Fall is here. In some places, there is a slight chill in the air. The NFL season has started and college football rivalries are alive. Change is in the air. This month's mystery drug represents a change as well: a change in the course for the treatment of pain. When compared to other traditional analgesics, this month's drug is relatively new. This short description, vague as it may seem, contains major clues as to the drug's identity. Venture a guess?

This month's drug poses a threat as an abused substance. In fact, as a result of the escalating pain management movement, this drug has become a therapeutic mainstay for patients and their physicians. The drug is a narcotic; however, it is not a controlled substance. In its role as an analgesic it boasts some unique pharmacological properties. This month's drug is what is called a "pro drug." Once absorbed into the blood stream, it is converted into a more powerful secondary compound that binds with mu opiate receptors. As a mu receptor agonist, the drug delivers reliable analgesia for mild to moderate pain. A chemical cousin to this month's mystery drug has been discussed in prior Journal editions. Tapentadol (Nucynta) is a synthetic opiate that was designed off of the chemical features associated with this month's drug. Nucynta is a common component of opiate-based pain management therapies.

This month's drug is a synthetic substance; it is not an alkaloid of opium (codeine, morphine). Neither is it a representative of the semi-synthetic breed of opiates (hydrocodone, oxycodone). This drug is in a league of its own. First brought to market by Grunenthal GmbH in the late 1970s, Johnson and Johnson purchased the license and brought the product to the market in several different iterations. At present, the drug is produced in brand and generic formats. The extended-release form of the drug is arguably the most popular arrangement. There is no over-the-counter version of this drug.

Apart from the actions that the drug and its metabolite exert at the mu opiate receptor, the drug influences the release of serotonin, a monoamine neurotransmitter that, among other things, helps regulate mood. Further, the drug blocks the reuptake of norepinehprine, a neurotransmitter that regulates stimulative messages in the central nervous system, a process sometimes referred to as the "fight or flight" response. So as compared to other narcotic-based analgesics, this month's drug is more complex, and perhaps more utilitarian. A variety of experts and chemical researchers have ventured any number of off-label applications for this drug. Considering its activity vis-à-vis serotonin and epinephrine, the drug has been proposed as a treatment for depression and for anxiety. But to date there has been no official nod from the FDA to approve the drug for any purpose other than pain relief.

With the unique chemistry described above, many experts were of the opinion that this month's drug did not possess the same potential for abuse (dependency and addiction) posed by other narcotic analgesics. It was frequently averred to be a "safe" narcotic, a drug that could be used in a wide array of situations and applications over extended periods of time. Experience has turned out to paint a different picture. Patients who are prescribed this drug must be careful when the drug is taken for extended periods of time. Patients who take this drug as a regular component of a pain management strategy should not suddenly stop taking the drug. Like all agonists of the mu opiate receptor, prolonged administration can lead to tolerance and, ultimately, a dependency. Patients in those situations must follow a titration plan, a step-down plan to slowly wean off this drug. If this is not done, patients will experience a fairly typical opiate withdrawal syndrome. Despite the ominous warnings of dependency and tolerance (the need to take ever increasing amounts of a drug in order to achieve the same effect), the drug is well-tolerated by most patients. The drug does not trigger classic narcotic analgesic effects seen with drugs such as hydrocodone, oxycodone, and fentanyl. A patient taking an average clinical dose of the drug would be difficult to pick out of a crowd; it is quite unlikely that someone taking this drug would exhibit the classic on-the-nod symptoms that drug evaluators quickly pick up on when evaluating an opiate abuser. That is not to say that someone dedicated to getting stoned on this month's drug can't do it. It will just take more of it, perhaps a lot more of it.

On the street, this month's drug is sometimes found packaged with sedative drugs, such as Soma (carisoprodol) and Xanax (alprazolam). These mixtures comprise a drug cocktail that mixes opiate and central nervous system depressant effects. A sizeable Internet market exists for this drug as many online pharmacies sell it. In the changing world in which we live, the future for this drug is bright.

