Trial Outcomes & Findings for Alcohol Disorder hOsPital Treatment Trial (NCT NCT02478489)
NCT ID: NCT02478489
Last Updated: 2021-06-29
Results Overview
The primary alcohol use outcome will be change in percent heavy drinking days (%HDDs) from baseline to 3 month follow-up. %HDDs out of the past 30 days is assessed using the Timeline Follow-Back. %HDDs is the most likely (and most sensitive) to be affected by NTX and is clinically important (any reduction means less risk of harm). We chose self-report because biological testing is not sufficiently valid for detecting drinking levels and changes of clinical importance. The self-report tool is valid, particularly so when staff are well trained, and when the context for the subject is: they are informed they are being tested for consumption (breath alcohol and carbohydrate deficient transferrin (CDT), there are no consequences related to consumption levels, and that results are being recorded confidentially.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
248 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2021-06-29
Participant Flow
Participant milestones
| Measure |
Extended-release Injectable Naltrexone (XR-NTX)
Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
|
Oral Naltrexone (PO-NTX)
Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Oral naltrexone (PO-NTX): oral naltrexone
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
125
|
|
Overall Study
COMPLETED
|
108
|
109
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alcohol Disorder hOsPital Treatment Trial
Baseline characteristics by cohort
| Measure |
Extended-release Injectable Naltrexone (XR-NTX)
n=123 Participants
Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
|
Oral Naltrexone (PO-NTX)
n=125 Participants
Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Oral naltrexone (PO-NTX): oral naltrexone
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
49.4 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
49.4 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
61 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Percent heavy drinking days over the past 30 days assessed at baseline by Timeline Followback
|
70.7 Percent heavy drinking days of past 30
STANDARD_DEVIATION 31.5 • n=5 Participants
|
66.7 Percent heavy drinking days of past 30
STANDARD_DEVIATION 31.5 • n=7 Participants
|
68.7 Percent heavy drinking days of past 30
STANDARD_DEVIATION 31.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Analysis population includes those who completed the 3 month follow-up assessment. Population does not match baseline sample due to attrition / loss to follow-up.
The primary alcohol use outcome will be change in percent heavy drinking days (%HDDs) from baseline to 3 month follow-up. %HDDs out of the past 30 days is assessed using the Timeline Follow-Back. %HDDs is the most likely (and most sensitive) to be affected by NTX and is clinically important (any reduction means less risk of harm). We chose self-report because biological testing is not sufficiently valid for detecting drinking levels and changes of clinical importance. The self-report tool is valid, particularly so when staff are well trained, and when the context for the subject is: they are informed they are being tested for consumption (breath alcohol and carbohydrate deficient transferrin (CDT), there are no consequences related to consumption levels, and that results are being recorded confidentially.
Outcome measures
| Measure |
Extended-release Injectable Naltrexone (XR-NTX)
n=108 Participants
Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
|
Oral Naltrexone (PO-NTX)
n=109 Participants
Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Oral naltrexone (PO-NTX): oral naltrexone
|
|---|---|---|
|
Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back
|
-46.4 change in percent heavy drinking days
Standard Deviation 38.5
|
-38.4 change in percent heavy drinking days
Standard Deviation 43.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Analysis population includes those who completed the 3 month follow-up assessment. Population does not match baseline sample due to attrition / loss to follow-up.
Any acute hospital utilization (emergency department visit or inpatient stay) over the past 90 days assessed at 3-month follow-up by the Form 90. Self-report for short-term high impact, memorable health utilization such as emergency and hospital stays is valid and can measure utilization at any site. Using the clinical data warehouse at one site (Boston Medical Center (BMC)) and statewide data, we will compare self-report to the utilization databases. But, self-report data will remain primary, with databases used to provide a descriptive frame of reference.
