Study: NCT03818191

Adverse event: ER/Hospital visit for suicidal ideation, intoxication, or alcohol withdrawal
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 184 at risk

Adverse event: Loss of sexual interest or problems with erection or achieving orgasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 184 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 184 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 184 at risk

Adverse event: Jaw and Ear Pain, Broken Jaw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 184 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 184 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 184 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Side effects of Lexapro
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 184 at risk

Adverse event: GI virus, upset, Diarrhea, gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 184 at risk

Adverse event: Smashed Finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Muscle pain/feeling achy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 184 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 184 at risk

Adverse event: Urinary symptoms - frequency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 184 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 184 at risk

Adverse event: Increased score in suicidal thoughts question
Serious: no
Organ System: Psychiatric disorders
Notes: Patient Health Questionnaire-9 (PHQ-9) individual score of suicidal thoughts question was non-zero from previous assessments.
Frequency: 4 affected / 184 at risk

Adverse event: Fainting during blood draw
Serious: no
Organ System: General disorders
Frequency: 2 affected / 184 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 184 at risk

Adverse event: Edema/bloating after starting meds & increased on full dose
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Gabapentin started same day as study med
Frequency: 1 affected / 184 at risk

Adverse event: Altered mental status due to hepatic encephalopathy w/o coma
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 184 at risk

Adverse event: Skin Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 184 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 184 at risk

Adverse event: Relapse - alcohol consumption
Serious: no
Organ System: Psychiatric disorders
Notes: Reported from subjects who remained engaged in study participation.
Frequency: 4 affected / 184 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 184 at risk

Adverse event: Face swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Constipation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 184 at risk

Adverse event: Possible Acamprosate side effects
Serious: no
Organ System: Product Issues
Notes: sensitive gums, nausea, headache, too hot or too cold, loss of appetite, inflammation in the knee, overall tiredness
Frequency: 1 affected / 184 at risk

Adverse event: ED visit for tooth pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 184 at risk

Adverse event: Demyelination
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: More than likely it's MS not sure at this time
Frequency: 1 affected / 184 at risk

Adverse event: Distress from symptoms with request that study psychiatrist contact them
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 184 at risk

Adverse event: Shoulder injury/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: Chronic Knee injury (history of)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requires surgery after discharge
Frequency: 1 affected / 184 at risk

Adverse event: Emotional upset
Serious: no
Organ System: Psychiatric disorders
Notes: Triggered by reviewing drinking history details and marijuana use questions from the PRISM \& TLFB assessments
Frequency: 2 affected / 184 at risk

Adverse event: Patient Health Information (PHI) shared with non-study member
Serious: no
Organ System: Social circumstances
Notes: Email w/PHI sent to HBFF employee not IRB approved - notified employee \& had it deleted before opening
Frequency: 1 affected / 184 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requires surgery
Frequency: 1 affected / 184 at risk

Adverse event: Bruise around left eye
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 184 at risk

Adverse event: ER/Hospital visit for suicidal ideation, intoxication, or alcohol withdrawal
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 104 at risk

Adverse event: Loss of sexual interest or problems with erection or achieving orgasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 104 at risk

Adverse event: Prolonged QT interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 104 at risk

Adverse event: Cold/Flu
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 104 at risk

Adverse event: Jaw and Ear Pain, Broken Jaw
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 104 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 104 at risk

Adverse event: Seizure - no loss of consciousness
Serious: no
Organ System: Nervous system disorders
Notes: Patient with history of seizure
Frequency: 1 affected / 104 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Physical assault
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 104 at risk

Adverse event: GI virus, upset, Diarrhea, gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 104 at risk

Adverse event: Muscle pain/feeling achy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 104 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 104 at risk

Adverse event: Depression, increased depressive thoughts and feelings
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 104 at risk

Adverse event: Urinary symptoms - frequency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 104 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 104 at risk

Adverse event: Decreased energy
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 104 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 104 at risk

Adverse event: Increased score in suicidal thoughts question
Serious: no
Organ System: Psychiatric disorders
Notes: Patient Health Questionnaire-9 (PHQ-9) individual score of suicidal thoughts question was non-zero from previous assessments.
Frequency: 2 affected / 104 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Relapse - alcohol consumption
Serious: no
Organ System: Psychiatric disorders
Notes: Reported from subjects who remained engaged in study participation.
Frequency: 4 affected / 104 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Piercing infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Pt found unconscious & unresponsive 40-45 minutes after blood draw
Serious: no
Organ System: Nervous system disorders
Notes: consciousness returned and had 30 min of observation
Frequency: 1 affected / 104 at risk

Adverse event: Distress from symptoms with request that study psychiatrist contact them
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk

Adverse event: Shoulder injury/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: COVID 19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Mouth injury and spitting blood
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: Irritation, feelings of crabbiness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk

Adverse event: Panic attack with disassociation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk