Trial Outcomes & Findings for Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence (NCT NCT01856712)

NCT ID: NCT01856712

Last Updated: 2019-03-05

Results Overview

Retention rate was measured in terms of percentage of participants attended an initial behavioral treatment visit within 2 weeks of hospital discharge.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 54 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-03-05

Participant Flow

9 participants who didn't receive medication were discharged from the hospital before they could get medication. Therefore, only 45 , out of 54 participants got the medication.

Participant milestones

Measure	Oral Naltrexone an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.	Injectable Naltrexone a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later. Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Overall Study STARTED	23	22
Overall Study Lost to 14 Day Follow up	6	2
Overall Study Lost to 45 Day Follow up	1	1
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention

Baseline characteristics by cohort

Measure	Oral Naltrexone n=23 Participants an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.	Injectable Naltrexone n=22 Participants a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later. Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	0 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	16 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	31 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention
Age, Categorical >=65 years	8 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	6 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	14 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention
Age, Continuous	50.9 years STANDARD_DEVIATION 14.5 • n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	48.3 years STANDARD_DEVIATION 12.9 • n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention	49.5 years STANDARD_DEVIATION 13.9 • n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention
Sex: Female, Male Female	1 Participants n=5 Participants • Oral naltrexone: 4 participants did not receive intervention Injectable naltrexone: 5 did not receive intervention	21 Participants n=7 Participants • Oral naltrexone: 4 participants did not receive intervention Injectable naltrexone: 5 did not receive intervention	22 Participants n=5 Participants • Oral naltrexone: 4 participants did not receive intervention Injectable naltrexone: 5 did not receive intervention
Sex: Female, Male Male	22 Participants n=5 Participants • Oral naltrexone: 4 participants did not receive intervention Injectable naltrexone: 5 did not receive intervention	1 Participants n=7 Participants • Oral naltrexone: 4 participants did not receive intervention Injectable naltrexone: 5 did not receive intervention	23 Participants n=5 Participants • Oral naltrexone: 4 participants did not receive intervention Injectable naltrexone: 5 did not receive intervention
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	2 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	5 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Race (NIH/OMB) White	20 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	20 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	40 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=7 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.	0 Participants n=5 Participants • Oral naltrexone: 4 did not receive intervention Injectable natrexone: 5 did not receive intervention. Not receiving intervention medication was related to discharge from the hospital prior to receiving.
Region of Enrollment United States	23 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Retention rate was measured in terms of percentage of participants attended an initial behavioral treatment visit within 2 weeks of hospital discharge.

Outcome measures

Measure	Oral Naltrexone n=23 Participants enrolled and received oral naltrexone	Injectable Naltrexone n=22 Participants enrolled and received injectable naltrexone
Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge.	23 Participants	22 Participants

SECONDARY outcome

Timeframe: 12 months

Attendance to recommended outpatient substance abuse treatment will be compared between injectable naltrexone group and oral naltrexone group. Keeping patients engaged in treatment is desirable and is known to improve addiction-related outcomes.

Outcome measures

Measure	Oral Naltrexone n=23 Participants enrolled and received oral naltrexone	Injectable Naltrexone n=22 Participants enrolled and received injectable naltrexone
Percentage of Patients Attended Recommended Outpatient Substance Abuse Treatment	19 Participants	18 Participants

SECONDARY outcome

Timeframe: 12 months

Medication adherence was measured as percentage of participants who took ≥ 80% of daily naltrexone doses determined via pill counts. Adherence of daily medication will predict treatment engagement following hospital discharge.

Outcome measures

Measure	Oral Naltrexone n=23 Participants enrolled and received oral naltrexone	Injectable Naltrexone n=22 Participants enrolled and received injectable naltrexone
Percentage of Participants Adhered to Medication	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 12 months

To compare study arms in terms of ongoing alcohol consumption. We hypothesize that (1) improved medication adherence in the oral naltrexone arm and (2) assignment to injectable naltrexone will be associated with reduced alcohol consumption (number of heavy drinking days in the past 14 days) following hospital discharge.

Outcome measures

Measure	Oral Naltrexone n=23 Participants enrolled and received oral naltrexone	Injectable Naltrexone n=22 Participants enrolled and received injectable naltrexone
Ongoing Alcohol Consumption	136.5 Total drinks Interval 1.0 to 364.0	114.5 Total drinks Interval 0.0 to 308.0

Adverse Events

Oral Naltrexone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Injectable Naltrexone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Naltrexone n=23 participants at risk an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.	Injectable Naltrexone n=22 participants at risk a single 380 mg intramuscular injection of naltrexone (duration of action = 30 days)prior to hospital discharge followed by a second injection one month later. Naltrexone: Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
Psychiatric disorders depression	4.3% 1/23 • Number of events 1 • from September 5, 2013 to April 20, 2015, for a total accrual time of 19 months	0.00% 0/22 • from September 5, 2013 to April 20, 2015, for a total accrual time of 19 months

Additional Information

Randall Brown

University of Wisconsin

Phone: 6082636558

Email: rtbrown@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place