The End of My Addiction

likely to occur above 100 milligrams, with no limiting side effects, and in spite of the evidence from animal trials and my own case.
    Be that as it may, 120 milligrams was a major step in the right direction, and I hoped that the study would be the first in which patients achieved suppression of addiction. Dr. Bucknam’s patient Mr. A. had experienced that result with less baclofen than I had needed, and the animal trials of baclofen for alcohol, cocaine, heroin, methamphetamine, and nicotine addiction all showed that the medication had beneficial effects over a range of doses.
    I also drafted documents needed to submit the study proposal to France’s Programme Hospitalier de Recherche Clinique (PHRC), the Hospital Program for Clinical Research. Among the most important of these was a section on the safety record of high-dose baclofen, which furnished the basis for the informed consent form that alcohol-dependent patients would sign to participate in the trial. The statisticians on the preliminary team assembled by Professors X. and Y. said that we needed at least 250 patients, 125 in each group, to achieve statistically significant results.
     
    A couple of months later, Giancarlo Colombo wrote to suggest that we meet when he came to Paris in April for a two-day conference of the European Society for Biomedical Research on Alcoholism (ESBRA).
    When I wrote Giancarlo that I looked forward to meeting him, but that I was not a member of ESBRA and did not know about the conference, he immediately offered to sponsor me as a new member of the society. Giancarlo wrote one of the two required letters of recommendation, and his wife and colleague, Roberta Agabio, wrote the other.
    In the meantime I had sent my self-case report to Dr. Eliot L. Gardner, an expert on brain reward mechanisms in addiction, the director of the Laboratory of Behavioral Neuropharmacology at Albert Einstein College of Medicine of Yeshiva University in New York, and chief of the neuropsychopharmacology section of the Intramural Research Program of the National Institute on Drug Abuse (NIDA) of the U.S. National Institutes of Health. In early March Dr. Gardner e-mailed me:
    …I applaud your work and wish you much success with your large multicenter trial of high-dose baclofen…
    And also let me say that I completely agree with you on the topic of craving suppression…You are on the right track. Please do not let small-witted people derail you.
    And I also completely share your skepticism about naltrexone, acamprosate, topiramate, low-dose baclofen, and rimonabant [as anti-craving agents]…
    This was a great vote of confidence for the prospective PHRC study, and I happily shared it with Professors X. and Y. I then flew to New York City for the first time since I left in June 1999, my life and career as a cardiologist ruined by alcoholism. I was there to attend the seventy-fourth birthday party of my dear friend Arif Mardin, who was then seriously ill and who sadly died that summer, on the same day as my birthday. Walking the streets of Manhattan for the first time in seven years, I was flooded with bittersweet memories of past friends and experiences. It was emotionally wrenching to confront all that I had lost, but thanks to baclofen I was able to appreciate what I had gained as a person in my struggle against alcoholism and in my recovery.
    It was exhilarating to be back in a city I loved so much. It felt like home. At the same time there was a different quality from the emotional excitement I was prone to before baclofen. Instead of the sense that I was in danger of being carried away by my emotions, I felt grounded and calm. After a few days, I returned to Paris, troubled by the state of Arif’s health, but glad to have seen him and eager to bring the high-dose baclofen study to fruition.
    The final study proposal had to be submitted to PHRC very soon.
    The day before the deadline, Professors X. and Y. informed me that they had just decided to cancel the study as planned, and that their decision was final. They were no longer going to test high-dose baclofen, but instead a combination of high-dose baclofen and naltrexone versus naltrexone alone.
    I was floored. This would not enable the study to say anything definitive about the value of high-dose baclofen. Another problem was that “baclotrexone,” as I dubbed it, would in effect constitute a new medication with no known safety profile.
    Overnight, the only randomized trial of high-dose