Dr. Felix Horng Recommends
New Treatment for Alcohol Dependence
Woodbury Medical Group’s Dr. Felix Horng recently presented the findings from his Vivitrol study to a panel of physicians and medical practitioners at the Long Beach Convention Center.
What is Vivitrol? Vivitrol is an injectible form of naltrexone, a drug primarily used to treat alcohol dependence and in some cases, to treat opioid dependence.
What does Vivitrol do? Naltrexone blocks the addict’s craving for alcohol and removes the euphoria from its ingestion. While taking Vivitrol, the addict does not gain the normal “buzz” associated with drinking, thus removing the positive reinforcement and discouraging alcohol use. A person who is on Vivitrol and drinks alcohol will still be impaired.
What is Vivitrol NOT? Vivitrol should not be confused with Naloxone (Narcan), which is used in emergency cases to reverse opioid overdose. It is also not Disulfiram (Antabuse), which is used in alcohol dependence to give a severe unpleasant reaction when alcohol is ingested, thus eliminating motivation to drink through punishment.
How is Vivitrol different from Oral Naltrexone? Oral Naltrexone was originally approved by the FDA in 1995. The effects of the oral drug lasted one day and people who wanted to drink simply stopped taking the medication and waited one day before resuming. Vivitrol, approved by the FDA in April of 2006, is an injectible, extended release version of Naltrexone. The effects of the injection lasts a full month. If someone wanted to drink while on Naltrexone, they might have to wait up to 30 days before the medicine wore off. Using Vivitrol is a tremendous advantage as most relapse occurs within the first 30 days of attempting abstinence.
How does Vivitrol compare to a Placebo? Using a six month, multi-center, double blind study, results revealed that Vivitrol proved 90% more effective than placebo with a 97% reduction in drinking days over the baseline. (n=56 control, n=28 placebo, n=28 vivitrol, p=0.005)
What are the long-term effects of Vivitrol? After 180 days on Vivitrol, 41% of the patients remained abstinent from alcohol, whereas 11% of patients on the placebo remained abstinent.
Does Vivitrol have any adverse effects? Vivitrol is contraindicated in acute hepatitis. It is recommended that liver function tests are obtained before beginning treatment with Vivitrol. The most common side effects reported were nausea, headache, dizziness, fatigue, and injection discomfort. These reported side effects tended to decrease in severity with each subsequent injection of Vivitrol. It should be noted that if a patient goes to the emergency room and requires pain medication, they should communicate that they are using Vivitrol to the ER doctor. The ER doctor will need to increase the dosage of pain medication or anesthesia in order to compensate for the blockage of pain receptors due to the use of Vivitrol.
How was the study designed? The goal of the program was to determine the feasibility of integrating the Vivitrol treatment into a residential and outpatient program for 4 months. Medications were donated for the study by the pharmaceutical company. Patients entered the study on a volunteer basis.
What were patient results? Patients overall reported high level of satisfaction. 100% of eligible patients were still with the program 1 month later and received a subsequent treatment. No adverse reactions were reported. Patients reported a reduced urge to drink and a reduction in overall alcohol ingestion.
Did all eligible candidates participate? A few patients did not participate in the program.
For those declining meds:
1 client had acute hepatitis (contraindication)
3 clients report injections in general as a trigger for relapse
3-5 clients “didn’t want chemical assistance”
1 client was pregnant, and removed from consideration
2 residential clients no-showed for appointments
2 outpatient clients no-showed for appointments
Why did patients decline? Resident clients reported that the intensity and stressfulness of a residential drug treatment program interfered with overall compliance to instruction, resulting in no shows. Voluntary medications become yet another item to worry about. As Vivitrol becomes more formally integrated into residential programming, compliance and enthusiasm for the medication will likely increase. For outpatients it is speculated that no-shows were the result of a lack of integration with the medical program and outpatient residential program. This resulted in wider variability in outpatient scheduling and availability. A formal on-site program at the outpatient center would improve both compliance and acceptance.
Would staff accept the program? There was an in initial concern that residential staff would be resistant to the Vivitrol treatment because counters traditional cultural bias of complete abstinence from all chemical dependence, including medicines. As a result, study designers feared overt or subconscious undermining of the program.
How did the staff prepare? In preparation for the study, the medical staff had several meetings with the pharmaceutical company, residential drug treatment management, residential intake department, and residential drug treatment clients, prior to initiation of the pilot.
What ongoing staff preparation was required? Pharmaceutical reps were in routine contact with the medical director by email and phone. The medical director met with the medical department once a week, the intake department once a month and the pharmaceutical rep met with the medical staff once a month.
What were the results? There was an extremely high acceptance rate among staff, especially the intake staff which were very enthusiastic - even offering suggestions and improvements. A surprising result was the enthusiasm of members of the community assessment centers, which requested program integration in the future. Community assessment centers reported trouble getting alcoholics into drug treatment programs, due to the high incidence of relapse. In other words, the alcoholics were too inebriated and unstable, to become fit for formalized treatment programming. The result may be a better role for Vivitrol with the community assessment centers.
What are the challenges and pitfalls? Vivitrol is expensive ($700/month), but when compared to the cost of a relapse, the costs could be justified. Any program looking to incorporate Vivitrol will need to design and organize infrastructure and protocol. In addition, there are startup capital requirements and a need for appropriate marketing materials. Finally, staffing needs must be addressed as well as cultural conversion and acceptance of the medication.
What is the overall conclusion? Overall the Vivitrol study yielded good results. Patients were satisfied and the staff was enthusiastic. There were minor organizational process issued that should be correctable. We would recommend Vivitrol as part of treatment for alcohol abuse.
About Woodbury Medical Group: WMG provides both urgent and primary care to patients in the Irvine area. Featuring Hoag-affiliated Board-Certified family physicians, who each bring with them a remarkable education, experience and track record, the doctors provide complete and comprehensive care, serving all ages and health concerns. Conveniently located in the Woodbury Center at the corner of Irvine Boulevard and Sand Canyon, WMG has been delivering award-winning medical care since it opened its doors in January 2007. The WMG provides family medicine and urgent care services to the communities of Woodbury, Northwood, Orchard Hills, Great Park, Woodbridge and Portola Springs. For more information, please visit www.woodburymedical.com.
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