Chooper's Guide ... the Internet's most comprehensive substance abuse treatment, prevention and intervention resource directory.

Morality Trumps Morbidity and Mortality or Follow The Money



Attachment Files

PDF |

Summary/Abstract

Drug Law policy continues its commitment to the drug war in 2014 despite the hyperbole in Washington.

Content

The Drug War will go down in history as one of the most ill conceived, inhumane and costly blunders in modern history and maybe, by some, classified as systematic genocide. Conceived in the Nixon Administration by an uneducated, ill informed and psychologically challenged President, the Drug War was the political answer to the epidemic created by a clandestine partnership between the CIA and the South Vietnamese army that funded covert operations in Cambodia with the proceeds of China White aka No. 4 heroin manufactured in southeast asia and exported to the US. Heroin addiction had historically been restricted primarily to poor inner city neighborhoods and the bohemian subculture. In 1969, Nixon launched Operation Intercept virtually closing down the border to reduce the supply of Marijuana entering the US which resulted in increased availability of other illicit substances. This was not a gateway drug issue but rather a function of availability. As incidence and prevalence of use of other “hard” substances spread to white middle America, drug use rapidly became a political and economic problem that required a dramatic solution to appease political constituencies at national and local levels. It was no longer an inner city black or Latino kid who was discovered dead in a bathroom stall with a needle hanging out of his arm but the golden boy who was the son of a prominent family who had been destined to become, by societal standards,  a prominent and productive asset in  mainstream society. Drugs had invaded white America and The Drug War was born and, along with it, a new free market, both black and corporate, emerged to feast on the carnage of broken lives. Carefully crafted media campaigns planted overt and subliminal messages in the consciousness of the moral majority depicting addiction as an incurable deviant behavior characterized by moral weakness and criminal behavior. Addiction was demonized and addicts became the lepers of biblical times, cast out to prison cells to rot leaving broken families and setting the stage for the next generation. A bleak scenario. A thinking person might ask, why do we as a society, allegedly civilized and attuned to human rights, continue to defend this policy and expend the economic and criminal justice resources that either directly or indirectly impacts over forty million Americans either in need of treatment or in recovery. How many trillions of dollars do we need to spend, how many people suffering from a disease do we need to incarcerate and how many people need to die before we as a nation can admit we were wrong. We have been creating and enforcing policies and laws based upon outdated information.

Alcoholism was first recognized as a disease in Sweden in 1848, the American Medical Association declared it a disease in 195x and finally The American Society of Addiction Medicine declared addiction a brain disease in  2011 and provided a comprehensive definition of the disease addressing the requisite elements of diagnosis, prognosis and treatment. This declaration was derived from new knowledge in neuroscience and genetics confirmed by empirical biological data illustrating the structural changes that occur in the brain of an addicted person.

Today I  shudder to think that corporate greed and political agendas have successfully and will continue to obscure the reality of addiction and dictate treatment policy in America. The drug war is not the black market nor the widespread availability of illicit substances but the misunderstanding by the American public of what is addiction. Research indicates that addiction and substance use are predominantly a result of environment and  genetics although there are three additional risk factors. The focus in this article is the impact of environment on substance use.

There is a direct correlation with the prevalence of substance use and poverty and the persistent pain of chronic hopelessness. The simple fact is that people will escape from pain and hopelessness by whatever means are available whether it be drugs, alcohol, food, sex or gambling. It is human nature and we are  hardwired in our midbrain area to avoid pain. No one willingly submits to acute chronic psychological, spiritual or physical pain. A well known study done by Lee Robins on the incidence of heroin use/addiction of returning Vietnam Vets found that only 5% relapsed within 10 months and only 12% relapsed briefly within three years. One might conclude then that a certain number of addicts can be categorized as chronic and they should receive the same level of health care services as any person suffering from a chronic disease and that these services should be dictated by efficacy and outcomes rather than morality or intervening economic interests.

The critical issue is reframing the epidemic of substance use and solving for the origin not the symptoms. To observe analogously,  American society has a compromised immune system. Our informal social institutions are diseased, poverty is rampant, our elementary educational system is approaching third world standards and our sense of accountability has been replaced by apathy. This is the war. New legislation must be passed commensurate with medical and scientific data and policies implemented to address addiction, its etiology and treatment, as both an individual and societal issue. The behaviors are symptomatic. As Sun Zu stated over 1500 years ago, one must adjust ones tactics according to the terrain. The terrain has changed.

