INTERVIEW
1-How did you come to study on cocaine addiction?
I was a Medical Director at a Methadone clinic in the Bronx for two years after completing my residency training in order to pay back a scholarship I had to receive to pay for medical school. This is how I became interested and eventually board certified in Addition Medicine. The concept of a therapeutic vaccine to treat cocaine addiction also married well with my graduate work in Immunology ( happened before I went to medical school)
2-Whose idea was it?
The genesis of the idea was with a company called Immunologic in 1996. Tom Kosten had a collaborative relationship with one of the principal scientist Barbara Fox who tested the concept in rats first.
3-What was the main purpose of this study?
This study is called a Phase IIb in drug development which is also sometimes called a “proof of concept” study. This mean you are trying to prove in a relatively small, select patient population that something has the effect that you are predicting (hypothesis testing). The purpose of this study in particular was to test the hypothesis that cocaine specific antibodies can attach to cocaine as is enters the blood stream and prevent a certain amount from entering the brain. If successful, then the person using cocaine will not have enough cocaine to enter the brain and cause the expected feeling one gets from using cocaine and they would be less likely to use again if they were really trying to stop (as opposed ot someone who is not motivated to stop)
4-What was your role and Dr Kosten’s in this study?
Dr. Kosten was the Principal Investigator (the guy who wrote the grant to fund the study and who has the experience to conduct clinical trials) and I was the sub-investigator in charge of managing the daily activities of the trial.
5-How could you explain the procedure of the research and the experimental parts?
Read the paper under Material and Methods
6-Did people volunteered for being tested?
All people who enter into clinical trials do so voluntarily and must sign an informed consent given their written permission for us to treat them within the context of the trail
7-Were they paid?
They got free medicine and medical care and a nominal fee for coming to clinic
8-Were they all addicted to cocaine?
Yes, as reported in DSM IV under Substance Dependence (you can Google the term)
9-How may of them were they?
115 entered the trial (were randomized) but only 14 got the vaccinations
10-Who was in charge of the study, who was supervising?
I was in charge and Tom was supervising. For any trial conducted in the US there is also a requirement for an Institutional Review Board to monitor the trial for ethical considerations and safety of subjects. Often a second and a separate Data Monitoring Review Board will also independently review the study at fixed intervals to make sure the study is being conducted properly
11-Who paid for it?
The National Institutes of Drug Abuse paid for the conduct (operations) of the study, the company Xenova (now Celtic) provided the drug, and I was paid by a grant I received called a VA Career Development Award
12-Do you think that you could use this same method for trying to beat other addictions from other drugs?
Yes, including nicotine
13-This question is less formal and comes directly from me;
Do you really think that this study is really relevant? Not that I disagree with all this, I am just wondering if you had ever thought that maybe people, after receiving the vaccine, would increase the quantity of drug they take to overpass the effect of the vaccine or simply switch to another drug, maybe more powerful, more violent and more dangerous?
There does exist the possibility that people will use more cocaine to overcome the effects of the vaccine and for certain drugs the effects can be potentially dangerous. That is why this treatment needs to be given in conjunction with a structured drug recovery program where people engage in other therapies known to help drug addiction (such as cognitive behavioural therapy).