Study: NCT03315208

Adverse event: Relapse to substances (resulting in inpatient treatment)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: Active suicidal ideation with plan (without inpatient treatment)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Substance use resulting in emergency department visit (not hospitalized)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Non-fatal overdose (without seeking medical attention)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Increased suicidal ideation or urges to engage in nonsuicidal self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: Increased depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 29 at risk

Adverse event: Increased anxiety-related symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: Cognitively impaired in context of increased anxiety/substance use (resulting in emergency departmen
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Increased manic symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Increased restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Increased stress (related to study group participation)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 29 at risk

Adverse event: Influenza
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Headaches/migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Chest tightness attributed to onset of electronic cigarette use
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Head injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abdominal pain/nausea/vomiting (in context of early withdrawal)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Relapse to substances (resulting in inpatient treatment)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Relapse to substances (resulting in emergency department visit))
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Active suicidal ideation with plan (resulting in inpatient treatment)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Increase in psychotic symptoms (resulting in inpatient treatment)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Relapse to substances (without medical attention)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Entered intensive outpatient program for substance use
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Increased suicidal ideation or urges to engage in nonsuicidal self-injury
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

Adverse event: Increased depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

Adverse event: Increased anxiety-related symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 18 at risk

Adverse event: Increased binge eating
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Increased stress (not study-related)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Adverse reaction to non-study medication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headaches/migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Contracted STD
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Sleep apnea symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Asthma symptoms
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Active suicidal ideation with plan (resulting in inpatient treatment)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pseudoseizure (resulting in emergency department visit)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk