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The overall aim of this pilot study is to conduct a preliminary trial to evaluate the acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program for adolescents and young adults with substance use disorders and emotional distress. Only patients seeking services or engaged in care at an existing outpatient program at MGH (the Addiction Recovery Management Service) are eligible for participation.
Young adults with substance use disorder (SUD) commonly experience co-occurring emotional distress in the form of affective/emotional disorders (i.e. anxiety, depressive, and related disorders) and self-injurious thoughts and behaviors (SITBs). Based on the conceptualization of emotion dysregulation as a transdiagnostic treatment target, the current study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to target core psychopathological processes related to emotion dysregulation that underlie SITBs and emotional disorder pathology. Given its transdiagnostic format, the UP has the potential to address comorbidity among the emotional disorders (and other functionally similar problems such as SUDs) simultaneously and more comprehensively than single-diagnosis treatments.
Patients seeking services or currently engaged in care at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders (the MGH Addiction Recovery Management Service) are eligible for this study. Participants will be randomized 2:1 to receive either UP + TAU or TAU alone. The adjunctive UP intervention consists of 16 twice-weekly group sessions (delivered over an 8-week period) designed to deliver transdiagnostic, emotion-focused CBT strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unified Protocol + Treatment As Usual | Experimental | Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
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| Treatment As Usual Alone | Active Comparator | Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unified Protocol (UP) | Behavioral | The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Adding UP Group Intervention to TAU | Participants in the UP condition will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment to assess acceptability of and satisfaction with the experimental intervention. Range of the scale is 8 (minimum) to 32 (maximum), with higher scores indicating greater levels of satisfaction with treatment received. | At the end of the 8-week treatment period |
| Feasibility of Adding UP Group Intervention to TAU | Percentage of participants who dropout from treatment during the 8 week study period in the UP+TAU condition will be compared to the percentage of those who drop out from treatment in the TAU condition. | 8-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| OASIS | Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety. | At the end of the 8-week treatment period |
| Depressive Symptoms Scale (ODSIS) |
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Only patients seeking services or currently engaged in care at the MGH Addiction Recovery Management Service are eligible for this study.
Inclusion Criteria:
Young adults ages 18 to 26, inclusive
English language proficiency
Ability to provide written, informed consent
Ability to attend in-person, outpatient sessions
Has provided consent to receive or is currently undergoing treatment at the MGH Addiction Recovery Management Service
Documented DSM-5 SUD diagnosis (limited to alcohol use disorder; cannabis use disorder; phencyclidine or other hallucinogen use disorder; inhalant use disorder, opioid use disorder; sedative, hypnotic, or anxiolytic use disorder; stimulant use disorder; other (or unknown) SUD)
Current elevated emotional distress, as evidenced by any one of the following:
Not expected to require inpatient level of care within the next two weeks (as judged clinically)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eden Evins, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Addiction Recovery Management Service | Boston | Massachusetts | 02114 | United States |
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Participants were randomized in cohorts of 5. Thus, participants underwent a "waiting to be randomized" period from enrollment until the date they were randomized.
9 participants were excluded between the point of enrollment to randomization; 8 due to not meeting inclusion criteria, and 1 withdrawn by the PI while waiting to be randomized.
Participants were recruited from November 2017 to July 2019 from an outpatient treatment program for adolescents and young adults with substance use disorders.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unified Protocol + Treatment As Usual | Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies. Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2019 | Sep 29, 2020 |
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| Treatment as Usual (TAU) | Other | Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
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Measured with the Overall Depression Severity and Impairment Scale (ODSIS) at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of depressive symptoms.
