<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02213614</url>
  </required_header>
  <id_info>
    <org_study_id>vio829429989</org_study_id>
    <nct_id>NCT02213614</nct_id>
  </id_info>
  <brief_title>Lithium Water in Gun Violence Prevention</brief_title>
  <acronym>LWGVP</acronym>
  <official_title>Lithium Water Use in Gun Violence Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Society Of Thermalism And Climatology Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American Society Of Thermalism And Climatology Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The word lithium frequently conjures images of catatonic psychiatric patients and side&#xD;
      effects so severe that premature death is commonplace. But naturally occurring lithium is a&#xD;
      far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an&#xD;
      essential mineral for maintaining physical and mental health. When exposure is low, suicide&#xD;
      rates, mental illness and violent crime increase&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lithium has a long history of use in the treatment of mental disorders. However, it hasn't&#xD;
      been until recently that scientists began exploring the psychiatric implications of naturally&#xD;
      occurring lithium in the water supply.&#xD;
&#xD;
      As stated in the article, Foods Rich in Lithium And Lithium Supplements:&#xD;
&#xD;
      &quot;Research suggests that locations with the highest concentration of lithium tend to have the&#xD;
      lowest rates of depression and violent crime. These studies have been conducted across the&#xD;
      globe in different climates with different natural habits and diets. Researchers have&#xD;
      therefore concluded that this phenomenon is fairly universal.&quot;&#xD;
&#xD;
      A study in the United States agrees with these findings. According to Everything Addiction:&#xD;
&#xD;
      &quot;In a 1990 study of 27 Texas counties, researchers found an &quot;inverse association of tap water&#xD;
      lithium content in areas of Texas with the rates of mental hospital admissions, suicides,&#xD;
      homicides, and certain other crimes.&quot; It was also discovered that young men incarcerated for&#xD;
      violent crimes in some parts of Texas had disproportionately low lithium levels. Schrauzer&#xD;
      and Shrestha discovered that the negative correlation was confirmed,&quot; especially in the&#xD;
      south-central region of the state where high suicide mortality rates correspond to low&#xD;
      lithium concentrations.&quot;'&#xD;
&#xD;
      Another study published in the British Journal of Psychiatry had similar results. Researchers&#xD;
      at Oita University examined the suicide rates in Japan's Oita prefecture. The team discovered&#xD;
      that cities with higher levels of natural lithium in the public water supply had lower rates&#xD;
      of suicide overall.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change behavioral tendencies due to lithium water treatment</measure>
    <time_frame>1 year</time_frame>
    <description>During the next study we will analyze the behavior of violent tendencies in three counties of New Jersey (ESSEX, Hudson and Passaic) during the years 2010-2013, different parameters were identified such as:&#xD;
Firearms violence Domestic violence Killings Rape Theft Suicides Alcoholism Substance abuse We will Identify 400 individuals randomly with one or more of these known behaviors, which are invited to participate in the study, we will administer them a psycho-social test, a history clinical psycho-social study, levels of lithium in blood test and associated general tests, in addition to EEG, and neuro-physiological studies.&#xD;
500 mcg will be given to one group which will indicate them a daily supplement of lithium water while the other group will only receive mineral spring water as a placebo.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Assault by Handgun Discharge</condition>
  <condition>Violence</condition>
  <condition>Homicide</condition>
  <condition>Sexual Assault by Bodily Force</condition>
  <condition>Substance Abuse Problem</condition>
  <arm_group>
    <arm_group_label>Spring Lithium Water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Long term goal of this research project is the implementation of an effective, inexpensive therapy in communities with high risk of violence. Therapy will be based on a daily dietary supplement LIWA at appropriate doses.&#xD;
The short-term objective is to prove that Lithium water (LIWA) as a daily supplement is an intervention that prevents gun violence from occurring, and is a factor that decrease the violence for gun in our communities Gun violence poses a serious threat to America's children and youth. Existing data clearly point to the need for improved strategies for keeping guns out of the hands of children and youth and those who would harm them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo: Natural Spring water</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be drink natural spring water for 4 months in tres cicles</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lithium Water</intervention_name>
    <description>Supply daily doses of Lithium water in form bottled mineral water</description>
    <arm_group_label>Spring Lithium Water</arm_group_label>
    <other_name>Spring mineral water</other_name>
    <other_name>Crazy water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo: spring mineral water</intervention_name>
    <description>Drink spring natural water a placebo 3 times a day</description>
    <arm_group_label>Placebo: Natural Spring water</arm_group_label>
    <other_name>natural water</other_name>
    <other_name>spring water</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>natural spring water</intervention_name>
    <description>A group will drink natural spring water for 4 months</description>
    <arm_group_label>Placebo: Natural Spring water</arm_group_label>
    <other_name>natural water</other_name>
    <other_name>spring water</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 14-60.&#xD;
&#xD;
          -  Existence of alcoholism, substance abuse, violence antecedent, suicide history&#xD;
             Answered all questions in the pre-treatment safety questionnaire. Gave their oral and&#xD;
             written consent to participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with renal failure, cardiovascular insufficiency, Addison's disease and untreated&#xD;
        hypothyroidism.&#xD;
&#xD;
        Pregnancy. Patients who have vomiting or diarrhea or if fluid or salt (sodium) intake is&#xD;
        increased or decreased.&#xD;
&#xD;
        Inadequate communication with examiner. Participation in another clinical study, either&#xD;
        concurrent with this trial or in the 3 months preceding it.&#xD;
&#xD;
        Inability to sign a consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Garis Silega</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Society of Thermalism and Climatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Garis Silega, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>American Society of Thermalism and Climatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gaviota Clinic</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>June 22, 2015</last_update_submitted>
  <last_update_submitted_qc>June 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lithium Carbonate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02213614
org study id: vio829429989
nct id: NCT02213614
lead sponsor: 
has dmc: Yes
The word lithium frequently conjures images of catatonic psychiatric patients and side
      effects so severe that premature death is commonplace. But naturally occurring lithium is a
      far cry from pharmaceutical grades. Found in the soil, water and certain foods, it is an
      essential mineral for maintaining physical and mental health. When exposure is low, suicide
      rates, mental illness and violent crime increase
Lithium has a long history of use in the treatment of mental disorders. However, it hasn't
      been until recently that scientists began exploring the psychiatric implications of naturally
      occurring lithium in the water supply.

