Study: NCT00430482

Adverse event: Skin ulcer
Serious: yes
Organ System: General disorders
Notes: A participant was hospitalized for a chronic foot ulcer problem. Hospitalization lasted for two weeks, but the participant still completed his study visits. The medical event was judged to be in no way related to the study procedures.
Frequency: 1 affected / 41 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant was partially hospitalized for a sprained left ankle. Hospitalization was required due to patient's perceived medical risk. This event was judged to be unrelated to study procedures.
Frequency: 1 affected / 41 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant was hospitalized due to a kidney infection secondary to an untreated urinary tract infection. This event was judged to be unrelated to study procedures.
Frequency: 1 affected / 41 at risk

Adverse event: Groin Injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant was hospitalized due to problematic functioning in the patient's groin area.
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was hospitalized for four days due to pneumonia, inflamed intestines, and high blood pressure (as per patient report). Investigators learned about the SAE after patient has been discharged.
Frequency: 1 affected / 41 at risk

Adverse event: Respiratory Problems
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization due to low blood pressure and respiratory problems.
Frequency: 1 affected / 41 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant reported being admitted to a residential substance abuse treatment facility for detoxification. The patient remained at the facility for 30 days. The admission to the facility occurred prior to randomization to treatment condition.
Frequency: 1 affected / 41 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Inpatient psychiatry hospitalization for six days due to symptoms of depression. Patient denied suicidal ideation, and stated that hospitalization was required for emergency medication management.
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization for seven days due to a bout of pneumonia.
Frequency: 1 affected / 41 at risk

Adverse event: Hospitalization for Chronic Health Concerns
Serious: yes
Organ System: General disorders
Notes: Hospitalization for four days. Participant had chronic health concerns and completed the active treatment phase of the study and had been discharged from the clinic before hospitalization. This SAE was unrelated to study procedures.
Frequency: 1 affected / 41 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant voluntarily entered an inpatient unit for 5 days for the detoxification of benzodiazepines. Upon discharge from the detoxification facility, the participant resumed regular dosing at the methadone clinic and resumed study procedures.
Frequency: 1 affected / 41 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Participant was hospitalized for several days for a kidney stone. Participant was released and resumed dosing at the clinic and resumed study procedures.
Frequency: 1 affected / 41 at risk

Adverse event: Stress fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant was admitted to the ER secondary to bruised ribs and hairline fracture secondary to falling from a chair.
Frequency: 1 affected / 37 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was hospitalized secondary to "oversedation." Patient subsequently sought out inpatient detox, complaining of overprescription of a benzodiazepine medication and acute psychiatric symptoms.
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization due to pneumonia resulting from chronic condition that compromises immune functioning.
Frequency: 1 affected / 37 at risk

Adverse event: High Glucose Levels
Serious: yes
Organ System: Endocrine disorders
Notes: Hospitalization due to extremely high glucose levels resulting from diabetes.
Frequency: 1 affected / 37 at risk

Adverse event: Blood Clot
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospitalization for five days due to formation of a blood clot around the central artery, where a central IV had previously been placed. Patient was treated by hospital staff with prescribed self-injection and a blood thinner.
Frequency: 1 affected / 37 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Notes: Hospitalization for two to three days for an infection and unspecified chronic health problems. Participant resumed and completed study procedures upon discharge from the hospital. This event was unrelated to study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant voluntarily entered an inpatient unit for five days for the detoxification of benzodiazepines. Participant resumed and completed study procedures upon discharge from the hospital. This event was unrelated to study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant was hospitalized for detoxification and mental health problems. This participant was subsequently discharged from the methadone clinic and did not complete study procedures. This event was unrelated to study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant reported losing housing, and reported suicidal ideation to a (non-study) counselor to obtain emergency housing. Participant was at this unit for several days, yet came to the methadone clinic as part of scheduled study involvement.
Frequency: 1 affected / 37 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant reported serious psychological distress to study staff. After assessing suicidal ideation, it was decided that this situation warranted intervention.The participant was then independently assessed and hospitalization by clinic staff.
Frequency: 1 affected / 37 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant voluntarily entered an inpatient detoxification unit for the detoxification of heroin and benzodiazepines. Upon discharge from the detoxification facility, the participant resumed regular study involvement and completed study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: The investigators were notified that a participant was hospitalized again for suicidal ideation. The clinic staff independently assessed the patient and deemed that hospitalization was necessary.
Frequency: 1 affected / 37 at risk

Adverse event: Detoxification
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant voluntarily entered an inpatient detoxification unit. Upon discharge from the detoxification facility, the participant resumed regular study involvement.
Frequency: 1 affected / 37 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was hospitalized for 7 days for pneumonia. This participant has a history of chronic health problems, which worsened to the point that IV antibiotics were needed. Participant resumed dosing at the clinic and resumed study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant was hospitalized for five days for various medical problems related to a stab wound, including several blood transfusions. Participant resumed dosing at the clinic and resumed study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Participant hospitalized for dehydration. Following discharged, participant resumed dosing at the clinic and continued with study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Wound treatment
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Participant was hospitalized overnight for 3 days. Participant was beaten over the head and received treatment for his wounds at this hospital. Participant resumed dosing at the clinic and continued study procedures.
Frequency: 1 affected / 37 at risk

Adverse event: Hospitalization for Chronic Health Concerns
Serious: yes
Organ System: General disorders
Notes: Hospitalization for four days. Participant had chronic health concerns and completed the active treatment phase of the study and had been discharged from the clinic before hospitalization.
Frequency: 1 affected / 37 at risk