Addiction and substance abuse is undermining the very moral fabric and future of America today. In 1995 it was estimated that the cost of alcohol and other drugs reached a staggering figure of 276 billion, not including the pain and suffering of loved ones and friends. Alcoholics have an estimated decrease in life expectancy of 10-15 years, with alcohol the most frequently used and abused intoxicant and involved in 40% of all fatal motor vehicle accidents (1 and 2).
Although not illegal, nicotine accounts for approximately 25 million people addicted and is the cause of 430,000 tobacco related deaths per year.
The most commonly abused opiates are, heroin and methadone. It has been estimated by the National Institute of Drug Abuse that approximately 2.5 million Americans have a history of heroin abuse (3).
Stimulants such as cocaine are widespread as well in America and it is estimated 72 million Americans have tried or are using or cocaine (3).
Methamphetamine is growing at an unstoppable rate due to the ease of making the drug, and is now competing with cocaine as a drug of choice.
Although there are numerous examples of addictive drugs in America they all show similar symptoms and qualities of craving and withdrawal conditions. The individuals at greatest risk are genetically predisposed through a neurochemical pathway that alters the minds perception of pleasure and reward. Kenneth Blum, coined the term, "Reward Deficiency Syndrome," to relate to the neurotransmitter deficit that occurs due to use of drugs and alcohol. Although the pathways may vary, depending on the abused substance, they all show a common final neurochemical pathway in their expression of euphoria when abundant, and craving when deficient.
The important Amino-peptide neurotransmitters to date are serotonin, dopamine, GABA and the enkephalins. Dopamine specifically is the neurotransmitter of pleasure. When dopamine is in abundance, it provides a state of well-being. Although this research will focus on alcohol, there are many other substances that can alter the increase in dopamine resulting in pleasure. Other altering scenarios can be glucose, impulsive/compulsive disorders, gambling and risk-taking activities, opiates, cocaine and cigarettes.
When the brain is supplied with a substance a momentary spike in neurotransmitter activity of dopamine occurs. The body then reacts to down regulate this excessive increase by down regulating the neurotransmitter sites of production or receptor sites, or by increasing the breakdown of neurotransmitters. Because of this, the brain develops tolerance and the need for more of the drug to prevent a state of withdrawal.
The point at which addiction can occur is variable and based on the individual's genes. Recently, the dopamine D2 receptor called the A1allele, has been known to be a greater prevalence for alcoholics, opiate or cocaine addicts.
This pleasure and reward system was discovered, by accident, in 1954 by James Otis. By mistake, Otis placed electrodes in the Para limbic system of rats. In doing so, Otis observed he could elicit a pleasure response. This response caused the rats to continuously press a lever, causing an electrical stimulation to this area even to the point of starvation. It was later noted that an increase in dopamine was being released in regions of the limbic system, specifically the nucleus accumbens and the hippocampus.
Recently, a pharmacological approach to alter these neurotransmitters and help people with reward deficiency syndrome has been found. Studies by Brown and Blum indicate that certain amino acid precursors can relieve cravings and reduce incidents of a relapse. Oral formulas have been formulated and produced with these amino acids, vitamins and minerals cofactors. Recently an intravenous pharmacological approach utilizing amino acid neurotransmitter precursors have shown to have an immediate and profound effect on craving reduction and withdrawals in 86% of the patients with no side effects noted by this researcher or by Excel treatment facility during the last two years. The intravenous amino acids, vitamins, and mineral therapy appears to augment the dopamine and serotonin levels while the body begins to return to better handling oral nutrients and neurotransmitter homeostasis.
This study has been implemented to determine the efficacy of intravenous amino acids to reduce withdrawal and craving from substance abuse.
Nine subjects were picked from phone in volunteers from a local Denver newspaper add (Exhibit 1).
Inclusion into the study are individuals who are between the ages of 18 and 50 years old, in good health, not court ordered and who desire to stop their substance abuse, but to date, are unable to do so. Methadone or a history of psychiatric hospitalize subjects are excluded from this study. All subjects will undergo a history and physical exam and a doctor will be present at all times. Initials will be used for publishing purposes only and strict confidentiality will be observed of all subjects.
The treatment subjects will undergo 10 sessions (Monday through Friday) of a multi amino acid, vitamin and mineral solution in a 250cc ½ NS bag group or a placebo group of Vitamins (B2, B12 and Folate) in a 250cc ½ NS bag with matching color and volume. All subjects will undergo drug testing for their addiction including random breath and/or urine drug tests.
If you smoke, you will be asked to keep track of the number of cigarettes smoked daily.
To be entered into the research group each individual must meet the requirement of the Diagnostic and Statistical Manual of Mental Disorders TR (DSM-IV TR) for an Axis-I drug dependence.
Axis-I 303.90 Alcohol Dependence
Axis-I 304.40 Amphetamine Dependence Including Methamphetamine
Axis-I 304.30 Cannabis Dependence
Axis-I 304.20 Cocaine Dependence
Axis-I 305.10 Nicotine Dependence
Axis-I 304.00 Opioid Dependence
Axis-I 304.90 Polysubstance-related Disorder
Other axis-I substance dependence disorders will be assessed on a case-by-case basis.
