Trial Outcomes & Findings for Clinical Trial of Integrated Treatment for Pain and Opioid Dependence (NCT NCT00634803)
NCT ID: NCT00634803
Last Updated: 2021-08-02
Results Overview
Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
90 participants
Primary outcome timeframe
3 months
Results posted on
2021-08-02
Participant Flow
Participant milestones
| Measure |
CBT for POD
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone
|
Educational Counseling for POD
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians
|
Physician Management
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
Month 1
|
29
|
29
|
29
|
|
Overall Study
Month 2
|
26
|
26
|
28
|
|
Overall Study
Month 3
|
25
|
23
|
26
|
|
Overall Study
COMPLETED
|
24
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
7
|
Reasons for withdrawal
| Measure |
CBT for POD
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone
|
Educational Counseling for POD
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians
|
Physician Management
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
7
|
Baseline Characteristics
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Baseline characteristics by cohort
| Measure |
CBT for POD
n=30 Participants
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone
|
Educational Counseling for POD
n=30 Participants
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians
|
Physician Management
n=30 Participants
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling
|
Total
n=90 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
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
90 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
|
35.3 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 10.00 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
90 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The analysis population is the intention to treat population and all observations across time periods were used in the analysis.
Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe.
Outcome measures
| Measure |
CBT for POD
n=30 Participants
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone
|
Educational Counseling for POD
n=30 Participants
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians
|
Physician Management
n=30 Participants
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling
|
|---|---|---|---|
|
Pain Intensity
Intake/Induction
|
5.43 units on a scale
Standard Deviation 1.34
|
5.92 units on a scale
Standard Deviation 1.57
|
5.28 units on a scale
Standard Deviation 1.34
|
|
Pain Intensity
Month 1
|
4.75 units on a scale
Standard Deviation 1.62
|
5.02 units on a scale
Standard Deviation 1.45
|
4.53 units on a scale
Standard Deviation 1.46
|
|
Pain Intensity
Month 2
|
4.79 units on a scale
Standard Deviation 1.50
|
4.98 units on a scale
Standard Deviation 1.76
|
4.72 units on a scale
Standard Deviation 1.81
|
|
Pain Intensity
Month 3
|
4.41 units on a scale
Standard Deviation 1.67
|
4.62 units on a scale
Standard Deviation 1.91
|
4.84 units on a scale
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: The analysis population is the intention to treat population and all observations across time periods were used in the analysis. Participants may have contributed to this outcome but were lost to follow up during the time period and were not measured on pain related outcomes.
Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled "Reduced illicit opioid use" and the timeframe was listed as 16 weeks.
Outcome measures
| Measure |
CBT for POD
n=30 Participants
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone
|
Educational Counseling for POD
n=30 Participants
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians
|
Physician Management
n=30 Participants
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling
|
|---|---|---|---|
|
Number of Opioid-negative Urine Toxicology Tests
Intake/Induction
|
0.67 opioid negative urine tests
Standard Deviation 0.55
|
0.67 opioid negative urine tests
Standard Deviation 0.48
|
0.55 opioid negative urine tests
Standard Deviation 0.69
|
|
Number of Opioid-negative Urine Toxicology Tests
Month 1
|
2.67 opioid negative urine tests
Standard Deviation 1.42
|
2.80 opioid negative urine tests
Standard Deviation 1.27
|
2.48 opioid negative urine tests
Standard Deviation 1.70
|
|
Number of Opioid-negative Urine Toxicology Tests
Month 2
|
2.96 opioid negative urine tests
Standard Deviation 1.48
|
3.30 opioid negative urine tests
Standard Deviation 1.14
|
2.56 opioid negative urine tests
Standard Deviation 1.72
|
|
Number of Opioid-negative Urine Toxicology Tests
Month 3
|
2.80 opioid negative urine tests
Standard Deviation 1.38
|
3.25 opioid negative urine tests
Standard Deviation 1.22
|
2.04 opioid negative urine tests
Standard Deviation 1.71
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: The analysis population is the intention to treat population and all observations across time periods were used in the analysis.
Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference.
Outcome measures
| Measure |
CBT for POD
n=30 Participants
Integrated cognitive behavioral therapy for chronic pain and opioid dependence
CBT: Cognitive behavioral therapy
Buprenorphine: buprenorphine/naloxone
|
Educational Counseling for POD
n=30 Participants
Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM)
Buprenorphine: buprenorphine/naloxone
Educational Counseling: Didactic, lecture-discussion format to supplement information and advice provided by physicians
|
Physician Management
n=30 Participants
PM is a relatively brief intervention that approximates the medically focused advice and brief counseling about medical issues that is typically provided by physicians to patients with chronic pain or other chronic medical conditions, such as diabetes or asthma.
Buprenorphine: buprenorphine/naloxone
Physician Management: Brief physician counseling
|
|---|---|---|---|
|
Pain Interference
Intake/Induction
|
5.75 units on a scale
Standard Deviation 2.12
|
5.48 units on a scale
Standard Deviation 2.23
|
5.01 units on a scale
Standard Deviation 2.19
|
|
Pain Interference
Month 1
|
4.15 units on a scale
Standard Deviation 2.09
|
3.74 units on a scale
Standard Deviation 1.82
|
3.32 units on a scale
Standard Deviation 2.12
|
|
Pain Interference
Month 2
|
4.08 units on a scale
Standard Deviation 2.06
|
3.61 units on a scale
Standard Deviation 1.97
|
3.45 units on a scale
Standard Deviation 2.45
|
|
Pain Interference
Month 3
|
3.22 units on a scale
Standard Deviation 1.94
|
3.23 units on a scale
Standard Deviation 2.27
|
3.87 units on a scale
Standard Deviation 2.56
|
Adverse Events
CBT for POD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educational Counseling for POD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physician Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place