Dr. Ihsan Salloum, M.D., M.P.H is the Chief of the Division of Alcohol and Substance Abuse at the University of Miami’s Department of Psychiatry and Behavioral Sciences. Under his department, the current study on Alcohol Use Disorder utilizes treatments with an extended release formulation of gabapentin enacarbil, a prodrug application of gabapentin.
Gabapentin itself is classified as an anticonvulsant drug, but it has other uses such as in moderate to severe primary restless leg syndrome and alleviating some forms of pain. This trial is intended test whether or not it can be applied to alleviate symptoms of alcohol dependence or to decrease alcohol consumption.
While this study is intended to aid those under the influence of alcohol addiction, alcoholism itself is an under-addressed condition in the medical field, due to its relationship with standard addictive behaviors. Related disorders, such as Alcohol use disorder, affect 16.6 million adults in the United States alone, and cost upwards of $223.5 billion in lost employment time, health care, and property damage as a direct result of alcohol abuse.
Following a brief assessment period, the study’s eligible participants will spend six months in random assignment to two treatment arms: One receiving the study medication, while the other receives a placebo. This double blind test includes both the team and the recipients not knowing who is taking the drug: The pills are intentionally similar looking to preserve the results of the test.
Participants will have a face-to-face visit every two weeks, with brief telephone calls with study staff in between these sessions. Self-administered computer-based counseling will also be available during the face- to-face visit, meant to educate the participant on the consumption of alcohol and the benefits of decreasing its use.
The intended results are to see if the medication helps people quit or decrease drinking alcohol. If this study is successful in showing these outcomes, then it would a great help to people in starting their recovery.
Dr. Salloum admits that he is not sure that their tests will result in a drug that conclusively ends alcohol .dependence in people, but that he hopes that gabapentin enacarbil would be a viable means to treat the symptoms.
“A medication that helps people significantly decrease or quit drinking would be really important to get people on the recovery path. So until we completely understand how this change happens in the brain and find treatment to reverse it, it is difficult to say that a drug has completely removed dependence”- Dr. Salloum.
According to previous studies, alcohol dependence and other addictions change how the brain works, often restarting addictions after a relapse. As such, trials like this one under Dr. Salloum would help determine the exact mechanisms of helpful drugs and how they would affect the underlying brain changes that were caused by alcoholism or other drug abuse.
This comprehensive work within the field of alcohol dependence and abuse will benefit companies who are trying to curb symptoms and help those with the disorder, hopefully benefitting the lives of those who suffer from it.
For more information on related clinical trials, or to see if you are eligible to participate in a study: Call (305)-243-7086. This study is open to both men and women 21 years of age or older who experience problems related to alcohol. No insurance is required, participation is confidential, and time will be compensated.