Trial Outcomes & Findings for Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care (NCT NCT01893827)
NCT ID: NCT01893827
Last Updated: 2020-06-16
Results Overview
Percentage of participants who had the following number of drinks (≤2 drinks/day, men; ≤1 drink/day, women; and ≤2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
237 participants
Primary outcome timeframe
4-24 weeks
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
XR-NTX
Xr-NTX 380mg IM injection monthly x 6 months
XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
|
Oral Naltrexone
Oral naltrexone 50mg/day x 6 months
Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
120
|
|
Overall Study
COMPLETED
|
98
|
94
|
|
Overall Study
NOT COMPLETED
|
19
|
26
|
Reasons for withdrawal
| Measure |
XR-NTX
Xr-NTX 380mg IM injection monthly x 6 months
XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
|
Oral Naltrexone
Oral naltrexone 50mg/day x 6 months
Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
26
|
Baseline Characteristics
Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
Baseline characteristics by cohort
| Measure |
XR-NTX
n=117 Participants
Xr-NTX 380mg IM injection monthly x 6 months
XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
|
Oral Naltrexone
n=120 Participants
Oral naltrexone 50mg/day x 6 months
Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
49 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
48 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
186 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=5 Participants
|
120 participants
n=7 Participants
|
237 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-24 weeksPercentage of participants who had the following number of drinks (≤2 drinks/day, men; ≤1 drink/day, women; and ≤2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence.
Outcome measures
| Measure |
XR-NTX
n=117 Participants
Xr-NTX 380mg IM injection monthly x 6 months
XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
|
Oral Naltrexone
n=120 Participants
Oral naltrexone 50mg/day x 6 months
Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months.
|
|---|---|---|
|
Percentage of Participants With Alcohol Abstinence or Moderate Drinking
|
29 percentage of participants
|
23 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-24 weeksTo estimate the incremental cost-effectiveness of XR-NTX vs. O-NTX, both in conjunction with primary care-based medical management. Economic data will be derived primarily from the Economic Form 90, Non-Study Medical Service and electronic medical records assessments, EQ-5D (functional status), and a cost survey or standardized question querying patient reports of specific non-medical related costs (including lost/gained work, lost/gained dependent care, transportation costs, arrests, motor vehicle accidents) collected at baseline and at week 10, 18, 26, and 48 assessments.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-24 weeksTo identify patient-level characteristics (gender, ethnicity, pre-treatment abstinence, voluntary specialty alcohol treatment and Alcoholics Anonymous involvement) associated with effectiveness in both arms. Baseline Demographic and Timeline Follow-Back and in-study Non-Study Medical Service questionnaires will characterized these patient-level variables.
Outcome measures
Outcome data not reported
Adverse Events
XR-NTX
Serious events: 22 serious events
Other events: 19 other events
Deaths: 2 deaths
Oral Naltrexone
Serious events: 20 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XR-NTX
n=117 participants at risk
Xr-NTX 380mg IM injection monthly x 6 months
XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
|
Oral Naltrexone
n=120 participants at risk
Oral naltrexone 50mg/day x 6 months
Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months.
|
|---|---|---|
|
General disorders
Hospitalization
|
18.8%
22/117 • 1 year
|
16.7%
20/120 • 1 year
|
|
General disorders
Death; Stage IV Cancer
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Death; cardiac arrest
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
Other adverse events
| Measure |
XR-NTX
n=117 participants at risk
Xr-NTX 380mg IM injection monthly x 6 months
XR-NTX (Extended-Release Naltrexone): 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
|
Oral Naltrexone
n=120 participants at risk
Oral naltrexone 50mg/day x 6 months
Oral Naltrexone (O-NTX): 50mg pill form of naltrexone taken 1x/day for 6 months.
|
|---|---|---|
|
General disorders
ER Visit
|
16.2%
19/117 • 1 year
|
15.0%
18/120 • 1 year
|
|
Infections and infestations
Scrotal Infection
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Anosmia
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Decreased Libido
|
1.7%
2/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
Psychiatric disorders
Depressed Mood
|
0.85%
1/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
Heat Rash
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
Immune system disorders
Hep C
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
Blood and lymphatic system disorders
High Blood Pressure
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
Infections and infestations
HIV
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Nausea
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Nose Fracture
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Rash
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
Surgical and medical procedures
Outpatient Laser Biopsy
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Tooth Extraction
|
0.85%
1/117 • 1 year
|
0.00%
0/120 • 1 year
|
|
General disorders
Cramps
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
Dizziness
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
Insomnia
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
Muscle Soreness
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
Stomach Pain
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
UTI
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
Surgical and medical procedures
Laser Surgery - Outpatient
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
|
General disorders
CORD/URI
|
0.00%
0/117 • 1 year
|
0.83%
1/120 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place