Trial Outcomes & Findings for Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone (NCT NCT00577408)
NCT ID: NCT00577408
Last Updated: 2017-08-25
Results Overview
compliance with being retained in treatment protocol
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
over the course of 24 weeks or length of study participation
Results posted on
2017-08-25
Participant Flow
Participant milestones
| Measure |
Depot Naltrexone
Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
|
Oral Naltrexone
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
32
|
|
Overall Study
COMPLETED
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
12
|
23
|
Reasons for withdrawal
| Measure |
Depot Naltrexone
Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
|
Oral Naltrexone
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
|
|---|---|---|
|
Overall Study
Stopped attending study visits
|
9
|
11
|
|
Overall Study
Continued opioid use
|
3
|
2
|
|
Overall Study
Non-compliance with study meds
|
0
|
3
|
|
Overall Study
Refused Oral Naltrexone
|
0
|
1
|
|
Overall Study
Moved out of state
|
0
|
1
|
|
Overall Study
Scheduling Issues
|
0
|
3
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Psychiatric hospitalization
|
0
|
1
|
Baseline Characteristics
Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
Baseline characteristics by cohort
| Measure |
Depot Naltrexone
n=28 Participants
Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
|
Oral Naltrexone
n=32 Participants
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
32 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over the course of 24 weeks or length of study participationcompliance with being retained in treatment protocol
Outcome measures
| Measure |
Depot Naltrexone
n=28 Participants
Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
|
Oral Naltrexone
n=32 Participants
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
|
|---|---|---|
|
Treatment Retention
24 Weeks
|
16 Participants
|
9 Participants
|
|
Treatment Retention
4 Weeks
|
24 Participants
|
20 Participants
|
|
Treatment Retention
12 Weeks
|
17 Participants
|
14 Participants
|
Adverse Events
Depot Naltrexone
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
Oral Naltrexone
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Depot Naltrexone
n=28 participants at risk
Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
|
Oral Naltrexone
n=32 participants at risk
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
|
|---|---|---|
|
Vascular disorders
hypertension
|
3.6%
1/28 • Number of events 1 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
|
Vascular disorders
chest pain
|
0.00%
0/28 • 24 weeks
|
3.1%
1/32 • Number of events 1 • 24 weeks
|
|
Reproductive system and breast disorders
Spontaneous abortion
|
3.6%
1/28 • Number of events 1 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Allergic reaction
|
3.6%
1/28 • Number of events 1 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
|
Psychiatric disorders
increased anxiety
|
3.6%
1/28 • Number of events 1 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
|
Psychiatric disorders
Cannabis induced psychosis
|
0.00%
0/28 • 24 weeks
|
3.1%
1/32 • Number of events 1 • 24 weeks
|
|
Vascular disorders
Cardiac death
|
0.00%
0/28 • 24 weeks
|
3.1%
1/32 • Number of events 1 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
car accident
|
7.1%
2/28 • Number of events 2 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
Other adverse events
| Measure |
Depot Naltrexone
n=28 participants at risk
Depot Naltrexone. Vivitrol (380 mg)given monthly depot naltrexone: On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
|
Oral Naltrexone
n=32 participants at risk
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Oral Naltrexone: For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
25.0%
7/28 • Number of events 7 • 24 weeks
|
43.8%
14/32 • Number of events 14 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/28 • 24 weeks
|
18.8%
6/32 • Number of events 6 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
17.9%
5/28 • Number of events 5 • 24 weeks
|
15.6%
5/32 • Number of events 5 • 24 weeks
|
|
Psychiatric disorders
depression
|
14.3%
4/28 • Number of events 4 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
Additional Information
Edward V. Nunes, MD
New York State Psychiatric Institute
Phone: 646-774-6122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place