Trial Outcomes & Findings for Medications Development for Drug Abuse Disorders (NCT NCT01188421)
NCT ID: NCT01188421
Last Updated: 2017-07-06
Results Overview
Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
106 participants
Primary outcome timeframe
14 days total
Results posted on
2017-07-06
Participant Flow
Participant milestones
| Measure |
Buprenorphine
Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day
|
Tramadol ER
Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day
|
Clonidine
Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
36
|
36
|
|
Overall Study
COMPLETED
|
28
|
26
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medications Development for Drug Abuse Disorders
Baseline characteristics by cohort
| Measure |
Buprenorphine
n=31 Participants
Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day
|
Tramadol ER
n=36 Participants
Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day
|
Clonidine
n=36 Participants
Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38.7 percentage of participants
n=5 Participants
|
47.2 percentage of participants
n=7 Participants
|
41.6 percentage of participants
n=5 Participants
|
42.5 percentage of participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days totalPopulation: Repeated measures ANOVA
Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal.
Outcome measures
| Measure |
Buprenorphine
n=31 Participants
Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day
|
Tramadol ER
n=36 Participants
Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day
|
Clonidine
n=36 Participants
Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)
|
|---|---|---|---|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 1
|
7.79 units on a scale
Standard Error 1.68
|
8.41 units on a scale
Standard Error 0.70
|
8.28 units on a scale
Standard Error 0.71
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 2
|
6.16 units on a scale
Standard Error 2.03
|
6.10 units on a scale
Standard Error 0.72
|
8.00 units on a scale
Standard Error 0.46
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 3
|
4.76 units on a scale
Standard Error 1.77
|
3.77 units on a scale
Standard Error 0.35
|
5.85 units on a scale
Standard Error 0.66
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 4
|
4.21 units on a scale
Standard Error 1.77
|
4.25 units on a scale
Standard Error 0.52
|
4.70 units on a scale
Standard Error 0.57
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 5
|
4.31 units on a scale
Standard Error 2.11
|
3.25 units on a scale
Standard Error 0.37
|
3.32 units on a scale
Standard Error 0.41
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 6
|
4.06 units on a scale
Standard Error 1.63
|
3.39 units on a scale
Standard Error 0.45
|
3.57 units on a scale
Standard Error 0.57
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Taper Day 7
|
3.51 units on a scale
Standard Error 1.28
|
3.69 units on a scale
Standard Error 0.53
|
3.86 units on a scale
Standard Error 0.64
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 1
|
4.82 units on a scale
Standard Error 1.62
|
3.36 units on a scale
Standard Error 0.44
|
3.27 units on a scale
Standard Error 0.37
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 2
|
5.62 units on a scale
Standard Error 1.90
|
4.48 units on a scale
Standard Error 0.60
|
4.09 units on a scale
Standard Error 0.60
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 3
|
6.23 units on a scale
Standard Error 1.75
|
3.28 units on a scale
Standard Error 0.28
|
3.68 units on a scale
Standard Error 0.38
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 4
|
5.49 units on a scale
Standard Error 1.66
|
3.13 units on a scale
Standard Error 0.24
|
3.82 units on a scale
Standard Error 0.46
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 5
|
5.87 units on a scale
Standard Error 1.69
|
2.75 units on a scale
Standard Error 0.24
|
3.27 units on a scale
Standard Error 0.35
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 6
|
4.91 units on a scale
Standard Error 1.62
|
2.57 units on a scale
Standard Error 0.26
|
2.91 units on a scale
Standard Error 0.31
|
|
Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
Post Taper Day 7
|
4.91 units on a scale
Standard Error 1.69
|
2.30 units on a scale
Standard Error 0.23
|
2.41 units on a scale
Standard Error 0.31
|
Adverse Events
Buprenorphine
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Tramadol ER
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Clonidine
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buprenorphine
n=31 participants at risk
Sublingual buprenorphine/naloxone tablets (or placebo)
Buprenorphine/naloxone: up to 8/2 mg SL per day
|
Tramadol ER
n=36 participants at risk
Oral tramadol tablets (or placebo)
Tramadol ER: up to 600 mg per day
|
Clonidine
n=36 participants at risk
Oral clonidine tablets (or placebo)
Clonidine: up to 0.8 mg per day (oral)
|
|---|---|---|---|
|
General disorders
Chills
|
29.0%
9/31 • Number of events 11 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
36.1%
13/36 • Number of events 20 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
47.2%
17/36 • Number of events 21 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Drowsiness
|
3.2%
1/31 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Headache
|
54.8%
17/31 • Number of events 22 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
38.9%
14/36 • Number of events 22 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
27.8%
10/36 • Number of events 19 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Lethargy
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
8.3%
3/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Malaise
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Abdominal Pain
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
0.00%
0/36 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Cardiac disorders
Hypotension
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
0.00%
0/36 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
16.7%
6/36 • Number of events 7 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
0.00%
0/36 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Cardiac disorders
Tachycardia
|
19.4%
6/31 • Number of events 10 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
22.2%
8/36 • Number of events 11 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
