Focus Naltrexone
The Impact of Pharmacotherapy
on the Judicial System

By Thom Montgomery, Ph. D.
The Brookside Institute – 2003

Driving Under the Influence arrests, accidents, and fatalities represent an enormous issue for courts, probation departments, prosecutors and defense attorneys in California and nationwide.

While current judicial sentencing options have been improved, the need for more modern techniques in dealing with drug and alcohol offenders is becoming increasingly strident. Fortunately, science has made several breakthroughs in the last decade which promise hope for the legal system.

According to 1999 FBI Uniform Crime Reports, arrests for drug abuse violations have steadily increased since 1991. There were 11.56 million drug-related arrests in 1998 alone. Between 1984 and 1999, the number of defendants charged with a drug offense in Federal courts increased from 11,854 to 29,306. Sixty five percent of those charged during 1999 had previously been arrested; 28 percent had five prior arrests Half of those charged had previously been convicted; one third of them convicted of a felony. Sixteen percent of incarcerated drug offenders reported being an importer, grower or manufacturer of illicit drugs; 25 percent reported that they distributed drugs to street-level dealers. Children are increasingly involved with the most serious of drugs: Despite advances in the treatment of heroin dependence, 1.4 percent of the nation’s 10th grade students used heroin in 1998.

But perhaps the most common drug related crime in the United States is that of driving under the influence of alcohol and other drugs. 15,794 alcohol-related traffic fatalities occurred in 1999, 38.2 percent of all traffic-related fatalities. California led the way with one out of fifteen fatalities occurring in that State alone. Nationwide, this is a death every 33 minutes. States are hard pressed to find solutions to this epidemic problem.

Because of the inherent addiction implications of multiple DUI offenses, states have increased penalties and treatment/education options for multiple offenders. California laws are among the most stringent: for a first offense, the license is confiscated and the fines range from $390 to $1,000, with jail time a possibility. Subsequent convictions result in enhanced penalties. Second convictions result in a mandatory 18 month program to retrieve the license, with a third offense requiring a 30 month program. In comparison, Arizona requires that a person convicted of a second offense within five years of the first must serve not less than ninety days in jail, with suspension of all but thirty days of the sentence if the individual completes a court ordered alcohol screening, counseling, education and treatment program. The thirty days of mandated jail time must be served consecutively except in cases of work furlough programs . Missouri also has a five year period in which a second offense may occur, and raises the penalty from a Class C misdemeanor [first offense] to a Class D felony. The second offense requires 48 hours of incarceration at a minimum or 10 days community service. License suspension may result, and the license cannot be restored until the offender successfully completes a substance abuse traffic offender program.

The Supreme Court has upheld consideration of prior offenses, even though the defendant had not been made aware that an earlier conviction could result in enhancement in future cases.

Alaska has begun using Naltrexone as an approved option in the education and treatment of DUI offenders. By October of 2000, the Alaska DUI Prevention Task Force had identified Naltrexone as the alternative of choice, limited only by availability of physicians and the cost, and a successful court referral system had been established. California has been using Naltrexone and counseling in Butte County, and is turning now to a state-wide pilot project. Stewart B. Leavitt, Ph. D., states "Naltrexone was approved for alcoholism treatment by the Federal Food and Drug Administration [FDA] in December 1994. This new indication was authorized in part because of naltrexone’s safe use for more than 20 years in the treatment of opioid dependency and the results from two placebo-controlled studies demonstrating its usefulness in alcoholism. The only other medication with FDA approval for alcoholism was disulfiram…introduced in 1948. Whereas disulfiram can induce nausea, vomiting and other unpleasant reactions in those who drink alcohol while taking the medication, Naltrexone promises a gentler form of persuasion. It inhibits intense cravings for alcohol and diminishes its satisfying effects if any drinks are consumed while the person is taking Naltrexone..." Organic brain functions are critical to understanding both drug activity and recovery needs. Carlton K. Erickson, Ph. D., points out that there are essentially four Neurotransmitter outcomes within a synaptic interaction:

1. Attachment to an excitatory receptor site – more likely to fire.
2. Attachment to an inhibitory receptor site – less likely to fire.
3. "Gobbled up by a monster enzyme" – never to be heard from again.
4. Taken back up again [Re-uptake] into the vesicle – to be sent further down the nerve cell for use later on.

States Dr. Erickson, "The reuptake process is critical to understanding how certain drugs work [e. g. cocaine] to block the reuptake of dopamine, leaves more in the synapse, which leads to a cascade effect causing the characteristic 'high' that we are familiar with." It is generally agreed that the neurotransmitters of addiction in the mezolimbic system are:

1. Dopamine
2. Serotonin
3. Endorphins
4. GABA/Glutamate

Further, most current research is pointing to the medial forebrain bundle as the major site of action of addictive drugs. The medial forebrain bundle consists of the ventral tegmental area, the lateral hypothalamus, the nucleus acumbens, the frontal cortex and the amygdala. The involvement of the medial forebrain bundle is strong evidence that addiction is beyond the conscious control of the individual.

