Trial Outcomes & Findings for Improving Treatment Outcomes for Prescription Opioid Dependence (NCT NCT02543944)
NCT ID: NCT02543944
Last Updated: 2022-07-28
Results Overview
Thrice weekly urine samples obtained during weeks 1-3; data include assessments from week 1 day 1 through week 4 day 1 (up to 10 total samples per participant)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition)
Results posted on
2022-07-28
Participant Flow
Participant milestones
| Measure |
Gabapentin
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
|---|---|---|
|
Phase 1: GBN/BUP Induction and BUP Detox
STARTED
|
60
|
57
|
|
Phase 1: GBN/BUP Induction and BUP Detox
COMPLETED
|
41
|
34
|
|
Phase 1: GBN/BUP Induction and BUP Detox
NOT COMPLETED
|
19
|
23
|
|
Phase 2: Transition From BUP to XR-NTX
STARTED
|
33
|
29
|
|
Phase 2: Transition From BUP to XR-NTX
COMPLETED
|
12
|
12
|
|
Phase 2: Transition From BUP to XR-NTX
NOT COMPLETED
|
21
|
17
|
|
Phase 3: XR-NTX Maintenance
STARTED
|
12
|
12
|
|
Phase 3: XR-NTX Maintenance
COMPLETED
|
7
|
3
|
|
Phase 3: XR-NTX Maintenance
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Treatment Outcomes for Prescription Opioid Dependence
Baseline characteristics by cohort
| Measure |
Gabapentin
n=60 Participants
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
n=57 Participants
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
110 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
|
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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
60 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Education Level
Less than High School
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education Level
High School/Some College/Vocational School
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Education Level
College Degree or higher
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education Level
Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition)Population: those starting on study medication
Thrice weekly urine samples obtained during weeks 1-3; data include assessments from week 1 day 1 through week 4 day 1 (up to 10 total samples per participant)
Outcome measures
| Measure |
Gabapentin
n=455 urine samples
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
n=421 urine samples
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
|---|---|---|
|
Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time
|
35.0 percentage of urine positive samples
Standard Deviation 36.7
|
41.6 percentage of urine positive samples
Standard Deviation 38.5
|
SECONDARY outcome
Timeframe: 3 days (wk 4 day 1 - week 4 day 3)% of Participants who completed the detox and started the NTX transition
Outcome measures
| Measure |
Gabapentin
n=41 Participants
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
n=34 Participants
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
|---|---|---|
|
NTX Transition Initiation
|
33 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 5 days (week 4 day 1 to week 4 day 5)% of participants starting the NTX transition who received Vivitrol injection
Outcome measures
| Measure |
Gabapentin
n=33 Participants
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
n=29 Participants
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
|---|---|---|
|
Vivitrol Injection Receivers
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 weeks (week 1-3)% of enrolled participants who completed the Detox Phase
Outcome measures
| Measure |
Gabapentin
n=60 Participants
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
n=57 Participants
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
|---|---|---|
|
Detox Phase Completers
|
41 Participants
|
34 Participants
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=60 participants at risk
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Gabapentin: N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo
n=57 participants at risk
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5.
Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3.
During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4).
