Clinical trial begins for an experimental drug for opioid cravings

Clinical trial begins for an experimental drug for opioid cravings

The National Institutes of Health Clinical Center has begun a research on a drug developed to deal with the cravings linked with opioid use. The clinical trial would test the safety of the active compound in the drug, ANS-6637, in healthy individuals. It would also look at how the body processes the drug when administered with an additional drug metabolized by similar liver enzymes. The trial is being conducted with the help of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and funded by the NIH’s Helping to End Addiction Long-Term (HEAL) Initiative. This is an extensive program to fast-track the research endeavors to curtail the opioid epidemic, which has become a public health crisis.

Opioids play a critical role in pain management, however, they have a strong potential to be abused, as is evident by the current opioid crisis afflicting every region of the U.S. NIAID Director Anthony S. Fauci stated that multiple high-risk behaviors are linked to opioid misuse and addiction which might pave the way for direct or indirect infections with hepatitis C virus, human immunodeficiency viruses (HIV), other ailments, and even premature death. Since certain infectious diseases and substance use disorders (SUD) are often entangled, it is indispensable that the physicians dealing with infectious diseases recognize these and be prepared to attend to both the issues in order to provide holistic care to patients.

New drug trial looks promising

Opioid use causes a rush of dopamine, a chemical neurotransmitter in the brain associated with the reward system. With habitual use, the reward system of the brain gets rewired, apparently creating insatiable cravings for opioids. The brain also experiences cravings when they are in close contact with the accompanying cues like drug use partners and injecting paraphernalia. The experimental drug would target these cravings.

Currently, there are a only a couple of medicinal tools that work towards curbing the cravings experienced by patients suffering an OUD, said Henry Masur, principal investigator of the novel research. He further added that the new experiment would set the base for upcoming studies which may pave the way for the development of effective treatment modalities to deal with drug cravings.

The drug is being developed by Amygdala Neurosciences, Inc. The preclinical animal research has indicated that the dopamine surges get inhibited by the drug and apparently, these surges develop due to the use of opioid in people struggling with OUD. However, at the same time, it does not affect the standard amounts of dopamine that are required for the normal functioning of the brain.

Trial plan

The trial aims to enroll 50 adults in good health aged between 18 and 65 for the duration of the trial. The participants would reside at the clinical center for a period of 10 days. They would return to their homes and after a week, revisit the center for a concluding outpatient session.

During the trial, one dose of midazolam would be provided to the volunteers on the first day. Midazolam’s processing by the body is well established, therefore, for liver metabolism it acts as a standard or a template. None of the drugs will be administered on the second day. 600 milligrams of ANS -6637 would be received by the volunteers each day. The study subjects would then be provided with both ANS-6637 and midazolam together on the eighth day to evaluate the impact of investigational drug on the levels of midazolam. This will facilitate the researchers to understand the processing of ANS-6637 in the body which would help in designing the next level of research in participants struggling with OUD.

OUD is treatable

Dr. Sarah Kattakuzhy, an assistant investigator stated that it is possible to treat an opioid disorder, however, there is a dearth of scientific advancement in this area because of the associated stigma and believed misconceptions. Nevertheless, the initiation of this trial has made the assessment of an innovative prospective therapeutic for the management of OUD possible with the help of the NIAID and HEAL Initiative. If its effectiveness is proved, it could be the future of drug addiction treatment by being a part of an all-inclusive array of services comprising behavioral interventions, agonist therapy for opioid, and harm reduction.

If you or someone you know is addicted to opioids or any other drugs and is looking for drug abuse help to overcome their addiction, then get in touch with the California Drug Addiction Helpline. Our professionals can help you with all the information you require for drug rehab centers in California. You can either call our 24/7 drug addiction treatment helpline 855-980-1946 or chat online with a representative for further assistance.