Technology today allows us to view the living, active brain as it functions, and this is having important implications for treatment. Brain SPECT [Single Photon Emission Computed Tomography] studies conducted by Dr. Daniel Amen in California reveal wide spread and devastating impact on the entire cortical surface, while recovery shows a restoration of much of the lost activity.

Yet much of modern treatment remains locked into the early methods outlined by Alcoholics Anonymous, which is behavior modification through use of a structured approach to individual dysfunction within a self-help group modality. So successful was A. A. in treating alcohol addiction, that several other addiction groups centered around drugs and behaviors of choice are based on the 12 step method A. A. employs. Medical science has been used mostly to complete physical detoxification. The psychiatric sciences have been utilized only to provide treatment for mental health phenomenon concurrent with, and often caused by, the addiction.

In 1948, it was recognized that the use of disulfiram [Antabuse] could assist patients in avoiding the decision to drink, providing a punitive result for those using alcohol with disulfiram in their system. Methadone, likewise, has been used for several decades to provide a safe, non-intoxicating replacement for heroin at low cost. Court systems, beginning in the 1960s and continuing through today, have often required those convicted of DUI offenses to utilize disulfiram, and those convicted of heroin related offenses to enter Methadone treatment programs. The results, while significantly better than non-treatment, have been mixed: Methadone requires ongoing administration. Antidepressants are used in many cases of high risk behaviors.

Treatment of addiction in the 21st Century is swiftly moving toward pharmacotherapeutic and neuropsychiatric approaches. The use of Naltrexone [ReVia] appears to be among the most promising approaches.

For most alcoholics and addicts, the persistence of cravings following successful detoxification has led to chronic relapse issues. The vital first few months of recovery are plagued by faltering and failure in too many instances. The effectiveness of behavior modification techniques, such as those employed by self-help groups and most treatment centers, which focus on changing elements of life style as a means of recovery enhancement, is greatly lessened by the necessary focus on craving reduction and ongoing habitual activities.

Approved by the FDA for use with alcoholics since 1995, and for use in treatment of opioid dependencies since the late 1980s, Naltrexone has, in study after study, proven the most effective drug yet to relieve the cravings associated with relapse. Early studies at Yale and the University of Pennsylvania by Dr. Joseph Volpicelli and others , have consistently shown the effectiveness of Naltrexone. Current studies show that Naltrexone may also be effective in treating other addictions, including behavioral addictions such as gambling.

Naltrexone, commercially distributed by E.I. du Pont de Nemours and Co. of Wilmington, Del., as Revia, regulates neural activity in a part of the brain where human cravings are processed. The fact that Naltrexone may work "across the board" tends to demonstrate that science has come closer than ever before to finding the single common physical denominator in the process of craving.

It is estimated that 40 percent to 70 percent of patients undergoing treatment for alcoholism will relapse within the first year . In the U. S. only two drugs are currently approved for the treatment of alcoholism: disulfiram and Naltrexone. Disulfiram inhibits the metabolism of anticoagulant drugs, phenytoin and isoniazid. Essentially, it acts as an aversive drug. States Kirchner, "One study of 605 alcohol dependent men found no difference in the rates of abstinence and time to a first drink at one year in the men who received 1 mg of disulfiram, 250 mg of disulfiram or a placebo. Despite the lack of proven efficacy, some patients and physicians believe the drug serves as a psychologic deterrent."

Compare this to the effects of Naltrexone. "The effectiveness of Naltrexone, an FDA–approved medication for alcohol dependence, can be improved if we support and help patients to consistently take their medication. We illustrate how patient noncompliance with treatment negatively affects outcome, and, we describe a new intervention to enhance medication compliance. Outcome was evaluated for 196 alcohol dependent outpatients who were treated with 50 mg/day Naltrexone or placebo for 12 weeks. For patients who adhered to the prescribed treatment, relapse rates were lower with Naltrexone than placebo (10 percent vs. 38.6 percent, p < 0.001). For noncompliant patients, relapse rates were high and comparable between Naltrexone– and placebo–treated patients (42.9 percent vs. 40 percent). In a second study of 100 alcohol dependent outpatients, we introduced an intervention that resulted in better medication compliance rates compared to a previous Naltrexone study of patients who did not receive the intervention (77.0 percent vs. 60.8 percent, p < 0.01). This provided some support for the use of an intervention that targets medication compliance when prescribing Naltrexone." Volpicelli and Kirchner in their quoted articles both agree that Naltrexone is most effective when combined with counseling.

