7 | 6 | | Citations Affected: IC 16-18; IC 16-46. |
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8 | 7 | | Synopsis: Psilocybin treatment program. Establishes the therapeutic |
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9 | 8 | | psilocybin research fund, administered by the Indiana department of |
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10 | 9 | | health (state department), to provide financial assistance to research |
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11 | 10 | | institutions in Indiana to study the use of psilocybin to treat mental |
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12 | 11 | | health and other medical conditions. Sets forth clinical study |
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13 | 12 | | requirements. Requires a research institution that receives a grant to |
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14 | 13 | | conduct a clinical study to prepare and submit a report to the interim |
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15 | 14 | | study committee on public health, behavioral health, and human |
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16 | 15 | | services, the state department, and the division of mental health and |
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17 | 16 | | addiction. |
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18 | 17 | | Effective: Upon passage. |
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19 | 18 | | Charbonneau, Johnson T, Busch, |
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20 | 19 | | Yoder, Pol Jr., Randolph Lonnie M |
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28 | | - | February 5, 2024, read second time, ordered engrossed. Engrossed. |
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29 | | - | February 6, 2024, read third time, passed. Yeas 47, nays 1. |
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30 | | - | HOUSE ACTION |
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31 | | - | February 12, 2024, read first time and referred to Committee on Public Health. |
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32 | | - | February 13, 2024, amended, reported — Do Pass. Referred to Committee on Ways and |
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33 | | - | Means pursuant to Rule 127. |
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34 | | - | ES 139—LS 6465/DI 147 February 13, 2024 |
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| 25 | + | SB 139—LS 6465/DI 147 February 2, 2024 |
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35 | 26 | | Second Regular Session of the 123rd General Assembly (2024) |
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36 | 27 | | PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana |
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37 | 28 | | Constitution) is being amended, the text of the existing provision will appear in this style type, |
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38 | 29 | | additions will appear in this style type, and deletions will appear in this style type. |
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39 | 30 | | Additions: Whenever a new statutory provision is being enacted (or a new constitutional |
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40 | 31 | | provision adopted), the text of the new provision will appear in this style type. Also, the |
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41 | 32 | | word NEW will appear in that style type in the introductory clause of each SECTION that adds |
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42 | 33 | | a new provision to the Indiana Code or the Indiana Constitution. |
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43 | 34 | | Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts |
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44 | 35 | | between statutes enacted by the 2023 Regular Session of the General Assembly. |
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46 | 36 | | SENATE BILL No. 139 |
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47 | 37 | | A BILL FOR AN ACT to amend the Indiana Code concerning |
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48 | 38 | | health and to make an appropriation. |
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49 | 39 | | Be it enacted by the General Assembly of the State of Indiana: |
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50 | 40 | | 1 SECTION 1. IC 16-18-2-143, AS AMENDED BY P.L.1-2010, |
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51 | 41 | | 2 SECTION 69, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE |
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52 | 42 | | 3 UPON PASSAGE]: Sec. 143. (a) "Fund", for purposes of IC 16-26-2, |
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53 | 43 | | 4 has the meaning set forth in IC 16-26-2-2. |
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54 | 44 | | 5 (b) "Fund", for purposes of IC 16-31-8.5, has the meaning set forth |
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55 | 45 | | 6 in IC 16-31-8.5-2. |
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56 | 46 | | 7 (c) "Fund", for purposes of IC 16-41-39.4, refers to the childhood |
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57 | 47 | | 8 lead poisoning prevention fund established by IC 16-41-39.4-3.1. |
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58 | 48 | | 9 (d) "Fund", for purposes of IC 16-41-39.8, refers to the lead trust |
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59 | 49 | | 10 fund established by IC 16-41-39.8-7. |
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60 | 50 | | 11 (e) "Fund", for purposes of IC 16-46-5, has the meaning set forth in |
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61 | 51 | | 12 IC 16-46-5-3. |
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62 | 52 | | 13 (f) "Fund", for purposes of IC 16-46-12, has the meaning set forth |
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63 | 53 | | 14 in IC 16-46-12-1. |
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64 | 54 | | 15 (g) "Fund", for purposes of IC 16-41-42.2, has the meaning set forth |
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65 | 55 | | 16 in IC 16-41-42.2-2. |
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66 | 56 | | 17 (h) "Fund", for purposes of IC 16-35-8, has the meaning set forth in |
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68 | 58 | | 1 IC 16-35-8-2. |
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69 | 59 | | 2 (i) "Fund", for purposes of IC 16-46-17.5, has the meaning set |
