Trial Outcomes & Findings for Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients (NCT NCT01559454)
NCT ID: NCT01559454
Last Updated: 2020-11-03
Results Overview
Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
6 months
Results posted on
2020-11-03
Participant Flow
Recruitment occurred between January 2012 and December 2013 at an ambulatory care medical clinic. Follow-up data collection lasted until May 2014
25 participants were assessed, but 6 were excluded for: unwilling to be randomized, DAST score below minimum, not opioid dependent, prior maintenance therapy, no prior surgery, and initial toxicology positive for cocaine (one patient per category)
Participant milestones
| Measure |
Methadone
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Methadone
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Baseline characteristics by cohort
| Measure |
Methadone
n=9 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=10 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
disabled
disabled
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.44 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
38.20 years
STANDARD_DEVIATION 9.16 • n=7 Participants
|
41.16 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
disabled
not disabled
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
never married
never married
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
never married
current of prior marriage
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
past lower back surgery
past lower back surgery
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
past lower back surgery
other spinal surgery
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
current treatment for back pain
current treatment
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
current treatment for back pain
past treatment
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
drug and alcohol treatment history
past addiction treatment
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
drug and alcohol treatment history
no past addiction treatment
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
criminal history
any prior arrest
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
criminal history
no prior arrests
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
education
some college
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
education
high school or less
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 19 participants were enrolled in the study, and 10 were available for the 6-month follow-up.
Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.
Outcome measures
| Measure |
Methadone
n=6 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=4 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Analgesia
|
36.3 units on a VAS scale
Standard Deviation 22.4
|
71.8 units on a VAS scale
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 19 participants were enrolled in the study, and 10 were available at the 6-month follow-up
Illicit opioid use will be measured by self-report and confirmed with urine toxicology.
Outcome measures
| Measure |
Methadone
n=6 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=4 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Illicit Drug Use
illicit drug use at 6 months
|
0 participants
|
0 participants
|
|
Illicit Drug Use
no illicit drug use at 6 months
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: at 6 monthsCravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings
Outcome measures
| Measure |
Methadone
n=6 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=4 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Cravings
|
11.7 units on a VAS scale
Standard Deviation 18.1
|
27.2 units on a VAS scale
Standard Deviation 31.7
|
SECONDARY outcome
Timeframe: at 6 monthsFunctioning will be assessed using the Visual Analogue Scale (VAS) with 0 being "no limits" and 100 being "bedridden."
Outcome measures
| Measure |
Methadone
n=6 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=4 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Functioning
|
31.7 units on a VAS scale
Standard Deviation 25.1
|
71.3 units on a VAS scale
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: at 6 monthsDepression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being "none" and 63 being "severe."
Outcome measures
| Measure |
Methadone
n=6 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=4 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Depression
|
17.0 units on a BDI scale
Standard Deviation 18.2
|
15.3 units on a BDI scale
Standard Deviation 14.2
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants that completed the study protocol
Outcome measures
| Measure |
Methadone
n=9 Participants
10-60 mg/day divided by 2-4 times a day
Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=10 Participants
4-16 mg/day divided by 2-4 times a day
Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months
|
|---|---|---|
|
Treatment Retention
completed
|
6 participants
|
4 participants
|
|
Treatment Retention
did not complete
|
3 participants
|
6 participants
|
Adverse Events
Methadone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Buprenorphine/Naloxone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methadone
n=9 participants at risk
Methadone 10-60 mg/day divided 2-4 times a day for 6 months
|
Buprenorphine/Naloxone
n=10 participants at risk
Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
|
|---|---|---|
|
Social circumstances
drug overdose
|
11.1%
1/9 • Number of events 1 • 6 months
Drug overdose
|
0.00%
0/10 • 6 months
Drug overdose
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place