      As stated in the article, Foods Rich in Lithium And Lithium Supplements:

      "Research suggests that locations with the highest concentration of lithium tend to have the
      lowest rates of depression and violent crime. These studies have been conducted across the
      globe in different climates with different natural habits and diets. Researchers have
      therefore concluded that this phenomenon is fairly universal."

      A study in the United States agrees with these findings. According to Everything Addiction:

      "In a 1990 study of 27 Texas counties, researchers found an "inverse association of tap water
      lithium content in areas of Texas with the rates of mental hospital admissions, suicides,
      homicides, and certain other crimes." It was also discovered that young men incarcerated for
      violent crimes in some parts of Texas had disproportionately low lithium levels. Schrauzer
      and Shrestha discovered that the negative correlation was confirmed," especially in the
      south-central region of the state where high suicide mortality rates correspond to low
      lithium concentrations."'

      Another study published in the British Journal of Psychiatry had similar results. Researchers
      at Oita University examined the suicide rates in Japan's Oita prefecture. The team discovered
      that cities with higher levels of natural lithium in the public water supply had lower rates
      of suicide overall.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change behavioral tendencies due to lithium water treatment
time frame: 1 year
description: During the next study we will analyze the behavior of violent tendencies in three counties of New Jersey (ESSEX, Hudson and Passaic) during the years 2010-2013, different parameters were identified such as:
Firearms violence Domestic violence Killings Rape Theft Suicides Alcoholism Substance abuse We will Identify 400 individuals randomly with one or more of these known behaviors, which are invited to participate in the study, we will administer them a psycho-social test, a history clinical psycho-social study, levels of lithium in blood test and associated general tests, in addition to EEG, and neuro-physiological studies.
500 mcg will be given to one group which will indicate them a daily supplement of lithium water while the other group will only receive mineral spring water as a placebo.
arm group label: Spring Lithium Water
arm group type: Experimental
description: The Long term goal of this research project is the implementation of an effective, inexpensive therapy in communities with high risk of violence. Therapy will be based on a daily dietary supplement LIWA at appropriate doses.
The short-term objective is to prove that Lithium water (LIWA) as a daily supplement is an intervention that prevents gun violence from occurring, and is a factor that decrease the violence for gun in our communities Gun violence poses a serious threat to America's children and youth. Existing data clearly point to the need for improved strategies for keeping guns out of the hands of children and youth and those who would harm them.
arm group label: Placebo: Natural Spring water
arm group type: Experimental
description: This group will be drink natural spring water for 4 months in tres cicles
intervention type: Dietary Supplement
intervention name: Lithium Water
description: Supply daily doses of Lithium water in form bottled mineral water
arm group label: Spring Lithium Water
other name: Spring mineral water
other name: Crazy water
intervention type: Dietary Supplement
intervention name: placebo: spring mineral water
description: Drink spring natural water a placebo 3 times a day
arm group label: Placebo: Natural Spring water
other name: natural water
other name: spring water
intervention type: Other
intervention name: natural spring water
description: A group will drink natural spring water for 4 months
arm group label: Placebo: Natural Spring water
other name: natural water
other name: spring water
criteria: 
gender: All
minimum age: 14 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Garis Silega
role: Principal Investigator
affiliation: American Society of Thermalism and Climatology
last name: Garis Silega, Doctor
role: Study Director
affiliation: American Society of Thermalism and Climatology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Lithium Carbonate