Click here for the drug of the month 

The Drug Enforcement Administration (DEA) has signaled its intent to regulate several widely used designer drugs to Schedule I of the Controlled Substances Act. The action may take place as soon as October 11. The move by the DEA will make it illegal to import, manufacture, sell, or possess a class of drugs called cathinones. Specifically, 4-methyl-N-methylcathinone (mephedrone), 3,4-methylenedioxymethylcathinone (methylone) and methylenedioxypyrovalerone (MDPV) are the subjects of this action. This move by the DEA is only a temporary regulation of these drugs under provisions of 21 U.S.C. 811(h). The temporary ban will stay in place for 12 months. A permanent ban may or may not follow this action by the DEA administrator, although conventional wisdom suggests future action by DEA and or the United States Congress.

The drugs referenced in this ban are members of a fast growing collection of substances known loosely as designer drugs. Mephedrone, methylone, and MDPV constitute a subclass of designer drugs known as "bath salts." The substances are sold as powders in small packages with product names like Ivory Wave, Vanilla Sky, and Bliss. Putatively, marked "not for human consumption," these products are snorted or injected by users. The high generated by their use has been described as a cross between "ecstasy," cocaine, and methamphetamine. The cathinone class of drugs is quite similar in effect to the high associated with methamphetamine use. By manipulating the molecular structure of the parent cathinone compound, drug manufactures create one-off "designer drugs" that often skirt state and federal laws. To date, 30 states have moved to independently ban these substances. But the vast reach of the Internet has made it difficult to control the sale and consumption of the drugs. Calls to poison control lines and hospital emergency rooms make it clear that the use of these substances has not abated.

Earlier this year, the DEA took similar action in an effort to control the distribution of synthetic cannabinoid compounds called Spice, or K2. Since that time, Spice products remain available on the Internet and in "head shops." Purveyors of Spice believe they operate outside the DEA restrictions because they utilize a substance not specifically referenced in the regulating statute. Federal and state law enforcement authorities argue that analog provisions of the statutes ban derivatives and look-alike drugs that are slight modifications of the original molecule. To date, few arrests and prosecutions have been pursued. Law enforcement has been flummoxed by the emergence of these drugs. The public has been equally confused as to what these drugs are and what should be done with them. The reality is that both the "bath salts" and Spice drugs are dangerous drugs, substances capable of causing dependency and addiction.

The three drugs that are the subjects of this ban have similar effects on users. The effects consist of, but are not limited to, the following:

• Dilated pupils, slow in the response to direct light
• Smooth pursuit
• Non-convergence NOT present
• Elevated pulse
• Fast internal clock (Romberg)
• Increased blood pressure
• Increased body temperature
• Dry mouth
• Warm skin; perspiration
• Rapid, repetitive speech patterns
• Meaningless repetitive movements

There are laboratory-based drug testing assays that can detect the use of bath salts, synthetic cannabinoids, and other esoteric substances that make up the modern genre of designer drugs. It is likely that this phenomenon of designer chemistry will continue into the future and that we will confront newer more nefarious substances that will first emerge in the marketplace as some innocuous product or another. And of course the packaging will be boldly marked, "NOT FOR HUMAN CONSUMPTION".

The MEDTOX Drug Abuse Recognition System (DARS) Program will soon offer a series of webinars devoted to identification and analysis of the designer drug phenomenon. Interested readers should contact the MEDTOX Journal for information and proposed schedules for this new and enlightening (DARS) training program.

MEDTOX is sole licensee of DARS the Drug Abuse Recognition System. MEDTOX provides sophisticated DARS instruction to clients who utilize forensic MEDTOX diagnostic and/or laboratory services. DARS is taught by master DAR instructors and by Drug Recognition Experts (DRE) who are specially trained to teach the sophisticated curriculum.

For some time now, clinical randomized trials in the United States have established the efficacy of sober voucher payments to patients who participate in the Community Reinforcement Approach (CRA) for the treatment of cocaine addiction. Traditionally, in these programs, patients who participate in scripted treatment and recovery programs are paid for each urine drug test that produces a negative test result. A component of a contingency management strategy, payments to patients for negative drug tests, has a history in America. In a recently published study, the strategy was replicated in Spain, a country that has a similar cocaine problem to the United States[1]. As in the United States, this tactical clinical approach seems to work. In the Spanish research model, the contingency management procedure of compensation for negative drug test results was coupled with a comprehensive CRA that included the following components: drug avoidance skills, lifestyle change, relationship counseling, other substance abuse counseling, and assessment of other possible psychiatric problems. The CRA protocol was applied in group-based sessions of 10-12 people for 90 minutes two times a week. If necessary, a weekly individual session was also used.

