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| ID | Type | Description | Link |
|---|---|---|---|
| AD-2018C1-11098 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The study will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.
Through workshops and ongoing supervision/consultation, researchers will train MaleSurvivor peer leaders to competently deliver both versions of MI and conduct a randomized controlled trial comparing the two versions of MI to enhance treatment engagement in SGM male survivors with mental health problems. All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week MI delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Randomization will be counterbalanced by treatment status: treatment naive versus treatment-experienced (prior treatment but not within the past 60 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental | Sexual and gender minority males who are sexual abuse survivors. |
|
| MI with trauma-informed SGM affirmative care | Active Comparator | MI w/trauma-informed SGM affirmative care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-informed SGM affirmative care | Behavioral | All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Engage in Mental Health Treatment | The number of participants who initiated mental health treatment/reinitiated mental health treatment versus those who did not. Mental health treatment engagement will be operationally defined as having ≥1 visit(s) or scheduled appointments to any mental health services within 120 days of the last online group. | Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up. |
| Center for Epidemiological Studies Depression Scale | This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder. | Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Post Traumatic Stress Disorder | PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) , DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that corresponds to the current psychiatric diagnostic criteria for PTSD. Participants respond on a Likert scale ranging from 0 (not at all) to 4 (extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 (moderately) or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (Intrusion symptoms; questions 1-5), 1 Criterion C item (Avoidance symptoms; questions 6-7), 2 Criterion D items (Alternations in cognitions and mood; questions 8-14), 2 Criterion E items (Alterations in arousal and reactivity; questions 15-20). A PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80. |
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Inclusion Criteria:
Exclusion Criteria:
Men who have sex with men or individuals identifying as sexual gender minority (SGM) males who report a history of sexual abuse.
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| Name | Affiliation | Role |
|---|---|---|
| Joan Cook, Phd | Yale School of Medicine Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40113455 | Derived | Mandavia AD, Banducci AN, Simpson TL, Marx BP, Hawn SE, Hyde J, Ameral VE, Sistad Hall RE, Roth CE, Sarpong AA, Davenport M, Meng F, Stein MD, Livingston NA. Sex Differences in Suicide, Lethal Means, and Years of Potential Life Lost Among Veterans With Substance Use Disorder. Womens Health Issues. 2025 May-Jun;35(3):196-204. doi: 10.1016/j.whi.2025.02.002. Epub 2025 Mar 19. | |
| 37795783 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing | Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: Major principles and tenets of Motivational Interviewing (MI) group include: Non-confrontational nature of group; environment is one of respect, safety, and encouragement of all group members; purpose is to learn about members' personal thoughts and choices and not to push an "agenda" |
| FG001 | MI With Trauma-informed SGM Affirmative Care | MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing | Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: Major principles and tenets of Motivational Interviewing (MI) group include: Non-confrontational nature of group; environment is one of respect, safety, and encouragement of all group members; purpose is to learn about members' personal thoughts and choices and not to push an "agenda" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 356 were randomized and analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Engage in Mental Health Treatment | The number of participants who initiated mental health treatment/reinitiated mental health treatment versus those who did not. Mental health treatment engagement will be operationally defined as having ≥1 visit(s) or scheduled appointments to any mental health services within 120 days of the last online group. | Posted | Count of Participants | Participants | Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up. |
|
From baseline to 120-day follow-up, approximately 170 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interviewing | Sexual and gender minority males who are sexual abuse survivors. Motivational Interviewing: Major principles and tenets of Motivational Interviewing (MI) group include: Non-confrontational nature of group; environment is one of respect, safety, and encouragement of all group members; purpose is to learn about members' personal thoughts and choices and not to push an "agenda" |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Suicidality | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joan Cook | Yale University, School of Medicine | 203-856-2782 | joan.cook@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 18, 2021 | Oct 13, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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randomized comparative
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|
| Motivational Interviewing | Behavioral | Major principles and tenets of Motivational Interviewing (MI) group include: Non-confrontational nature of group; environment is one of respect, safety, and encouragement of all group members; purpose is to learn about members' personal thoughts and choices and not to push an "agenda" |
|
| Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up. |
| Psychosocial Functioning | Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-item scale that assesses functional impairment or quality of life related to trauma and PTSD. Questions assess for impairment in romantic relationships, family relationships, work, friendships and socializing, parenting, academic pursuits, and self-care. Higher scores indicate greater functional impairment. Respondents answer each item by using a 7-point scale ranging from 1 ("never") to 7 ("always"). The IPF yields an overall functional impairment score. | Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day |
| Substance Abuse | The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8-item measure of use of alcohol, tobacco products, and other drugs across the lifespan and in the past 3 months. The test has been shown to be a valid indicator of active substance use with adequate construct validity. Scores are summed across for each drug category separately with a maximum score for tobacco = 31 and a maximum score for each of the other drug categories = 39. A Global Continuum of Risk Score can also be calculated by summing all items for all drug classes together with a maximum score of 414. Scores are categorized into Low (0 - 3), Moderate (4 - 26), and High (27+) risk. | Baseline (immediately pre-intervention) |
| Substance Abuse | The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8-item measure of use of alcohol, tobacco products, and other drugs across the lifespan and in the past 3 months. The test has been shown to be a valid indicator of active substance use with adequate construct validity. Scores are summed across for each drug category separately with a maximum score for tobacco = 31 and a maximum score for each of the other drug categories = 39. A Global Continuum of Risk Score can also be calculated by summing all items for all drug classes together with a maximum score of 414. Scores are categorized into Low (0 - 3), Moderate (4 - 26), and High (27+) risk. | Post-intervention (immediately following last online group) |
| Derived |
| O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2. |
| Protocol Violation |
|