25.0%
9/36 • Number of events 9 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Abdominal Cramp
|
29.0%
9/31 • Number of events 9 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
38.9%
14/36 • Number of events 16 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Diarrhea
|
41.9%
13/31 • Number of events 18 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
25.0%
9/36 • Number of events 15 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
55.6%
20/36 • Number of events 25 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
3/31 • Number of events 3 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
25.0%
9/36 • Number of events 11 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Flatulance
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
8.3%
3/36 • Number of events 3 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Indigestion
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Nausea
|
16.1%
5/31 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
8.3%
3/36 • Number of events 3 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
25.0%
9/36 • Number of events 10 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Gastrointestinal disorders
Vomitting
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
8.3%
3/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.1%
5/31 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
13.9%
5/36 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.9%
4/31 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
16.7%
6/36 • Number of events 9 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Musculoskeletal and connective tissue disorders
Cramp Lower Extremity
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
0.00%
0/36 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Musculoskeletal and connective tissue disorders
Muscle Ache
|
35.5%
11/31 • Number of events 14 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
30.6%
11/36 • Number of events 16 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
27.8%
10/36 • Number of events 10 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Musculoskeletal and connective tissue disorders
Pain Lower Extremity
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Agitation
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Anxiety
|
25.8%
8/31 • Number of events 9 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
27.8%
10/36 • Number of events 15 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
27.8%
10/36 • Number of events 11 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Fatigue
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
16.7%
6/36 • Number of events 7 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
13.9%
5/36 • Number of events 10 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Insomnia
|
38.7%
12/31 • Number of events 18 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
41.7%
15/36 • Number of events 18 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
38.9%
14/36 • Number of events 17 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Irritability
|
9.7%
3/31 • Number of events 3 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
25.0%
9/36 • Number of events 13 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
33.3%
12/36 • Number of events 12 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Restlessness
|
38.7%
12/31 • Number of events 15 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
41.7%
15/36 • Number of events 20 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
30.6%
11/36 • Number of events 11 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Shaky
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
0.00%
0/36 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Nervous system disorders
Tremor
|
32.3%
10/31 • Number of events 13 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
25.0%
9/36 • Number of events 14 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
22.2%
8/36 • Number of events 8 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Cough
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
0.00%
0/36 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Nasal Congestion
|
16.1%
5/31 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
13.9%
5/36 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
16.7%
6/36 • Number of events 7 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Rhinitis
|
0.00%
0/31 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 5 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
5.6%
2/36 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Rhinorrhea
|
41.9%
13/31 • Number of events 15 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
27.8%
10/36 • Number of events 14 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
27.8%
10/36 • Number of events 16 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Yawning
|
25.8%
8/31 • Number of events 11 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
16.7%
6/36 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Piloerection
|
16.1%
5/31 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
11.1%
4/36 • Number of events 4 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
2.8%
1/36 • Number of events 1 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
General disorders
Sweat Increased
|
19.4%
6/31 • Number of events 8 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
13.9%
5/36 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
16.7%
6/36 • Number of events 6 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Eye disorders
Hot Flashes
|
19.4%
6/31 • Number of events 7 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
19.4%
7/36 • Number of events 7 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
22.2%
8/36 • Number of events 9 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
|
Eye disorders
Lacrimation Increased
|
6.5%
2/31 • Number of events 2 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
22.2%
8/36 • Number of events 10 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
19.4%
7/36 • Number of events 7 • Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
|
Additional Information
Eric C. Strain, MD
Johns Hopkins University, School of Medicine
Phone: 410-550-1191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place