Buprenorphine: All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
Clonidine: All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
Naltrexone (oral): All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
Naltrexone (depot): All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Placebo: Microcrystalline cellulose
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • 12 weeks
|
8.8%
5/57 • Number of events 5 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
4/60 • Number of events 4 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
Gastrointestinal disorders
Heartburn
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Gastrointestinal disorders
Stomach cramps
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain/soreness
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Gastrointestinal disorders
Loose, pale stools
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
4/60 • Number of events 4 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
Urination changes
|
10.0%
6/60 • Number of events 7 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
Bright colored urine
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Sedation/drowsiness
|
13.3%
8/60 • Number of events 8 • 12 weeks
|
7.0%
4/57 • Number of events 4 • 12 weeks
|
|
General disorders
Listlessness/loss of energy
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Fatigue
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
General disorders
Weakness
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Insomnia
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Sleep disturbance/sleep walking
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Restlessness
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Nervous system disorders
Muscle twitches/tremors
|
8.3%
5/60 • Number of events 6 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
Nervous system disorders
Tingling extremities
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle/skeletal pain/discomfort
|
6.7%
4/60 • Number of events 5 • 12 weeks
|
1.8%
1/57 • Number of events 2 • 12 weeks
|
|
General disorders
Tooth pain
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Changes in equilibrium
|
0.00%
0/60 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Fall
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Headache
|
11.7%
7/60 • Number of events 7 • 12 weeks
|
14.0%
8/57 • Number of events 8 • 12 weeks
|
|
General disorders
Dry mouth
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
Eye disorders
Dry eyes
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Eye disorders
Burning sensation in eyes
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Eye disorders
Blood shot eye
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Eye disorders
Changes in vision
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Changes in taste
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/60 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash on knees
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Diagnosis of shingles
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Infection
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Injury, poisoning and procedural complications
Injection site reaction
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Bruising/laceration
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
3.5%
2/57 • Number of events 3 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
General disorders
Hiccups
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Cardiac disorders
Elevated heart rate
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Edema/swelling
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Hot/cold sweats
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Continuously hot all day
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Fever
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Flu virus
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Sexual side effect
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Auditory and visual hallucinations
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Confusion/Disorientation
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Irritability
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Agitation
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Anger
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Psychiatric disorders
Symptoms of anxiety
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Psychiatric disorders
Dysphoria
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
Psychiatric disorders
Symptoms of depression and/or anhedonia
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal symptoms
|
21.7%
13/60 • Number of events 14 • 12 weeks
|
33.3%
19/57 • Number of events 25 • 12 weeks
|
|
General disorders
Withdrawal symptoms: not specified
|
5.0%
3/60 • Number of events 3 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Related to dehydration
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Leg pain
|
0.00%
0/60 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Withdrawal sx: Muscle cramps
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Bone/muscle pain
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Withdrawal sx: Stomach cramps
|
3.3%
2/60 • Number of events 3 • 12 weeks
|
15.8%
9/57 • Number of events 9 • 12 weeks
|
|
Gastrointestinal disorders
Withdrawal sx: Nausea
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
10.5%
6/57 • Number of events 6 • 12 weeks
|
|
Gastrointestinal disorders
Withdrawal sx: Vomiting
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
7.0%
4/57 • Number of events 4 • 12 weeks
|
|
Gastrointestinal disorders
Withdrawal sx: Diarrhea
|
3.3%
2/60 • Number of events 3 • 12 weeks
|
15.8%
9/57 • Number of events 9 • 12 weeks
|
|
General disorders
Withdrawal sx: Abdominal pain
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Loss of appetite
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Withdrawal sx: Constipation
|
0.00%
0/60 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Withdrawal sx: Runny nose/sneezing and/or watery eyes
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
General disorders
Withdrawal sx: Chills
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Hot/cold sweats
|
0.00%
0/60 • 12 weeks
|
8.8%
5/57 • Number of events 6 • 12 weeks
|
|
General disorders
Withdrawal sx: Excessive sweating
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
General disorders
Withdrawal sx: Fatigue
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Sedation
|
0.00%
0/60 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Withdrawal sx: Nodding off
|
0.00%
0/60 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Withdrawal sx: Insomnia
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
General disorders
Withdrawal sx: Restlessness
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
5.3%
3/57 • Number of events 3 • 12 weeks
|
|
General disorders
Withdrawal sx: Yawning
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Withdrawal sx: Stretching
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Withdrawal sx: Muscle twiches/jerks
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Shakes/tremors
|
3.3%
2/60 • Number of events 2 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Tingling extremities
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
0.00%
0/57 • 12 weeks
|
|
General disorders
Withdrawal sx: Headache
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Lightheaded
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Short of breath
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Dizziness
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Clammy feet/hands
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Gooseflesh
|
0.00%
0/60 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Depression
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
|
General disorders
Withdrawal sx: Anxiety
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
3.5%
2/57 • Number of events 2 • 12 weeks
|
|
General disorders
Withdrawal sx: Irritability
|
1.7%
1/60 • Number of events 1 • 12 weeks
|
1.8%
1/57 • Number of events 1 • 12 weeks
|
Additional Information
Dr. Alison H. Oliveto, PhD
University of Arkansas for Medical Sciences
Phone: 501-526-8441
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place