In this study, participants were assigned to treatment groups that included CRA therapy alone or CRA therapy and voucher payments bundled together. Participants were compensated for drug tests that produced negative results for benzoylecgonine, the primary metabolite of cocaine. The payment scale was calibrated in points. The points then converted to $0.35 increments of compensation. The first cocaine-negative specimen earned 10 points, with a five-point increase for each subsequent and consecutive cocaine-negative sample. Further, for each three consecutive cocaine negative specimens, patients earned a 40-point bonus. For the first 12 weeks of the program, the maximum possible compensation earned was approximately $1,438.20 (U.S.). For the CRA plus voucher group, the mean income was roughly $747.25 (U.S.).

Participants were allowed to exchange earned points for vouchers that allowed them to acquire a variety of goods and/or services that were considered to be compatible with a drug-free lifestyle. Therapists had the ultimate authority to approve or deny selected incentive purchases. Each purchase had to be compatible and in accordance with individual treatment goals.

Researchers compared the performances of participants who were randomly assigned to groups that received CRA alone or CRA plus vouchers. Although there were no statistically significant differences between the two treatment conditions in terms of retention in treatment, there was an overall trend for the CRA plus vouchers (bundled) group to have better rates in all retention measures. The incentivized group performed significantly better in terms of their overall rate of cocaine abstinence though. Over the course of a six-month period of study, CRA plus voucher participants faired 10% and 20% better in terms of their production of cocaine-negative test results. The results were more noticeable in months one though three; the performance results narrowed noticeably in months three through six however. A performance gap opened after month six where the CRA plus voucher cohort scored significantly better on psychiatric scale of the Addiction Severity Index (ASI). In terms of performance on various psychological and social competency scales, the results favored the CRA plus voucher cohort as well.

These results replicated and extend the results of studies carried out in the United States. They also corroborate the validity of this treatment model where financial incentives are used as a reward for positive steps taken towards recovery from substance abuse. What remains to be seen is how the success of this program may be transferable and applicable to patients being treated for substance abuse disorders in other treatment settings, i.e. opiate, alcohol, and amphetamine. And of course, dwindling public treatment funds can make the strategy difficult to pursue.

A significant number of our DAR Journal subscribers are employed by organizations that utilize and incorporate religious and spiritual beliefs into the substance abuse programs that serve their clients. From the Salvation Army's Adult Rehabilitation Center system to Alcoholic's Anonymous, faith and religious belief plays a significant roll in contemporary drug and alcohol treatment programs. In a recent study published in the Journal on Studies on Alcohol and Drugs, a cohort of 364 individuals with a mean age of 44 were evaluated for their patterns of alcohol consumption following changes in their spirituality and religiousness (SR)[1]. Participants in this study came from a number of settings, some were already in active treatment programs, others were not. 93 untreated alcoholics were recruited from the street. Six months of participant SR activity was correlated with their alcohol use at nine months. The SR practices included prayer, meditation, and scripture reading, as well as forgiveness of self, development of sense of meaning, and daily spiritual experiences.

Researchers found that learning to forgive oneself, to pray and to stop seeing oneself as punished by God predicted decreased drinking and fewer occasions of heavy drinking when drinking did occur. Adjusting for cofactors such as involvement in AA and baseline alcohol use, improvement at nine months spanned nearly every measurement of drinking. For those who did drink, SR impacted the numbers and frequency of heavy drinking days. The effects of SR were seen in participants who were not even in an AA program; AA of courses emphasizes spirituality in nearly all aspects of its dogma.

Sometimes public officials shy away from cooperation with drug and alcohol treatment programs that emphasize spirituality and religion as part of a recovery strategy. This study suggests that where and when appropriate, it is worth the time to encourage and direct clients to programs where religious practices and spirituality are incorporated into the whole body and soul approach to recovery. Talk to a drug court judge who has been sitting on the bench for awhile. The judge will tell you that spirituality or a spiritual awakening on the part of a drug court client is arguably the most common thread in a successful rehabilitation and the resumption of a sober lifestyle. 

Thank you subscribers. We appreciate your dedicated readership. At MEDTOX we are committed to providing clients with the service and solutions you need to run successful drug testing programs. Our Journal is just one way that we show that commitment. We always encourage feedback from our Journal. Please send your thoughts to medtoxjournal@medtox.com.