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70 | 60 | | 3 forth in IC 16-46-17.5-1. |
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71 | 61 | | 4 SECTION 2. IC 16-18-2-296.4 IS ADDED TO THE INDIANA |
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72 | 62 | | 5 CODE AS A NEW SECTION TO READ AS FOLLOWS |
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73 | 63 | | 6 [EFFECTIVE UPON PASSAGE]: Sec. 296.4. "Psilocybin", for |
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74 | 64 | | 7 purposes of IC 16-46-17.5, has the meaning set forth in |
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75 | 65 | | 8 IC 16-46-17.5-2. |
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76 | 66 | | 9 SECTION 3. IC 16-46-17.5 IS ADDED TO THE INDIANA CODE |
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77 | 67 | | 10 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE |
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78 | 68 | | 11 UPON PASSAGE]: |
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79 | 69 | | 12 Chapter 17.5. Therapeutic Psilocybin Research |
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80 | 70 | | 13 Sec. 1. As used in this chapter, "fund" refers to the therapeutic |
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81 | 71 | | 14 psilocybin research fund established by section 3 of this chapter. |
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82 | 72 | | 15 Sec. 2. (a) As used in this chapter, "psilocybin" means a |
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83 | 73 | | 16 naturally occurring psychedelic prodrug compound that is |
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84 | 74 | | 17 produced by fungi, including members of the genus psilocybe. |
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85 | 75 | | 18 (b) The term includes psilocin. |
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86 | 76 | | 19 Sec. 2.5. As used in this chapter, "research institution" refers to |
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87 | 77 | | 20 an organization that meets all of the following: |
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88 | 78 | | 21 (1) Has an academic institution that operates an institutional |
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89 | 79 | | 22 review board (IRB) that oversees research. |
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90 | 80 | | 23 (2) Publishes the results of previous clinical trials in peer |
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91 | 81 | | 24 reviewed publications. |
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92 | 82 | | 25 (3) Has access to a clinical research center and the center's |
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93 | 83 | | 26 resources, including research dedicated medical staff. |
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94 | 84 | | 27 Sec. 3. The therapeutic psilocybin research fund is established |
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95 | 85 | | 28 for the purpose of providing financial assistance to research |
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96 | 86 | | 29 institutions in Indiana to study, in accordance with the |
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97 | 87 | | 30 requirements established in section 6 of this chapter, the use of |
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98 | 88 | | 31 psilocybin to treat mental health and other medical conditions. |
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99 | 89 | | 32 Sec. 4. (a) The fund shall be administered by the state |
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100 | 90 | | 33 department. |
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101 | 91 | | 34 (b) The expenses of administering the fund shall be paid from |
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102 | 92 | | 35 money in the fund. |
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103 | 93 | | 36 Sec. 5. (a) The fund consists of: |
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104 | 94 | | 37 (1) money received from state or federal grants or programs; |
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105 | 95 | | 38 and |
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106 | 96 | | 39 (2) gifts, money, and donations received from any other |
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107 | 97 | | 40 source, including transfers from other funds or accounts. |
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108 | 98 | | 41 (b) The treasurer of state shall invest the money in the fund not |
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109 | 99 | | 42 currently needed to meet the obligations of the fund in the same |
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111 | 101 | | 1 manner as other public money may be invested. Interest that |
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112 | 102 | | 2 accrues from these investments shall be deposited in the fund. |
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113 | 103 | | 3 (c) Money in the fund at the end of a state fiscal year does not |
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114 | 104 | | 4 revert to the state general fund. |
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115 | 105 | | 5 (d) Money in the fund is continuously appropriated for purposes |
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116 | 106 | | 6 of this chapter. |
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117 | 107 | | 7 Sec. 6. (a) A research institution in Indiana may apply to the |
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118 | 108 | | 8 state department to receive financial assistance from the fund to |
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119 | 109 | | 9 conduct one (1) or more clinical studies to evaluate the efficacy of |
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120 | 110 | | 10 psilocybin as an alternative treatment for mental health and other |
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121 | 111 | | 11 medical conditions, including the following: |
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122 | 112 | | 12 (1) Posttraumatic stress disorder, with a focus on treating the |
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123 | 113 | | 13 disorder in combat veterans and first responders. |
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124 | 114 | | 14 (2) Anxiety. |
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125 | 115 | | 15 (3) Depression. |
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126 | 116 | | 16 (4) Bipolar disorder. |
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127 | 117 | | 17 (5) Chronic pain. |
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128 | 118 | | 18 (6) Migraines. |
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129 | | - | 19 (7) Alcohol use disorder. |
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130 | | - | 20 (8) Tobacco use disorder. |
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131 | | - | 21 (b) In conducting a clinical study under this section, a research |
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132 | | - | 22 institution that receives a grant under this chapter shall do the |
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133 | | - | 23 following: |
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134 | | - | 24 (1) Include veterans and first responders in the study sample. |
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135 | | - | 25 (2) Evaluate and determine whether psilocybin is an effective |
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136 | | - | 26 treatment for mental health and other medical conditions |
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137 | | - | 27 described in subsection (a). |
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138 | | - | 28 (3) Compare the efficacy of psilocybin as a treatment for |
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139 | | - | 29 mental health and other medical conditions described in |
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140 | | - | 30 subsection (a) with the efficacy of other current treatment |
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141 | | - | 31 options for mental health and other medical conditions |
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142 | | - | 32 described in subsection (a). |
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143 | | - | 33 (4) Before entering the study, require each participant to |
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144 | | - | 34 undergo a mental health evaluation. |
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145 | | - | 35 Sec. 7. After a research institution that receives a grant under |
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146 | | - | 36 this chapter completes and finalizes a study under this chapter, a |
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147 | | - | 37 research institution shall prepare and submit a report |
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148 | | - | 38 summarizing the results of the study and any recommendations for |
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149 | | - | 39 legislation to the following: |
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150 | | - | 40 (1) The interim study committee on public health, behavioral |
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151 | | - | 41 health, and human services established by IC 2-5-1.3-4 in an |
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152 | | - | 42 electronic format under IC 5-14-6. |
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153 | | - | ES 139—LS 6465/DI 147 4 |
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154 | | - | 1 (2) The state department. |
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155 | | - | 2 (3) The division of mental health and addiction. |
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156 | | - | 3 Sec. 8. Not later than July 1, 2024, the state department shall |
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157 | | - | 4 establish a process to administer the fund and process applications |
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158 | | - | 5 under this chapter. |
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159 | | - | 6 SECTION 4. An emergency is declared for this act. |
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160 | | - | ES 139—LS 6465/DI 147 5 |
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| 119 | + | 19 (b) In conducting a clinical study under this section, a research |
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| 120 | + | 20 institution that receives a grant under this chapter shall do the |
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| 121 | + | 21 following: |
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| 122 | + | 22 (1) Include veterans and first responders in the study sample. |
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| 123 | + | 23 (2) Evaluate and determine whether psilocybin is an effective |
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| 124 | + | 24 treatment for mental health and other medical conditions |
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| 125 | + | 25 described in subsection (a). |
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| 126 | + | 26 (3) Compare the efficacy of psilocybin as a treatment for |
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| 127 | + | 27 mental health and other medical conditions described in |
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| 128 | + | 28 subsection (a) with the efficacy of other current treatment |
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| 129 | + | 29 options for mental health and other medical conditions |
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| 130 | + | 30 described in subsection (a). |
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| 131 | + | 31 (4) Before entering the study, require each participant to |
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| 132 | + | 32 undergo a mental health evaluation. |
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| 133 | + | 33 Sec. 7. After a research institution that receives a grant under |
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| 134 | + | 34 this chapter completes and finalizes a study under this chapter, a |
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| 135 | + | 35 research institution shall prepare and submit a report |
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| 136 | + | 36 summarizing the results of the study and any recommendations for |
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| 137 | + | 37 legislation to the following: |
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| 138 | + | 38 (1) The interim study committee on public health, behavioral |
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| 139 | + | 39 health, and human services established by IC 2-5-1.3-4 in an |
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| 140 | + | 40 electronic format under IC 5-14-6. |
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| 141 | + | 41 (2) The state department. |
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| 142 | + | 42 (3) The division of mental health and addiction. |
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| 143 | + | SB 139—LS 6465/DI 147 4 |
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| 144 | + | 1 Sec. 8. Not later than July 1, 2024, the state department shall |
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| 145 | + | 2 establish a process to administer the fund and process applications |
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| 146 | + | 3 under this chapter. |
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| 147 | + | 4 SECTION 4. An emergency is declared for this act. |
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| 148 | + | SB 139—LS 6465/DI 147 5 |
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161 | 149 | | COMMITTEE REPORT |
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162 | 150 | | Madam President: The Senate Committee on Health and Provider |
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163 | 151 | | Services, to which was referred Senate Bill No. 139, has had the same |
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164 | 152 | | under consideration and begs leave to report the same back to the |
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165 | 153 | | Senate with the recommendation that said bill be AMENDED as |
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166 | 154 | | follows: |
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167 | 155 | | Page 2, between lines 18 and 19, begin a new paragraph and insert: |
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168 | 156 | | "Sec. 2.5. As used in this chapter, "research institution" refers |
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169 | 157 | | to an organization that meets all of the following: |
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170 | 158 | | (1) Has an academic institution that operates an institutional |
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171 | 159 | | review board (IRB) that oversees research. |
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172 | 160 | | (2) Publishes the results of previous clinical trials in peer |
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173 | 161 | | reviewed publications. |
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174 | 162 | | (3) Has access to a clinical research center and the center's |
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175 | 163 | | resources, including research dedicated medical staff.". |
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176 | 164 | | Page 3, line 9, after "institution" insert "that receives a grant under |
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177 | 165 | | this chapter". |
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178 | 166 | | Page 3, line 21, after "institution" insert "that receives a grant |
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179 | 167 | | under this chapter". |
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180 | 168 | | and when so amended that said bill do pass and be reassigned to the |
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181 | 169 | | Senate Committee on Appropriations. |
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182 | 170 | | (Reference is to SB 139 as introduced.) |
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183 | 171 | | CHARBONNEAU, Chairperson |
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184 | 172 | | Committee Vote: Yeas 11, Nays 0. |
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185 | 173 | | _____ |
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186 | 174 | | COMMITTEE REPORT |
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187 | 175 | | Madam President: The Senate Committee on Appropriations, to |
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188 | 176 | | which was referred Senate Bill No. 139, has had the same under |
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189 | 177 | | consideration and begs leave to report the same back to the Senate with |
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190 | 178 | | the recommendation that said bill be AMENDED as follows: |
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191 | 179 | | Delete the title and insert the following: |
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192 | 180 | | A BILL FOR AN ACT to amend the Indiana Code concerning |
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193 | 181 | | health and to make an appropriation. |
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194 | 182 | | Page 2, line 36, delete "of the following:" and insert "of:". |
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195 | 183 | | Page 2, delete lines 37 through 39, begin a new line block indented |
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196 | 184 | | and insert: |
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209 | | - | _____ |
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210 | | - | COMMITTEE REPORT |
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211 | | - | Mr. Speaker: Your Committee on Public Health, to which was |
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212 | | - | referred Senate Bill 139, has had the same under consideration and |
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213 | | - | begs leave to report the same back to the House with the |
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214 | | - | recommendation that said bill be amended as follows: |
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215 | | - | Page 3, between lines 18 and 19, begin a new line block indented |
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216 | | - | and insert: |
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217 | | - | "(7) Alcohol use disorder. |
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218 | | - | (8) Tobacco use disorder.". |
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219 | | - | and when so amended that said bill do pass. |
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220 | | - | (Reference is to SB 139 as printed February 2, 2024.) |
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221 | | - | BARRETT |
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222 | | - | Committee Vote: yeas 12, nays 1. |
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223 | | - | ES 139—LS 6465/DI 147 |
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| 197 | + | SB 139—LS 6465/DI 147 |
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