But it is not only with Alcohol Dependence that Naltrexone is found to be effective. As indicated in a story filed by Melanie Axelrod of ABC News, research shows that the drug Naltrexone, which the Food and Drug Administration approved for alcoholism in 1995 and for drug addiction in 1985, was able to reduce gambling urges in almost 75 percent of the 20 people in the study. Those people who received a placebo only cut their gambling urges by 24 percent. Reports Ms. Axelrod: "My original hypothesis was that I should never delude myself to think that I have solved the gambling problem," said Dr. Suck Wong Kim, director of the impulse control disorder clinic at the University of Minnesota. "What I am trying to s ay is that we now have promising drug agent that may be working." Kim believes the drug can help people who gamble because it suppresses the "rush or high" they usually got from playing and winning.

always worked: In a recent study involving heroin, cocaine, amphetamines and cannabis, positive results were found in using Naltrexone therapy combined with counseling and spiritual approaches. Three groups were involved in the study: Those using implants, those using a pill form and a group treated one year prior: "Urine drug screen results were obtained on 98 percent, 70 percent and 67 percent of the three groups respectively. A mean of 20 percent and 47 percent were positive for amphetamines and cannabis respectively. The rates of heroin positive urine tests were 3 percent, 5 percent, and 24 percent in the implant, tablet and historical groups respectively. The crude opiate free success rates were 84 percent, 67 percent and 50 percent in the implant, tablet and historical groups respectively. The overall calculated 12 month opiate free success rate was 60 percent. Use of the implants raised this from 54 percent to 84 percent. (P = 0.001)... The technology should be extended to the other addictive chemical cocaine, the THC of cannabis, amphetamine, and nicotine..."

This study also showed the importance of adjunctive support: "Multiple regression of all the tablet patient data shows that the most important variables in order of statistical significance were: numbers of detox treatments, work after treatment, spiritual belief, social support and cannabis use. Other factors were non-significant. When one considers the implant patients alone, no factors achieved the statistical level of significance, because simply having the implant was so much the predominant determinant of success. When all patients were considered as a group, the number of detoxes, social support, strength of spiritual belief, work after treatment, work before treatment, cannabis use and sporting involvement afterwards, all achieved statistical significance."

In California, so effective has Naltrexone been that it is the only drug, other than Methadone, specifically approved for payment by Medi-Cal as a form of therapy. This has increasing relevance to the judicial system in the State, already evidenced by the DUI treatment studies.

As Alaska and California have learned, recidivism rates are dramatically affected by Naltrexone treatment. A report filed by Honorable Darrell Stevens, Judge of the Butte County [California] Superior Court, Helen Harberts, Chief Probation Officer, Jane E. Pfeifer, Drug Court Program Manager, Superior Court and Ian Redmond, Research Assistant demonstrates the results.

In California, the presumptive level for driving under the influence [DUI] is .08. State law mandates jail sentences for DUI cases, with increased penalties for prior convictions. Though only one judge in Butte County participated in the initial project, the report filed by Judge Stevens shows the project’s success : “Arrests in Butte County for driving under the influence and alcohol related fatalities have been unacceptably high. During 1996-1997, 25 people died in DUI cases... There is an increased awareness regarding the issue of alcohol abuse and driving. However, there remains a core group of addicted drivers who continue to pose grave danger to the public, and occupy a significant portion of the community resources through health care, emergency services, police, court, jail and probation criminal justice costs. For these offenders, Butte County... created the ReVia Project... "Butte County studied participants for an average of 29 weeks of ingestion and an average of 10 months since completion. Some offenders have now been tracked for almost two years..."

The results were striking. Defendants given an Antabuse [disulfiram] option re-offended within one month of completion and 75 percent of the new offenses were alcohol/drug related. For the ReVia [Naltrexone] participants, re-offenses did not occur until 11 months after completion, and only 25 percent involved alcohol/drugs. Additionally, results closely resembled Drug Court results in many cases, with the defendants showing stable employment and better health. While the Drug Court had a recidivism rate between 10-11 percent, it is believed by the Project coordinators that with modifications, the Naltrexone approach will equal or exceed that of the Drug Court. Among the modifications needed would be a stronger emphasis on Cognitive Behavioral Therapy [CBT] approaches in the DUI course structure. CBT has the advantage of fitting in with the reality based approaches used in Drug Court, without the emphasis on past activities which tends to be the focus of other traditional treatment modalities.

There is no doubt that all social systems are impacted by drug dependence and abuse. Given the current budgetary restraints and political ambiguity regarding parity in health coverages for treatment, there is also little doubt that society lacks the will necessary to move treatment into the 21st Century. Fortunately, costs of Naltrexone treatment are minimal, especially considering the high costs of DUI offenses, and individuals can afford to participate with or without health care assistance in most cases.

While a nationwide study is obviously indicated, it is suggested that each State should begin projects similar to that in Butte County. The high cost in lives and property of failing to act immediately is evident. Costs to the State of such studies in DUI cases is minimal, since participants must pay for their own treatment and education under traditional sentencing guidelines. The efficacy of the approach is undoubted, and only the effect locally on recidivism would need to be computed.