I have included a study below that many will find controversial. It addresses the issue of morality and its impact, often fatal, on treatment. This study clearly indicates that there are better treatment options for the chronic opioid addict, in this case heroin, and yet surprisingly it has received little press as it is not politically correct and is certainly contentious even within the addiction treatment community. I ask the reader, why not replicate the study in the US and evaluate the evidence objectively. The objective is to save lives and reduce the societal impact of addiction not to pacify the moral majority or further political and economic interests. 

I have also provided below a table illustrating Federal Drug Control Spending by Function for the years 2012 - 2014 (budget) which clearly illustrates that although the government claims to now recognize substance use as a health problem the reality is that the emphasis remains on drug law enforcement and interdiction. The Drug War lives on.

 

View of NCT00175357 on 2013_01_17

ClinicalTrials Identifier:

NCT00175357

Updated:

2013_01_17

Descriptive Information

Brief title

NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction

Official title

North American Opiate Medication Initiative (NAOMI): Multi-Centre, Randomized Controlled Trial of Heroin-Assisted Therapy for Treatment-Refractory Injection Opiate Users

Brief summary

 

The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.

Detailed description

 

This is a two-centre (Vancouver, Montreal) RCT involving a total of 235 volunteers.  Eligible participants will be randomized to injectable heroin combined with oral methadone as desired (45%) versus oral methadone alone (45%). A subset of 10% will be randomized to injectable hydromorphone (Dilaudid™).  Hydromorphone and heroin will be given in a double-blind fashion; the purpose is to permit validation of reported illicit use of heroin through urine testing in the hydromorphone group.  Research visits will be conducted quarterly and will occur independently of treatment clinic visits.  Incentives will be used to maintain research follow-up whether or not the subject is retained in treatment.  The analysis will be under intent-to-treat.  The primary outcomes of interest are 1) recruitment and retention in the study and 2) illicit drug use and criminal behavior (as determined by the Europ-ASI) at 12 months. Secondary outcomes are measures of social function (e.g., social integration and functioning, quality of life) and cost-benefit/effectiveness of the interventions.

Phase

Phase 3

Study type

Interventional

Study design

Treatment

Study design

Randomized

Study design

Open Label

Study design

Parallel Assignment

Study design

Efficacy Study

Primary outcome

Measure: Recruitment and retention in the study at 12 months
Time Frame: 12 months
Safety Issue? No

Primary outcome

Measure: Illicit drug use and criminal behavior at 12 months.
Time Frame: 12 months
Safety Issue? No

Secondary outcome

Measure: social integration, functioning, quality of life at 12 and 24 months; and cost-effectiveness at 12 months
Time Frame: 24 months
Safety Issue? No

Condition

Opiate Addiction

Arm/Group

Arm Label: 1         Active Comparator

Oral methadone

Arm/Group

Arm Label: 2         Experimental

Injected diacetylmorphine

Intervention

Drug: Methadone         Arm Label: 1

The dose of the drug will be determined by a physician. The oral drug will be administered 1 dose per days, 7 days per week.

Intervention

Drug: Diamorphine hydrochloride         Arm Label: 2

The dose of the drug will be determined by a physician. The injected drug will be administered up to 3 doses per day, 7 days per week.

URL

http://www.naomistudy.ca

See also

 

Recruitment Information

Status

Active, not recruiting

Start date

2005-03

Last follow-up date

2013-06 (Anticipated)

Primary completion date

2008-06 (Actual)

Criteria

 

