Trial Outcomes & Findings for Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal (NCT NCT00980044)
NCT ID: NCT00980044
Last Updated: 2017-04-05
Results Overview
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
53 participants
Primary outcome timeframe
Days 1-7
Results posted on
2017-04-05
Participant Flow
Outpatient screening. Recruitment by advertisement and word or mouth.
Persons screening who did not meet inclusion/ exclusion criteria were not enrolled. Persons who did not complete the study were not included in analyses. The study was designed as an efficacy study that a priori stated it would enroll until 12 persons in each group completed the study and analyse only completers. No serious AEs in noncompleters.
Participant milestones
| Measure |
Tramadol 200 mg Daily
Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
|
Placebo
Placebo given for two weeks
|
Tramadol 600 mg Daily
Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
17
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
5
|
Reasons for withdrawal
| Measure |
Tramadol 200 mg Daily
Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
|
Placebo
Placebo given for two weeks
|
Tramadol 600 mg Daily
Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Baseline characteristics by cohort
| Measure |
Tramadol 200 mg
n=12 Participants
Medication: Extended release tramadol for 1 week and then placebo given for 1 week
|
Placebo
n=12 Participants
Medication: Placebo given for two weeks
|
Tramadol 600 mg
n=12 Participants
Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
36 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Days 1-7Population: The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Outcome measures
| Measure |
Tramadol 200 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
Placebo
n=12 Participants
Medication
|
Tramadol 600 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
|---|---|---|---|
|
Subjective Opioid Withdrawal Total Adjective Score
|
5.8 units on a scale
Standard Error 0.1
|
7.7 units on a scale
Standard Error 0.1
|
6.9 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Days 1-7Population: These are data from week 1 -- the 12 people who completed this week in each group. This is the analysis that was specified at the start of the study. The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Outcome measures
| Measure |
Tramadol 200 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
Placebo
n=12 Participants
Medication
|
Tramadol 600 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
|---|---|---|---|
|
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
|
1.8 Mean doses per day
Standard Error 0.2
|
2.5 Mean doses per day
Standard Error 0.2
|
3.1 Mean doses per day
Standard Error 0.3
|
PRIMARY outcome
Timeframe: days 8-13Population: The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean total withdrawal score across the days listed.
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Outcome measures
| Measure |
Tramadol 200 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
Placebo
n=12 Participants
Medication
|
Tramadol 600 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
|---|---|---|---|
|
Subjective Opioid Withdrawal Adjective Total Score Week 2
|
2.7 units on a scale
Standard Error 0.2
|
2.9 units on a scale
Standard Error 0.2
|
2.7 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Days 8-13 (all groups now on placebo)Population: The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean number of doses/day across the days listed.
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Outcome measures
| Measure |
Tramadol 200 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
Placebo
n=12 Participants
Medication
|
Tramadol 600 mg Daily
n=12 Participants
Medication: Extended release tramadol
|
|---|---|---|---|
|
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
|
1.8 mean # of doses per day
Standard Error 0.2
|
1.6 mean # of doses per day
Standard Error 0.1
|
3.2 mean # of doses per day
Standard Error 0.2
|
Adverse Events
Tramadol 200 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tramadol 600 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tramadol 200 mg
n=17 participants at risk
Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week
|
Placebo
n=19 participants at risk
Medication: Placebo for 2 weeks
|
Tramadol 600 mg
n=17 participants at risk
Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week
|
|---|---|---|---|
|
Renal and urinary disorders
unsteady urine flow without dysuria
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Infections and infestations
sore throat/strep B
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Gastrointestinal disorders
abdominal pain
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.3%
1/19 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Musculoskeletal and connective tissue disorders
fleeting chest pain
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Musculoskeletal and connective tissue disorders
left shoulder pain
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.3%
1/19 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Musculoskeletal and connective tissue disorders
tooth pain
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Infections and infestations
sore throat with cough
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
|
Infections and infestations
athletes foot
|
5.9%
1/17 • Number of events 1
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/19
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
0.00%
0/17
There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
|
Additional Information
Michelle Lofwall, MD, Associate Professor
University of Kentucky College of Medicine
Phone: 8593239321
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place