Trial Outcomes & Findings for Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users (NCT NCT02445339)
NCT ID: NCT02445339
Last Updated: 2022-05-11
Results Overview
Self-reported
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Month 3
Results posted on
2022-05-11
Participant Flow
Participant milestones
| Measure |
Intervention Arm: XR-NTX+CM
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
Reasons for withdrawal
| Measure |
Intervention Arm: XR-NTX+CM
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
15
|
Baseline Characteristics
Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users
Baseline characteristics by cohort
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
55 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 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
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 3Self-reported
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Number of Heavy Drinking Days
|
62 days
Standard Deviation 9.4
|
0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Month 6Self-reported
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Number of Heavy Drinking Days
|
32 days
Standard Deviation 9.1
|
25 days
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Month 12Self-reported
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Number of Heavy Drinking Days
|
0 days
Standard Deviation 0
|
37 days
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Month 3SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use.
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Short Inventory of Problems Related to Alcohol (SIP-2R) Score
|
25.4 score on a scale
Standard Deviation 10.6
|
24.9 score on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Month 6SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use.
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Short Inventory of Problems Related to Alcohol (SIP-2R) Score
|
20.8 score on a scale
Standard Deviation 14.6
|
25.3 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Month 12SIP-2R is a measure for assessing recent adverse consequences associated with alcohol use. SIP-2R consists of 15 events that are scored from 0 (never) to 3 (daily or almost daily). The total score range is 0-45; the higher the score, the more problems related to alcohol use.
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Short Inventory of Problems Related to Alcohol (SIP-2R) Score
|
13.1 score on a scale
Standard Deviation 11
|
17.1 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Month 3Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Carbohydrate-deficient Transferrin (CDT) Levels
|
5.4 %CDT
Standard Deviation 4.6
|
2.8 %CDT
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Carbohydrate-deficient Transferrin (CDT) Levels
|
3.5 %CDT
Standard Deviation 3.4
|
4.7 %CDT
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Carbohydrate-deficient Transferrin (CDT) Levels
|
2.6 %CDT
Standard Deviation 2.1
|
3.7 %CDT
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Month 3Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Gamma-glutamyl Transferase (GGT) Levels
|
197.8 units/liter
Standard Deviation 290
|
107.8 units/liter
Standard Deviation 136.8
|
SECONDARY outcome
Timeframe: Month 6Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Gamma-glutamyl Transferase (GGT) Levels
|
154.8 units/liter
Standard Deviation 305.6
|
146.8 units/liter
Standard Deviation 193.2
|
SECONDARY outcome
Timeframe: Month 12Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
Gamma-glutamyl Transferase (GGT) Levels
|
111.8 units/liter
Standard Deviation 178.2
|
109.3 units/liter
Standard Deviation 139
|
SECONDARY outcome
Timeframe: Month 3EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state).
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
EuroQoL-5 Dimensions (EQ-5D) Score
|
67.1 score on a scale
Standard Deviation 25.2
|
56.1 score on a scale
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: Month 6EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state).
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
EuroQoL-5 Dimensions (EQ-5D) Score
|
70.4 score on a scale
Standard Deviation 19.8
|
68.8 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Month 12EQ-5D is a standardized measure of health-related quality of life. A visual analogue scale is used to record an individual's valuation of defined EQ-5D profiles. The total score range is 0-100; the higher the score, the better the health state (0=worst imaginable health state, 100=best imaginable health state).
Outcome measures
| Measure |
Intervention Arm: XR-NTX+CM
n=13 Participants
XR-NTX+CM (Extended Release Naltrexone + Care Management)
XR-NTX+CM (Extended-Release Naltrexone plus Care Management): The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
|
Standard Care Arm
n=10 Participants
Standard Care/Alcohol-Medical Management (MM) Only
|
|---|---|---|
|
EuroQoL-5 Dimensions (EQ-5D) Score
|
77.6 score on a scale
Standard Deviation 14.1
|
56.7 score on a scale
Standard Deviation 23.9
|
Adverse Events
Intervention Arm: XR-NTX+CM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place