Use of illicit drugs and abuse of licit counterparts are associated with multiple physical health, emotional, and interpersonal problems. Cardiovascular disease, stroke, cancer, HIV/AIDS, anxiety, depression, and sleep problems, financial difficulties and legal complications, work, and family problems can all result from or be exacerbated by drug abuse. In 2013, 21.6 million Americans were dependent on drugs or were drug abusers, representing 8.2% of our population aged 12 and over. While most had problems with only alcohol, 2.6 million has problems with illicit drugs and alcohol, and 4.3 million with illicit drug alone. Marijuana is the primary illicit drug with 4.2 million abusers or dependents, followed by pain relievers (1.9 million), cocaine (855,000) and heroin (517,000). Unfortunately, of the 21.6 million Americans who need substance use treatment, 20.2 million of them did not receive it. Furthermore, in the U.S. each year drug abuse and drug addiction cost employers over $122 billion in lost productivity time and another $15 billion in health insurance costs. Routine screening for substance use disorders could alter this statistic and get more people the help they need. Indeed, since the inception of medication-assisted treatment (MAT) for opioid addiction, drug testing has provided both an objective measure of treatment efficacy and a tool to monitor patient progress. Likewise, increasing emphasis on treatment outcomes as evidence of program effectiveness has added significance to drug tests in Treatment Programs (TPs), as well as use of drug test results in response to quality assurance requirements. Up to this juncture, drug testing in treatment settings has been limited to either remote drug testing via laboratory-confined procedures that take a long time to return results, or on-site urine testing strips that have limited multiplexing and semi-quantitative measurement capacities. There is, thus, a compelling need for an advanced point of care drug testing solution to be implemented within addiction treatment settings. Drug test results help policymakers and TP administrators detect and monitor emerging trends in substance abuse that may signal a need to redirect resources. Drug use patterns have changed markedly in recent decades; for example, benzodiazepines, amphetamines, methamphetamine, and cocaine have increased in popularity while barbiturate use has diminished. New substances of abuse or combinations of substances and methods of ingestion present new treatment challenges and funding concerns. Through this SBIR Phase I activity SensoDx will develop a microfluidics point-of-care diagnostic cartridge that, in conjunction with a miniaturized analyzer instrumentation, will permit real-time screening of cocaine and methadone drug users in treatment facilities.
The aims of this project are to (1) Develop a triplex assay targeting simultaneous quantitative determination of buprenorphine, cocaine and morphine in saliva; (2) Analytically validate micro-assays for the three drugs in newly fashioned plastic ensemble cartridges; and (3) Establish the clinical utility of the new assay in a treatment program.
By developing next-generation tools for onsite monitoring and treatment of drugs of abuse, this project will help millions of addicted Americans receive help for their illness, as well as save employers some of the $122 billion in lost productivity time and $15 billion in health insurance costs.