Outcome measures
| Measure |
Extended-release Injectable Naltrexone (XR-NTX)
n=108 Participants
Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
|
Oral Naltrexone (PO-NTX)
n=109 Participants
Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Oral naltrexone (PO-NTX): oral naltrexone
|
|---|---|---|
|
Acute Care Hospital Utilization
Any acute care hospital utilization (emergency department visit or inpatient stay)
|
66 Participants
|
59 Participants
|
|
Acute Care Hospital Utilization
No acute care hospital utilization (emergency department visit or inpatient stay)
|
42 Participants
|
50 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1, 2 and 3 monthsHigh adherence to XR-NTX will be defined as administration of XR-NTX by the study nurse 3 times. Medium adherence will be defined as 1 or 2 injections. For PO-NTX, high adherence will be defined as participant self-report of taking PO-NTX for 90 out of the past 90 days at the 3 month study visit, and medium adherence as participant self-report of taking PO-NTX for 30-89 out of the past 90 days at the 3 month study visit (Form 90). We will also assess the presence of detectable beta-naltrexol to confirm reports of recent pill taking.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsAlcohol consequences over the past 3 months will be measured by collecting participant self-report data via the Short Inventory of Problems (SIP-2R) at 3-month follow-up. The SIP-2R is a validated 15-item measure for assessing recent adverse consequences associated with alcohol use.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsAlcohol use disorder-related treatment utilization over the past 90 days assessed at 3-month follow-up by the Form 90. Using the clinical data warehouse at one site (Boston Medical Center (BMC)) and statewide data, we will compare self-report to the utilization databases. But, self-report data will remain primary, with databases used to provide a descriptive frame of reference.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 and 12 monthsHealthcare utilization cost data will be collected via the Form 90 for self-reported outpatient and emergency visits, hospitalizations, and specialty addiction treatment. Utilization episodes will be converted to costs by use of Medicare relative value units (RVUs) for acute inpatient care, Resource Based Relative Value System (RBRVS) units for Medicare reimbursement of outpatient visits, and the average daily rate for long-term care.
Outcome measures
Outcome data not reported
Adverse Events
Extended-release Injectable Naltrexone (XR-NTX)
Serious events: 43 serious events
Other events: 59 other events
Deaths: 2 deaths
Oral Naltrexone (PO-NTX)
Serious events: 43 serious events
Other events: 39 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Extended-release Injectable Naltrexone (XR-NTX)
n=123 participants at risk
Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
|
Oral Naltrexone (PO-NTX)
n=125 participants at risk
Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Oral naltrexone (PO-NTX): oral naltrexone
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
3.2%
4/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Hepatobiliary disorders
Acute Cholecystitis
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Alcohol Withdrawal
|
4.9%
6/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
8.0%
10/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Altered Mental Status
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Musculoskeletal and connective tissue disorders
Ankle Fracture
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Musculoskeletal and connective tissue disorders
Ankle Pain
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Basal Ganglia Hemorrage
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Chest Pain
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
3.2%
4/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
3.3%
4/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Congestive Heart Failure
|
1.6%
2/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Infections and infestations
Coronavirus (COVID-19)
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
General disorders
Death
|
1.6%
2/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
2.4%
3/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Dizziness
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Gastrointestinal disorders
Epigastric Pain
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
2/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
General disorders
Fatigue
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Heart Failure
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Hypertension
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Hypotension
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Skin and subcutaneous tissue disorders
Injection Site Abscess
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
—
0/0 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Injury, poisoning and procedural complications
Intoxication
|
2.4%
3/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Surgical and medical procedures
Laparoscopic Cholecystectomy
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Musculoskeletal and connective tissue disorders
Left Hand Tenosynovitis
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Pain
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Infections and infestations
Osteomylelitis of Toe
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
4/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Psychiatric Hospitalization
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Vascular disorders
Pulmonary embolism
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Gastrointestinal disorders
Rectal Bleeding
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Seeking Detox
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Seizure
|
4.1%
5/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.4%
3/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Subdural Hematoma
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
1.6%
2/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Psychiatric disorders
Suicide Attempt
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Cardiac disorders
Syncope
|
2.4%
3/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Nervous system disorders
Thoracic Osteomyelitis
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Injury, poisoning and procedural complications
Traumatic Injury
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.80%
1/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
2.4%
3/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
General disorders
Weakness
|
0.81%
1/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
0.00%
0/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
Other adverse events
| Measure |
Extended-release Injectable Naltrexone (XR-NTX)
n=123 participants at risk
Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Extended-release injectable naltrexone (XR-NTX): injectable naltrexone
|
Oral Naltrexone (PO-NTX)
n=125 participants at risk
Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Oral naltrexone (PO-NTX): oral naltrexone
|
|---|---|---|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
15.4%
19/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
25.6%
32/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Skin and subcutaneous tissue disorders
Injection Site Discomfort
|
29.3%
36/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
—
0/0 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
|
Injury, poisoning and procedural complications
Intoxication
|
13.0%
16/123 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
9.6%
12/125 • Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
|
Additional Information
Richard Saitz, MD MPH
Boston University School of Public Health and School of Medicine
Phone: (617) 358-1343
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place