Cincinnati researchers conducting clinical trial of cocaine vaccine

Sep 29, 2010

Researchers at the University of Cincinnati are conducting a clinical trial for a vaccine designed to treat cocaine addiction by preventing the drug from entering the brain, thus reducing its pleasurable effects.

Participants are being accepted for the study, a phase 2 clinical trial of the cocaine vaccine TA-CD (Therapy for Addiction-Cocaine Dependence). Phase 2 clinical trials are performed on larger groups after the initial safety of the study drug has been confirmed in phase 1 trials.

The study is being conducted at the Cincinnati Department of Veterans Affairs Medical Center in Corryville, but non-veterans are welcome to participate. The vaccine, whose patent is owned by the international private equity firm Celtic Pharma, is being provided to the VA Cooperative Studies Program via the National Institute on Drug Abuse, part of the National Institutes of Health.

Cocaine is a strong stimulant and is highly addictive. According to the 2008 National Survey on Drug Use and Health, about 1.9 million Americans had used cocaine within the past month.

Scientists began developing the cocaine vaccine in 1997 after an article in Nature Medicine by Barbara Fox, PhD, hypothesized that vaccinating cocaine-addicted individuals against cocaine would likely be an effective way of treating the disorder.

Eugene Somoza, MD, PhD, a professor in UC’s department of psychiatry and , says psychosocial treatment such as talk therapy is the current standard of care for cocaine-dependent patients.

"There are currently no Food and Drug Administration-approved therapies for ,” says Somoza, who also noted that the study is important because of its vaccine-based approach and because it is synergistic with other treatments being studied that involve interventions targeting structures within the brain.

The study will test the efficacy of the vaccine versus a placebo with healthy cocaine-dependent volunteers over a period of 18 weeks, with a total of 300 patients participating at six sites. The lead investigator is Thomas Kosten, MD, of Baylor College of Medicine in Houston. Somoza is the principal investigator at the Cincinnati site.

Somoza notes that traditional immunotherapy targets involve complex molecules considered foreign by the body’s , which develops specific antibodies against them. Cocaine is a simple molecule, and can only trigger the immune system by attaching to a complex molecule. When this happens, the immune system produces antibodies against it just as it does when viral or bacterial proteins enter the body.

As a result, when vaccinated patients use cocaine and its molecules reach the bloodstream, they are immediately sequestered by the antibodies—which hold on tightly to them, thus preventing them from entering the brain where they produce their deleterious effects.

"Addiction is dependent on how quickly the substance gets to the brain,” Somoza says. "So by slowing down or stopping the process, it would be possible to decrease the pleasurable effect individuals get from cocaine.”

Cocaine, as opposed to alcohol, opiates or benzodiazepines (such as Valium), does not usually produce severe withdrawal symptoms, according to Somoza. Thus, cocaine-dependent individuals are not compelled to take it every day and may choose to take it at convenient times, such as weekends.

This makes it significantly more difficult to determine whether or not addicted individuals have used cocaine on any given day, thus making the design of cocaine clinical trials more complicated than clinical trials on other addictive agents. For this reason, study participants will be required to come to the clinic three times a week. Participants may be compensated for time and travel.

Somoza’s research team, co-directed by Theresa Winhusen, PhD, is the Cincinnati Addiction Research Center (CinARC). It has been conducting clinical trials for the past 15 years in an effort to develop new pharmacological and psychosocial treatments for addiction, now recognized as chronic relapsing brain disorder.

Somoza reports no conflicts of interest with the current trial.

Explore further: FDA approves hard-to-abuse narcotic painkiller

add to favorites email to friend print save as pdf

Related Stories

Cocaine Vaccine Shows Promise for Treating Addiction

Oct 05, 2009

(PhysOrg.com) -- Immunization with an experimental anti-cocaine vaccine resulted in a substantial reduction in cocaine use in 38 percent of vaccinated patients in a clinical trial supported by the National Institute on Drug ...

Cocaine cravings are studied

Jun 15, 2006

U.S. scientists say they have found the brain chemistry that underlies "cue-induced" craving in cocaine addicts.

Drugs to treat cocaine abuse?

Aug 10, 2010

The authors of a new study in Biological Psychiatry explore pharmacological strategies for reducing cocaine self-administration in animals that may have implications for treating cocaine dependence in humans.

Tuning cocaine addiction

Jul 19, 2010

small bits of genetic material that influence gene expression - reduces the urge for a cocaine fix in mice, according to a paper published online on July 19 in the Journal of Experimental Medicine.

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

13 hours ago

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

14 hours ago

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

14 hours ago

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

14 hours ago

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments : 0