The research subjects will be placed randomly into two equal groups A and B.
The control-or placebo-group will receive an intravenous solution of 250 cc of a ½ normal saline bag with B2, B12 and folate to give the distinctive color to the bags.
The experimental group will be given an intravenous solution consisting of a patented formula titled TGGRS Treatment (Third Generation Genetic Repair System). The Tigers Treatment consists of multi amino acids, vitamins and mineral solution drip over a 1 & 2-hour period for 10 sessions. All subjects will be randomly be monitored by blowing a B.A.C. or urine drug tests. A questionnaire will also be required to rate their craving and anxiety symptoms each session. Specific cravings will be rated from a zero (0)-indicating no craving or withdrawal, to a ten (10)-indicating maximum craving or withdrawal symptoms.
The intravenous bags will be marked "Group A" and "Group B" and will be made by a local compounding pharmacist. He will have no contact with the subjects. Heart rate, blood pressure and level of subject mental status will be conducted before each session. During the study, all subjects will be asked to eliminate or cut back on their alcohol or drug consumption but at any time may voluntary return to their pre-study consumption level, or be asked to by the doctor, if sever withdrawal symptoms occur. Failure to participate in 90% of the study will be grounds for dismissal. The people involved in administering the I.V. and monitoring the people will not know which bags contain the amino acids and which contain the placebo. At the end of 10-days the pharmacists will expose which group was the experimental group and which group was the placebo group-A or B, respectively. At that time the experimental and the placebo groups will undergo a daily debriefing and questionnaire rating their withdrawal symptom success and anti-craving level.
At the end of 10 sessions, the treatment group will be given 5 additional treatments of the same solution with D-phenylalanine added. Afterwards, the placebo group will get the treatment solution for 5 sessions followed by 5 session with D-phenylalanine added. All subjects at the end of their intravenous sessions will be debriefed and given the opportunity to take a one months worth of a similar oral based formula for maintenance efficacy.
To stay sober, the war on addiction has many battlefronts to concour from dealing with initial withdrawals and craving to handling family and friend enablers, denial, stress, temptation and faith that we can overcome the disease that seals the heart, soul and life of mankind.
From Jan 21 until Feb 17th nine volunteers under took a major step to sobriety by introducing nutrition building blocks of neurotransmitters by intravenous means to battle withdrawal and cravings aspects. Only one individual had no response to our amino acids vitamin and mineral cocktail and continue daily drinking with no perceived change in anxiety and craving. All others expressed a significant response from moderate to profound anti-craving benefits by the end of the study.
The A group (RH, RY, KM, RA) received vitamins for the first 10 sessions, and although noticed a slight reduction in craving and anxiety, RY, KM, KA continued to drink. RH had marijuana addiction problems and throughout the study he did not use. The B group (RM, DR, RD, DB, JD) received the therapeutic formula less the D isomer of phenylalanine. They all continued drinking and showed no significant change in craving and anxiety. The A group noticed no significant change as well to 5 days of the therapeutic formula minus the D isomer. It wasn't until the last 5 days in both groups that a significant response in drinking reduction in sobriety along with cravings and anxiety reduction occurring.
The D isomer of phenylalanine appears to be a crucial component in withdrawal and craving issues. Addition to alcohol and drugs is caused by an imbalance or defiency of neurotransmitter activity in a cascade mode. Per Dr Blum serotonin releases enkephalin in the hypothalamus and enkephalin inhibits the release of GABA in the substantia nigra. The inhibition of GABA permits the release of dopamine in both the nucleus accumbens and the hippocampus.
Apparently up regulation of serotonin by tryptofan is not enough to release sufficient enkephalins to have an impact on up regulating dopamine despite direct stimulation of L-phenylalanine and L-tyrosine on increased dopamine production. The D form of phenylalanine, which inhibits enkephalin, appears paramount in the cascade theory and therefore causing substantial anxiety and craving reduction. Enkephlins are nature's natural painkillers and a reduction in pain appears critical to suppressing withdrawal and craving symptoms as well as balancing neurotransmitters. This study supports the 86% recovery rate in retrospective review of the current intravenous amino acid (TGGRS solution) being conducted at Excel treatment and recovery program. However, future clinical trials with genetic testing and greater numbers coupled with a variety of addictions would better support statistical efficacy of intravenous amino acid supplementation. In addition, why 10 to 15 percent of the population fail this program possibly could be cause from a yet unknown genetic pathway of metabolism with nationality possibly playing a role in this failure rate.
The TGGRS intravenous amino acid program in its current formula had statistical efficacy in nine patient's ability to handle their craving and anxiety perception and their ability to withdraw from alcohol. The D-phenylalanine isomer appears to be an essential ingredient to this formula. Together with education and counselling and nutrition, intravenous amino acid supplementation will prove to be a powerful tool in initially combating the evil grasp of addiction in today's society.