| BG001 | MI With Trauma-informed SGM Affirmative Care | MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Mental Health Treatment History | Count of Participants | Participants |
|
| Depression (CES-D) | This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder. Baseline CESDs values reported, unadjusted for covariates. | Mean | Standard Deviation | units on a scale |
|
| OG001 | MI With Trauma-informed SGM Affirmative Care | MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use). |
|
|
| Primary | Center for Epidemiological Studies Depression Scale | This is a 20-item questionnaire that asks about experience and frequency of depressive symptoms over the past week. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. A score of 16 or higher identifies those individuals who are at risk for major depression (which is equivalent to endorsing at least 6 out of 20 symptoms for depression. Researchers will be looking for scores to reduce to below 16, indicating a lack of criteria being met for major depressive disorder. | For outcome analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures outcome variable, nested within participants, and nested within cohorts. Baseline values of the dependent variable, along with any baseline characteristics that differentiated the two groups, were included as time-invariant covariates (between participants), as was treatment group. | Posted | Mean | Standard Error | score on a scale | Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up. |
|
|
|
| Secondary | Post Traumatic Stress Disorder | PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) , DSM-5 (PCL-5; Weathers et al., 2013) is a 20-item instrument that corresponds to the current psychiatric diagnostic criteria for PTSD. Participants respond on a Likert scale ranging from 0 (not at all) to 4 (extremely). A provisional PTSD diagnosis can be made by treating each item rated as 2 (moderately) or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 Criterion B item (Intrusion symptoms; questions 1-5), 1 Criterion C item (Avoidance symptoms; questions 6-7), 2 Criterion D items (Alternations in cognitions and mood; questions 8-14), 2 Criterion E items (Alterations in arousal and reactivity; questions 15-20). A PCL-5 cut-point of 33 appears to be a reasonable value to use for provisional PTSD diagnosis. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80. | For outcome analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures outcome variable, nested within participants, and nested within cohorts. Baseline values of the dependent variable, along with any baseline characteristics that differentiated the two groups, were included as time-invariant covariates (between participants), as was treatment group. | Posted | Mean | Standard Error | score on a scale | Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up. |
|
|
|
| Secondary | Psychosocial Functioning | Inventory of Psychosocial Functioning (IPF-B; Rodriguez, Holowka, & Marx, 2012) is a brief 7-item scale that assesses functional impairment or quality of life related to trauma and PTSD. Questions assess for impairment in romantic relationships, family relationships, work, friendships and socializing, parenting, academic pursuits, and self-care. Higher scores indicate greater functional impairment. Respondents answer each item by using a 7-point scale ranging from 1 ("never") to 7 ("always"). The IPF yields an overall functional impairment score. | For outcome analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures outcome variable, nested within participants, and nested within cohorts. Baseline values of the dependent variable, along with any baseline characteristics that differentiated the two groups, were included as time-invariant covariates (between participants), as was treatment group. | Posted | Mean | Standard Error | score on a scale | Baseline (immediately pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day |
|
|
|
| Secondary | Substance Abuse | The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8-item measure of use of alcohol, tobacco products, and other drugs across the lifespan and in the past 3 months. The test has been shown to be a valid indicator of active substance use with adequate construct validity. Scores are summed across for each drug category separately with a maximum score for tobacco = 31 and a maximum score for each of the other drug categories = 39. A Global Continuum of Risk Score can also be calculated by summing all items for all drug classes together with a maximum score of 414. Scores are categorized into Low (0 - 3), Moderate (4 - 26), and High (27+) risk. | For outcome analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures outcome variable, nested within participants, and nested within cohorts. Baseline values of the dependent variable, along with any baseline characteristics that differentiated the two groups, were included as time-invariant covariates (between participants), as was treatment group. | Posted | Mean | Standard Error | score on a scale | Baseline (immediately pre-intervention) |
|
|
|
| Secondary | Substance Abuse | The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) is an 8-item measure of use of alcohol, tobacco products, and other drugs across the lifespan and in the past 3 months. The test has been shown to be a valid indicator of active substance use with adequate construct validity. Scores are summed across for each drug category separately with a maximum score for tobacco = 31 and a maximum score for each of the other drug categories = 39. A Global Continuum of Risk Score can also be calculated by summing all items for all drug classes together with a maximum score of 414. Scores are categorized into Low (0 - 3), Moderate (4 - 26), and High (27+) risk. | For outcome analyses, linear mixed models (LMM) of mental health symptoms were modeled as a repeated measures outcome variable, nested within participants, and nested within cohorts. Baseline values of the dependent variable, along with any baseline characteristics that differentiated the two groups, were included as time-invariant covariates (between participants), as was treatment group. | Posted | Mean | Standard Error | score on a scale | Post-intervention (immediately following last online group) |
|
|
|
| 0 |
| 178 |
| 2 |
| 178 |
| 5 |
| 178 |
| EG001 | MI With Trauma-informed SGM Affirmative Care | MI w/trauma-informed SGM affirmative care Trauma-informed SGM affirmative care: All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups. Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use). | 0 | 178 | 0 | 178 | 12 | 178 |
| Sexual Assault | Psychiatric disorders | Non-systematic Assessment |
|
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| 60-day follow-up |
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| 120-day follow-up |
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| 60-day follow-up |
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| 120-day follow-up |
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| 60-day follow-up |
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| 120-day follow-up |
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| Marijuana |
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| Cocaine |
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| Amphetamine/ Stimulant |
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| Inhalants |
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| Sedatives |
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| Hallucinogens |
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| Opioids |
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| Other |
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| Medical Marijuana |
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| Marijuana |
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| Cocaine |
|
| Amphetamine/ Stimulant |
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| Inhalants |
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| Sedatives |
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| Hallucinogens |
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| Opioids |
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| Other |
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| Medical Marijuana |
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