. "The FDA reserves the right to consider the available data and found that the data was insufficient to support a claim to abstinence at that time," says Dr. Maricich. Therefore, the company must include this restriction of use, Dr. Maricich: "ReSET-O has not been shown to reduce the use of illicit drug use or to improve abstinence in OUD patients."
There are some significant study limitations, according to the authors of the reSET-O study. For example, there is no data on how the participants succeeded after completing the 12-week study. Therefore, it is impossible to say if the app had a significant impact in the long term. Another topic: Study participants used a desktop version of the app on a computer in the clinic – not on their own phone and at their own time. It is not clear whether the visit to the clinic is necessary to ensure that the patients complete the lessons, the researchers note. And with only 170 participants, the study is relatively small.
The FDA currently believes there is a lack of evidence when reSET-O can help reduce drug use and increase abstinence – which is ultimately the ultimate goal of treating abusive behavior. "Treating treatment is always a good thing when it comes to addiction," says Timothy Brennan director of the Addiction Institute on Mount Sinai West and Mount Sinai St. Luke's Hospital. "But the final is really a drop in drug use, and that has not been shown yet."
Including an app in the recovery model is exciting and potentially helpful, but not a solution yet.
"There is an increasing interest in digital therapeutics and technology-based interventions to treat substance use disorders because they have the potential to reach many people easily and efficiently." med. Larissa Mooney Psychiatry at UCLA and director of the UCLA Addiction Medicine Clinic, tells SELF. "They want to use as many tools as possible to help individuals make progress on recovery," she says, stressing that an app like reSET-O is just that – a tool.
"I think it's a great idea Look at Mobile Tech and the Internet when you involve people in the treatment, because we certainly know that people are on the phone for a long time," says Dr. Brennan "But yes, I think we have a way to improve the effectiveness of these apps."
In other words, doctors will welcome any help they can do to help people overcome the addiction, but nobody in Medicine expects Silicon Valley to find a quick fix for such a large and complex problem. "Addiction and biology and psychiatry – they do not work that way," explains Dr. Brennan. "We will not hack through the opioid crisis."  Related: