Lloyd Gordon, III, MD is the Medical Director at The Ranch Tennesse. I was somewhat discouraged with the recent article cited in the ASAM News called "Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxon Treatment for Prescription Opioid Dependence" with the lead investigator being Roger D. Weiss, MD, of Boston University. The article described adjunctive counseling vs. standard medical management in a group of prescription opiate dependent patients on Suboxone. It was a two phase trial in which failures in the 1st phase went into the 2nd phase. The article noted that the success in the first phase of patients that were taken off Buprenorphine subsequently was 10%. At the end of the second phase, those that were successes, which was reported that approximately 50% also went back to using prescription opiates at a level of 90%. This again was just a 10% "success" rate. The article also noted that there was no difference between standard medical management, which was basically just seeing the doctor vs. adjunctive counseling with a trained substance abuse professional. The spin on the article seemed to be that if we could keep everybody on Buprenorphine, we would have less opiate use. As I was reading through the brief summary of the article, I noted that they talked about decreasing opiate use as opposed to stopping opiate use. I then looked up the article from the Archives of General Psychiatry. The successful outcome in Phase I was defined as completing 12 weeks with self-reported opiate use of no more than four days in the month and absence of two consecutive opioid positive urine drug screens. Additionally, there was no other substance use disorder treatment other than self-help and no more than one missing urine sample during the 12-week period for a successful end point. The article cited the COMBINE Study as their rationale for the above successful outcomes. In the Phase II trial, there again seemed to be no difference in medical management or counseling. I think that this type of study, which focuses on decreased use as opposed to abstinence, doesn't paint a true portrait. I think the COMBINE Study was flawed. I do not know of any clinician that currently bases clinical decision making on the COMBINE Study. We have had Methadone maintenance clinics for over 40 years, which have tried to maintain opiate dependent patients on opiates with the hope of improvement in function and decreased consequences of use. There has been some very limited success with this approach and I do not think that Buprenorphine will significantly alter what is already available in the literature regarding Methadone treatment. Results are generally not long-term and are only in the realm of a harm reduction strategy. I think that there are significant reasons for these results. We did our own studies with Buprenorphine a number of years ago and had very little success with outcomes that were measured through one year. To stay abstinent and to be in recovery, a patient has to make changes. As processes from psychiatry and psychology meld into biochemistry and physiology, we realize that human behavior is based on chemical reactions. As we have learned from classic operant conditioning in psychology, behaviors are reinforced either by a reward for the successful behavior or the removal of a noxious stimulus at the time of the successful behavior. This is how we learn tasks, be it a golf swing, walking on a new prosthetic leg, solving a math problem, or mastering a game of Bridge or Chess. Change for human beings is very difficult and requires motivation and work. To successfully learn a new activity, I must pursue it and get feedback on my level of expertise. That feedback is either a sense of pride and accomplishment at improving my ability to do the activity or frustration from unsuccessful attempts to do the activity. In short, I find what works and what does not work. I am both driven by the uncomfortable feelings of being unsuccessful and by the reward feelings of being successful. The use of opiates takes that system away. For years we have wondered how people have continued to use opiates when they lost their families, their money, their jobs, and their lives totally fell apart. While opiate-dependent patients realize that it is happening, the uncomfortable feelings associated with those consequences of their use are removed by the use of the opiate (guilt,shame). As long as the patient has the opiate, they do not feel any of the frustration or uncomfortable feelings associated with their life falling apart. What we do in treatment is to remove the opiate and ask the patient to begin to deal with their lives without it. The uncomfortable feelings created by all of the destruction that they have wrought within their life and in their relationships is often a motivating factor to them doing the uncomfortable tasks and learning the new behaviors that it takes to become abstinent from the drugs. The patients over time learn to use a support system and begin to learn new ways and behaviors to deal with difficult situations. The patient really only has two choices to deal with the uncomfortable feelings associated with their maladaptive way of behaving. They either have to go back to using the opiates to erase these feelings or they have to learn new behaviors to deal with them so that they become adaptive. In my observation of patients for over 25 years, this is probably one of the most difficult human endeavors that is ever accomplished. We would all be very happy if the patients could accomplish this change while they were on an opiate such as Buprenorphine to help them compensate for their maladaptive behavior while they were changing. The problem is that you cannot change while you are actually on the opiate because you have a lack of both positive and negative feedback from attempting to learn your new behaviors. This analogy can be applied to any human endeavor. Our observation was that the patients on Buprenorphine were unable to learn new adaptive behaviors and to use a support system. Eventually, the Buprenorphine, even at maximum doses, does not take away the uncomfortable feelings, and they went back to using the opiates they had previously. Secondarily, if Buprenorphine was tapered off, they went back to using the opiates the had been using previously. In the above cited study, 90% of patients in both Phase I and Phase II trials did this. The other thing of note in both the COMBINE Study and the Weiss Study cited above is that there was no difference in standard medical management from just seeing the doctor and adjunctive counseling by a trained counselor both in the Weiss study above for opiates and the COMBINE Study for alcohol. Those of us who have been in this field for a long period of time looked at the studies and scratched our heads wondering why the counseling did not have any impact as we see so many people who have benefited both from cognitive behavioral therapy, dialectical behavioral therapy, and rational emotive therapy. The reason of course is that if you are taking the opiate or relapsing on the opiate and\/or continuing to drink but just decreasing your heavy drinking days, then you are unable to use the suggestions that are given in any type of therapy. You may hear them and attempt them but you can never learn these adaptive behaviors if you have no emotional feedback from attempting and mastering the skills. Let me give you an example. We will use the recovery skills of learning "living one day at a time" or "live in the present." As I go into treatment, my mind is spinning around and anxious about what has happened in the past and what I have to do in the future. I'm taught to use prayer (reliance on a Higher Power), meditation (connection to a Higher Power), meetings, sponsor, and talking to deal with these feelings. I initially scoff at these modalities but find combinations that begin to relieve my uncomfortable emotions (anxiety). I will use what works for me and practice it and begin to get better at it. If I am on an opiate that blocks and dampens the uncomfortable emotions (frustration, anxiety, anger), I have no need for the above modalities. I get no emotional feedback from them. I will not learn new behaviors and skills. This is what I have always done. If things were getting really bad, I took more opiates. The problem is the emotional damping effect of the opiates wears off and I have to take more. The same will happen with Suboxone and I will go back to using. We have said in this field for over 40 years that you can get nothing out of therapy or treatment if you are using and I continue to believe this. The above example is simplistic but I believe it is the basis for change of behavior. It is at the core of how I change my belief system. It is at the core of how I change who and what I am. I've noted over the years that a lot of the patients go to support groups and say that it doesn't help. My observation is that they don't know how to use the support groups nor do they have the skills to use them. You must continue to try with adequate support and therapy "to learn to use a support system". Again, if you don't feel the positive or negative feedback, you will never make progress on the skill. Our observation in our studies was that the patients that were put on Buprenorphine did just as well or poorly whether they went through treatment or did not go through treatment. They were unable to change while on the Buprenorphine. This, of course, is not a 100% thing but I would put a positive outcome at less than 10% under the above conditions. I strongly feel that ASAM should have put the criteria for positive outcome as abstinence when citing this article as an evidence-based piece of research, which should motivate us to put more patients on Buprenorphine. Most of us in addiction medicine consider abstinence as a positive outcome for all the reasons cited above.