| At the end of the 8-week treatment period |
| Suicidal Ideation | Measured with the Beck Scale for Suicidal Ideation (BSI) at post-treatment. Total scores range from 0-38; higher scores indicate higher levels of suicidal ideation. | At the end of the 8-week treatment period |
| Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month | Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment. | At the end of the 8-week treatment period |
| Commitment to Sobriety | Measured with the Commitment to Sobriety Scale (CSS) at post-treatment. Total scores range from 5-30; higher scores indicate higher levels of commitment to sobriety. | At the end of the 8-week treatment period |
| Substance Craving | Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving. | At the end of the 8-week treatment period |
| Percentage of Past 30 Days Abstinent From Substances | Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment. | At the end of the 8-week treatment period |
| FG001 | Treatment As Usual Alone | Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Unified Protocol + Treatment As Usual | Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies. Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
| BG001 | Treatment As Usual Alone | Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ODSIS | Overall Depression Severity and Impairment Scale Total scores range from 0-20 with higher scores indicating more severe depression | Mean | Standard Deviation | units on a scale |
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| PHQ-9 | Patient Health Questionnaire-9 Total score ranges from 0-27, with higher scores indicating more severe depression | Mean | Standard Deviation | units on a scale |
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| GAD-7 | Generalized Anxiety Disorder-7 Total scores range from 0-21, with higher scores indicating more severe anxiety | Mean | Standard Deviation | units on a scale |
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| OASIS | Overall Anxiety Severity and Impairment Scale Total scores range from 0-20, with higher scores indicating more severe anxiety | Mean | Standard Deviation | units on a scale |
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| BSS | Beck Scale for Suicidal Ideation Total scores range from 0-38, with higher scores indicating more severe suicidal ideation | Mean | Standard Deviation | units on a scale |
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| CSS | Commitment to Sobriety Scale Total scores range from 5-30, with higher scores indicating greater commitment to sobriety | Mean | Standard Deviation | units on a scale |
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| Craving Scale | Craving Scale Total scores range from 0-27, with higher scores indicating more severe craving | Mean | Standard Deviation | units on a scale |
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| Past 30-day PDA | Percent of last 30 days abstinent Scores range from 0-100%, with higher scores indicating more days abstinent | Mean | Standard Deviation | percentage of days abstinent |
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| Past-month NSSI (SITBI) | Count of participants with at least one day in which they engaged in NSSI over the past month (from Self-Injurious Thoughts and Behaviors Interview) | Count of Participants | Participants |
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| Past-month SI (SITBI) | Count of participants with at least one day of suicidal ideation in the past month (from Self-Injurious Thoughts and Behaviors Interview) | Count of Participants | Participants |
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| 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 | Acceptability of Adding UP Group Intervention to TAU | Participants in the UP condition will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment to assess acceptability of and satisfaction with the experimental intervention. Range of the scale is 8 (minimum) to 32 (maximum), with higher scores indicating greater levels of satisfaction with treatment received. | 13 participants who attended at least 1 Unified Protocol session completed the CSQ-8. | Posted | Mean | Standard Deviation | units on a scale | At the end of the 8-week treatment period |
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| Primary | Feasibility of Adding UP Group Intervention to TAU | Percentage of participants who dropout from treatment during the 8 week study period in the UP+TAU condition will be compared to the percentage of those who drop out from treatment in the TAU condition. | Total numbers randomized to each condition | Posted | Count of Participants | Participants | 8-week treatment period |
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| Secondary | OASIS | Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety. | Participants who completed the OASIS at the post-treatment assessment (means at post-treatment reported below). | Posted | Mean | Standard Deviation | units on a scale | At the end of the 8-week treatment period |
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| Secondary | Depressive Symptoms Scale (ODSIS) | Measured with the Overall Depression Severity and Impairment Scale (ODSIS) at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of depressive symptoms. | Participants who completed the post-treatment assessments (means reported below). | Posted | Mean | Standard Deviation | score on a scale | At the end of the 8-week treatment period |
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| Secondary | Suicidal Ideation | Measured with the Beck Scale for Suicidal Ideation (BSI) at post-treatment. Total scores range from 0-38; higher scores indicate higher levels of suicidal ideation. | Participants who completed the post-treatment assessment (means reported below). | Posted | Mean | Standard Deviation | score on a scale | At the end of the 8-week treatment period |
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| Secondary | Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month | Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment. | Posted | Count of Participants | Participants | At the end of the 8-week treatment period |
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| Secondary | Commitment to Sobriety | Measured with the Commitment to Sobriety Scale (CSS) at post-treatment. Total scores range from 5-30; higher scores indicate higher levels of commitment to sobriety. | Participants who completed the post-treatment assessment (means reported below). | Posted | Mean | Standard Deviation | score on a scale | At the end of the 8-week treatment period |
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| Secondary | Substance Craving | Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving. | Participants who completed the post-treatment assessment (means reported below). | Posted | Mean | Standard Deviation | score on a scale | At the end of the 8-week treatment period |
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| Secondary | Percentage of Past 30 Days Abstinent From Substances | Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment. | Participants who completed the post-treatment assessment (means presented below). | Posted | Mean | Standard Deviation | percentage of past 30 days abstinent | At the end of the 8-week treatment period |
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Adverse event data were collected during the active study period (baseline to post-treatment assessment). Because the "waiting be be randomized" period (between baseline and date of randomization) varied across participants, the total study period lasted between 2 and 6 months.