Inclusion Criteria:
a. Opioid Dependence as confirmed by DSM-IV diagnostic criteria
b. 25 years of age or older
c. 5 years or more of opioid use
d. Regular opioid injection use in the past month and in at least 8 months in the past 12 months (self reported; regular use - defined as injecting opioids for at least 4 days or more in a week); 50% or more of the injections during the prior year must have involved heroin).
e. Minimum of one-year residence in site/city location
f. No enrollment in any other opioid substitution (e.g. methadone) program within the prior 6 months - enrollment is defined as having received at least 45 milligrams of prescribed methadone per day on any 30 consecutive days or more in the prior 6 months
g. At least two previous episodes of opiate addiction treatment (methadone maintenance, detoxification, residential care, etc) during which, on at least one occasion, the patient received at least 60 mg of methadone daily for at least 30 days in a 40 day period
h. Willingness and ability to adhere to study protocol and follow-up schedule as determined through the three-week pre-randomization period (see Section C.4)
i. Documentation of fulfillment of the above study criteria (prison records, treatment records, cohort study enrollment, urine sampling)
j. Provide written and informed consent.


Exclusion Criteria:
a. Diagnosis of severe medical or psychiatric conditions that are contra-indicated for heroin treatment
b. Pregnancy upon study entry
c. On parole or with current justice system involvement that is likely to result in an extended period of incarceration (more than 4 months) during the study period
(e.g. scheduled trial for an indictable offense, jail, etc)
d. Hydromorphone is a class C teratogen and should not be given to pregnant women. All female subjects upon study entry will be urged to engage only in protected sexual intercourse and will provide consent to undergo monthly pregnancy tests during the course of the study.
e. Serum bilirubin >2.5 x normal
f. Stage II or greater hepatic encephalopathy
g. Chronic respiratory disease resulting in resting respiratory rate >20/minute
h. Bipolar Mood Disorder, Schizophrenia or other psychotic disorder with active psychotic symptoms within the past 6 months
i. Major Depression refractory to medical management or requiring electroconvulsive therapy within the past 12 months.

Gender

Both

Minimum age

25 Years

Healthy volunteers

No

Administrative Data

Organization name

University of British Columbia

Organization study ID

P99-0209

Secondary ID

03-2316

 

Results

The primary outcomes were determined in 95.2% of the participants. On the basis of an intention-to-treat analysis, the rate of retention in addiction treatment in the diacetylmorphine group was 87.8%, as compared with 54.1% in the methadone group (rate ratio for retention, 1.62; 95% confidence interval [CI], 1.35 to 1.95; P<0.001). The reduction in rates of illicit-drug use or other illegal activity was 67.0% in the diacetylmorphine group and 47.7% in the methadone group (rate ratio, 1.40; 95% CI, 1.11 to 1.77; P = 0.004). The most common serious adverse events associated with diacetylmorphine injections were overdoses (in 10 patients) and seizures (in 6 patients).


Conclusions
Injectable diacetylmorphine was more effective than oral methadone. Because of a risk of overdoses and sezures, diacetylmorphine maintenance therapy should be delivered in settings where prompt medical intervention is available. (ClinicalTrials.gov number, NCT00175357.)
Copyright © 2009 Massachusetts Medical Society. All rights reserved.
Downloaded from www.nejm.org at MCGILL UNIVERSITY LIBRARY on June 21, 2010 .


(FY2014 Federal Drug Control Budget) "In support of the 2013 National Drug Control Strategy (Strategy), the President requests $25.4 billion in Fiscal Year (FY) 2014 to reduce drug use and its consequences in the United States. This represents an increase of $0.9 billion (3.7%) over the FY 2012 final level of $24.5 billion."

Source: 

 National Drug Control Budget: FY 2014 Funding Highlights,"

Executive Office of the President, Office of National Drug Control Policy, April 2013, p. 2.

Federal Drug Control Spending by Function
(Budget Authority in Millions)

Function

FY 2012     

 FY 2013

FY 2014

Request

       

Treatment

7,848.3

8,082.4

9,261.6

Percent

32.0%

32.9%

36.5%

    nbsp;  

Prevention

1,339.2

1,289.5

1,408.7

Percent

5.5%

5.3%

5.5%

       

Domestic Law Enforcement

9,439.5

9.348.8

9,562.9

Percent

38.5%

38.1%

37.7%

       

Interdiction

4,036.5

3,869.7

3,705.0

Percent

16.5%

15.8%

14.6%

       

International

1,833.7

1,946.0

1,455.0

Percent

7.5%

7.9%

5.7%

       

Total

$24,497.2

$24,536.4

$25,393.2

       

Comments