Trial Outcomes & Findings for Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults (NCT NCT01052662)
NCT ID: NCT01052662
Last Updated: 2015-04-01
Results Overview
The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
87 participants
Primary outcome timeframe
Weekly from week 1 to 13
Results posted on
2015-04-01
Participant Flow
Recruitment was done by newspaper advertising, referrals from the University of Massachusetts Addiction and Comorbidity Treatment Service (ACTS) and from community-based substance abuse clinics.
229 individuals of the 354 persons who were interested in the study were assessed not eligible to participate. Of the 125 subjects that were screen over one week, only 87 subjects meet criteria for study participation. Reason for exclusion included: declined (N=22), psychiatric (N=6), other SUD (N=6), abnormal labs (N=3) and medical reason (N=1)
Participant milestones
| Measure |
Memantine 30mg/Day + Buprenorphine
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
32
|
|
Overall Study
Stabilization Phase
|
21
|
21
|
26
|
|
Overall Study
Discontinuation Phase
|
6
|
5
|
10
|
|
Overall Study
COMPLETED
|
6
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
22
|
Reasons for withdrawal
| Measure |
Memantine 30mg/Day + Buprenorphine
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
13
|
18
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
|
Overall Study
Pharmacy issue
|
1
|
3
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Legal Problem
|
2
|
0
|
0
|
|
Overall Study
Administrative
|
0
|
3
|
0
|
Baseline Characteristics
Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults
Baseline characteristics by cohort
| Measure |
Memantine 30mg/Day + Buprenorphine
n=27 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
n=24 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
n=29 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
22.4 years
STANDARD_DEVIATION 2 • n=7 Participants
|
22.4 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
22.6 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucacian
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
27 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
29 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Opioid use
Heroin use
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Opioid use
Opioid analgesic use
|
22 participants
n=5 Participants
|
17 participants
n=7 Participants
|
24 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
Years of opioid use
Heroin use
|
1.1 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
1 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
1.1 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
1.08 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
Years of opioid use
Opioid Analgesic use
|
2.8 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.9 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.7 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
3.2 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Severity of Dependence Scale
|
11.2 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Clinical Opiate Withdrawal Scale (COWS)
|
10.4 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 2.8 • n=7 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 3.1 • n=4 Participants
|
|
Heroin Craving Questionnaire - Short Form 14 (HCQ-SF-14)
|
4.2 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.5 units on a scale
STANDARD_DEVIATION 1 • n=7 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1 • n=4 Participants
|
|
Center for Epidemiologic Studies Depression scale (CES-D)
|
23.6 units on a scale
STANDARD_DEVIATION 9 • n=5 Participants
|
20 units on a scale
STANDARD_DEVIATION 9.7 • n=7 Participants
|
22.8 units on a scale
STANDARD_DEVIATION 11 • n=5 Participants
|
22.4 units on a scale
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Barratt Impulsivity Questionnaire
|
72.4 units on a scale
STANDARD_DEVIATION 10.9 • n=5 Participants
|
70.4 units on a scale
STANDARD_DEVIATION 10.3 • n=7 Participants
|
69.7 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
70.8 units on a scale
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Inhibitory Control (mean % error)
|
0.24 mean percentage of error (prosaccade)
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.2 mean percentage of error (prosaccade)
STANDARD_DEVIATION 0.11 • n=7 Participants
|
0.2 mean percentage of error (prosaccade)
STANDARD_DEVIATION 0.17 • n=5 Participants
|
0.21 mean percentage of error (prosaccade)
STANDARD_DEVIATION 0.17 • n=4 Participants
|
PRIMARY outcome
Timeframe: Weekly from week 1 to 13Population: 80 subjects intent-to-treat.
The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.
Outcome measures
| Measure |
Memantine 30mg/Day + Buprenorphine
n=27 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
n=24 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
n=29 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
|---|---|---|---|
|
Change of Opioid Use From Week 1 to 13
|
0.00 Mean Proportion of Opioid Use in Week 13
Standard Error 0.0
|
0.27 Mean Proportion of Opioid Use in Week 13
Standard Error 0.10
|
0.39 Mean Proportion of Opioid Use in Week 13
Standard Error 0.14
|
PRIMARY outcome
Timeframe: Weeks after buprenorphine discontinuation week 9Population: Participants that achieved complete abstinence by self-report that was confirmed with negative urine toxicology at week 8.
Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.
Outcome measures
| Measure |
Memantine 30mg/Day + Buprenorphine
n=12 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
n=3 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
n=14 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
|---|---|---|---|
|
Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8
|
5 participants
|
1 participants
|
8 participants
|
SECONDARY outcome
Timeframe: WeeklyPopulation: Intent-treat-sample (ITT) that was inducted onto buprenorphine / naloxone and received one dose of study medication on week 2.
Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.
Outcome measures
| Measure |
Memantine 30mg/Day + Buprenorphine
n=27 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
n=24 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
n=29 Participants
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
|---|---|---|---|
|
Treatment Retention
|
9.3 weeks in treatment
Interval 8.3 to 10.2
|
9 weeks in treatment
Interval 7.8 to 10.3
|
9.7 weeks in treatment
Interval 8.6 to 10.6
|
Adverse Events
Memantine 30mg/Day + Buprenorphine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Memantine 15mg/Day + Buprenorphine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Memantine 0mg/Day + Buprenorphine
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Memantine 30mg/Day + Buprenorphine
n=27 participants at risk
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 30mg/day Memantine orally everyday for 12 weeks
|
Memantine 15mg/Day + Buprenorphine
n=24 participants at risk
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Memantine: 15 mg/day Memantine orally everyday for 12 weeks
|
Memantine 0mg/Day + Buprenorphine
n=29 participants at risk
Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.
Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.
Placebo: Placebo orally everyday for 12 weeks
|
|---|---|---|---|
|
Nervous system disorders
Pain
|
11.1%
3/27 • Number of events 5 • Adverse events were collected from week 1 to week 13.
|
12.5%
3/24 • Number of events 5 • Adverse events were collected from week 1 to week 13.
|
31.0%
9/29 • Number of events 15 • Adverse events were collected from week 1 to week 13.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Intection
|
11.1%
3/27 • Number of events 5 • Adverse events were collected from week 1 to week 13.
|
4.2%
1/24 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
6.9%
2/29 • Number of events 4 • Adverse events were collected from week 1 to week 13.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
13.8%
4/29 • Number of events 5 • Adverse events were collected from week 1 to week 13.
|
|
Psychiatric disorders
Vivid Dreams
|
11.1%
3/27 • Number of events 3 • Adverse events were collected from week 1 to week 13.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from week 1 to week 13.
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Number of events 4 • Adverse events were collected from week 1 to week 13.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from week 1 to week 13.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • Adverse events were collected from week 1 to week 13.
|
12.5%
3/24 • Number of events 3 • Adverse events were collected from week 1 to week 13.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
|
Nervous system disorders
Drowsiness
|
7.4%
2/27 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
8.3%
2/24 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from week 1 to week 13.
|
Additional Information
Gerardo Gonzalez, MD
University of Massachusetts Medical School
Phone: 508 856 6480
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place