May 09, 2004
A historic Congressional caucus built around the issue of addiction treatment and recovery is off to a strong start, with
38 members of the House of Representatives signed up and the group already holding briefings for lawmakers' staffers.
In 1999, the latest year I have statistics
for, 38,273 people died due to drugs and alcohol. this number does not include accidents, homicides, and other causes indirectly
related to drug and alcohol use. It also does not include newborn deaths due to mother's drug or alcohol use. The addition
of these deaths would make the number significantly higher. Excluding the indirect causes of drug and alcohol deaths, 14 of
every 100,000 people in the United States died from drug and alcohol induced deaths in 1999.
When people mix cocaine and alcohol consumption, they are compounding the danger each drug poses and unknowingly forming
a complex chemical experiment within their bodies. NIDA-funded researchers have found that the human liver combines cocaine
and alcohol and manufactures a third substance, cocaethylene, that intensifies cocaine's euphoric effects, while possibly
increasing the risk of sudden death.
PLEASE! IF YOU KNOW OF ANYONE THAT IS ADDICTED TO COCAINE, THEY ARE MORE
THAN LIKELY ABUSING ALCOHOL ALSO, PLEASE MAKE THEM AWARE OF THE DANGER OF MIXING COCAINE AND ALCOHOL. EACH ON IT'S OWN HAS
ENOUGH DANGERS, MAKE THEM AWARE OF THE ADDED DANGER OF COCAETHYLENE!
Xenova is developing a therapeutic vaccine, TA-CD, for the treatment of cocaine dependence, for which
there is no currently available effective treatment.
Current treatment programs for cocaine addiction consist primarily of counselling services and medication
to treat the symptoms of depression and anxiety associated with cocaine withdrawal. Currently, there is no medication that
addresses the strong cravings for cocaine that an addicted individual experiences. These cravings can last for long periods
of time following abstinence and frequently lead to recidivism. For those cocaine users in the US who seek treatment, the
overall retention rates in treatment programs are low; recidivism rates are typically greater than 50%. Currently, no
pharmacotherapies have been shown to be clinically effective and there is an urgent need for novel therapeutic approaches.
is designed to induce cocaine-specific antibodies which bind to cocaine in the blood, blocking its uptake into the brain.
Therefore, the human physiological response to cocaine is altered, reducing the reinforcing properties of cocaine and permitting
patients to break the cycle of addiction and abuse.
The active ingredient of the TA-CD vaccine is a protein conjugate:
a cocaine derivative coupled to recombinant
cholera toxin B (rCTB). The finished TA-CD vaccine consists of the protein
conjugate adsorbed onto aluminium hydroxide
gel adjuvant in saline. The vaccine is administered by intramuscular injection
and it is anticipated that a short
course of injections will be required to induce antibody responses.
In a preclinical
model of cocaine self-administration, immunisation with TA-CD vaccine reduced drug-seeking behaviour compared to that observed
in cocaine naïve rodents. Analysis of serum from immunised rodents showed the presence of cocaine-specific antibodies.
Two clinical studies have been conducted to assess the
safety and immunogenicity of TA-CD vaccine
to date. Up to 3 vaccinations (at 0, 4 and 8 weeks) of TA-CD 709 µg, 82 µg,
13 µg or TA-CD placebo were administered to
34 cocaine abstinent patients in a phase I study. In a phase IIa study,
up to 4 vaccinations (at 0, 2, 4 and 8 weeks)
of TA-CD 82 µg were administered im in 9 outpatient cocaine abusers. In both studies, TA-CD vaccine was well tolerated both
locally and systemically. There have not been any severe or moderate adverse events that have been considered related to the
vaccine. Antibody levels correlated both with the dose of vaccine given and with the number of vaccinations. Anti-cocaine
antibodies were detected subsequent to the second injection, levels peaked about 12 weeks after the initial injection and
declined at further time points until one year.
The antibody levels in the clinical trials approach those produced in the rodent self-administration model and have
appropriate specificity for cocaine. The highest level of
anti-cocaine IgG was detected after 4 vaccinations during
phase II clinical trial.
This Phase IIa clinical trial, supported by the US National Institute on Drug Abuse (NIDA), was completed and the successful
results of this trial were announced in July 2001. Attenuation of the usual euphoric effects of cocaine was reported amongst
patients who relapsed during the study, providing anecdotal evidence of the benefit TA-CD may provide.
The start of a Phase IIa cocaine administration trial was announced on 14 April 2003. The ten-patient open label trial
is being conducted in the United States and is designed to evaluate the effect of TA-CD on behavioural changes associated
with cocaine administration.
The results of a second Phase IIa dose escalation trial were reported on 17 June 2003. This study, which started in April
2002, was designed to evaluate the safety and immunogenicity of TA-CD using 4 or 5 dose vaccination schedules. The trial involved
the enrolment of 13 subjects, all of whom were cocaine abusers seeking help with their addiction at the start of the trial.
Patients were treated with up to five injections of the vaccine over a twelve week period using doses up to 360 µg each. Of
the thirteen enrolled, twelve subjects completed the 12 month evaluation period to assess safety, immune response and cocaine
As for the previous study, the results showed the vaccine to be safe and well tolerated with a dose-related immune response.
Of those 16 patients in the two Phase IIa studies who used cocaine at any time following vaccination, 14 reported a reduction
of the usual euphoric effect normally associated with cocaine use, providing further anecdotal evidence of the vaccine's proposed
mode of action.
On 24 October 2003, Xenova announced the start of the first randomised, placebo controlled Phase IIb clinical trial for
TA-CD. The primary objective of this new study is to determine the efficacy of TA-CD in addicts seeking treatment for cocaine
abuse, and to determine appropriate end-points for a Phase III study.
Up to 132 subjects, all of whom are methadone-dependent cocaine addicts being treated for drug dependency are being recruited
into this clinical study. Half the subjects will be treated with active TA-CD and half will be given a placebo. Subjects will
be monitored three times a week to assess cocaine usage, including testing for cocaine metabolites in urine, for a period
of 20 weeks. Patients will also undergo medical examinations and blood tests for anti-cocaine antibodies to assess the immunogenicity
of the dosing schedule. The trial is expected to last up to two years (depending upon the rate of recruitment) and will allow
an objective assessment of the efficacy of the TA-CD vaccine against placebo.
The TA-CD investigations are being funded in part by the National Institute on Drug Abuse (NIDA) which recognises cocaine
abuse to be a major problem in the U.S. NIDA has also supported earlier clinical work as part of this program.
Researchers were surprised to find how effective the drug baclofen, commonly used to treat spasticity, has been
in helping individuals overcome cocaine addictions, the Medical Post reported Jan. 6.
The results of a random, double-blind
study involving 70 people addicted to cocaine found that baclofen stops the release of dopamine in the brain. In doing so,
the drug reduces the "high" associated with cocaine use.
The drug is particularly effective for chronic, heavy users
of crack cocaine.
"I was surprised by the results of our study," said principal investigator Steve Shoptaw, Ph.D.,
a psychologist at the University of California Neuropsychiatric Institute.
The study's findings were so impressive
that researchers had an independent analysis of the research done by the Biostatistics Group at Stanford University Medical
In March, an eight-week clinical trial will begin in eight research centers throughout the U.S. Shoptaw said
if the trial supports the study's findings, "I think that would generate a great deal of excitement in addiction medicine."
The study is published in the Journal of Clinical Psychiatry.
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Summer can be a risky time for teens. More teens smoke marijuana for the first time in June and July than
in any other month. Don't let your teen's summer go to pot. Check out our new School's Out section on TheAntiDrug.com for great ways to keep your kids drug-free this summer.