Adverse events were collected at the mid- and post-treatment assessments, which happened at 4 and 8 weeks, respectively, after the date of randomization, via systematic assessment. Non-systematic assessment was also used to collect information about adverse events by reviewing participants' electronic health records weekly during the study period.
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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 | Unified Protocol + Treatment As Usual | Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Unified Protocol (UP): The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies. Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. | 0 | 29 | 3 | 29 | 13 | 29 |
| EG001 | Treatment As Usual Alone | Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. Treatment as Usual (TAU): Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders. | 0 | 18 | 4 | 18 | 8 | 18 |
| EG002 | Not Randomized | Participants in this arm were enrolled and completed the baseline visit but never randomized. | 0 | 9 | 2 | 9 | 0 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Relapse to substances (resulting in inpatient treatment) | Psychiatric disorders | Systematic Assessment |
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| Relapse to substances (resulting in emergency department visit)) | Psychiatric disorders | Systematic Assessment |
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| Active suicidal ideation with plan (resulting in inpatient treatment) | Psychiatric disorders | Systematic Assessment |
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| Active suicidal ideation with plan (without inpatient treatment) | Psychiatric disorders | Systematic Assessment |
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| Increase in psychotic symptoms (resulting in inpatient treatment) | Psychiatric disorders | Systematic Assessment |
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| Pseudoseizure (resulting in emergency department visit) | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Relapse to substances (without medical attention) | Psychiatric disorders | Systematic Assessment |
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| Substance use resulting in emergency department visit (not hospitalized) | Psychiatric disorders | Systematic Assessment |
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| Non-fatal overdose (without seeking medical attention) | Psychiatric disorders | Systematic Assessment |
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| Entered intensive outpatient program for substance use | Psychiatric disorders | Systematic Assessment |
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| Increased suicidal ideation or urges to engage in nonsuicidal self-injury | Psychiatric disorders | Systematic Assessment |
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| Increased depressive symptoms | Psychiatric disorders | Systematic Assessment |
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| Increased anxiety-related symptoms | Psychiatric disorders | Systematic Assessment |
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| Cognitively impaired in context of increased anxiety/substance use (resulting in emergency departmen | Psychiatric disorders | Systematic Assessment |
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| Increased manic symptoms | Psychiatric disorders | Systematic Assessment |
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| Increased restlessness | Psychiatric disorders | Systematic Assessment |
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| Increased binge eating | Psychiatric disorders | Systematic Assessment |
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| Increased stress (related to study group participation) | Psychiatric disorders | Systematic Assessment |
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| Increased stress (not study-related) | Psychiatric disorders | Systematic Assessment |
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| Adverse reaction to non-study medication | General disorders | Systematic Assessment |
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| Flu | General disorders | Systematic Assessment |
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| Headaches/migraine | General disorders | Systematic Assessment |
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| Weight gain | General disorders | Systematic Assessment |
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| Chest tightness attributed to onset of electronic cigarette use | General disorders | Systematic Assessment |
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| Head injury | General disorders | Systematic Assessment |
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| Contracted STD | Infections and infestations | Systematic Assessment |
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| Sleep apnea symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Asthma symptoms | General disorders | Systematic Assessment |
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| Abdominal pain/nausea/vomiting (in context of early withdrawal) | General disorders | Systematic Assessment |
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Due to dropout, there were small numbers of participants analyzed at post-treatment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kate Bentley | Massachusetts General Hospital/Harvard Medical School | 617-724-7741 | kbentley@mgh.harvard.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 5, 2019 | Mar 5, 2021 | Prot_001.pdf |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D059020 | Suicidal Ideation |
| D016728 | Self-Injurious Behavior |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D013405 | Suicide |
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| ID | Term |
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| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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