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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA024695-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.
This study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (CBT) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (POD).
Specific Aims:
The secondary outcomes: Development of a Treatment Manual and Development and Modification of Initial Therapy Training and Process Rating Measures were process measures and not been to be included as measures associated with RCT. These outcomes were removed when the RCT results were entered. In addition, outcomes were renamed for clarification.
At results entry, the timeframe (16 weeks) was also corrected to account for the actual timeframe used for analysis in the study. The 16-week study period listed in the protocol included a 2-week buprenorphine induction period (before randomization) and up to a 2-week post-conclusion of the clinical trial continuation on buprenorphine and referral to continuing treatment. In prior studies with buprenorphine, the study team had observed an artificially high attrition during the last 2 weeks of the planned study protocol, when participants were attempting to transition to available clinical treatments outside of the study. Consequently, as per the original study protocol for this study, the plan was to analyze intake and induction data (as baseline data) and then the data from the first 12-weeks post-randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for POD | Experimental | Integrated cognitive behavioral therapy for chronic pain and opioid dependence |
|
| Educational Counseling for POD | Active Comparator | Educational Counseling is a didactic, lecture-discussion format to supplement the information and advice provided by physicians in physician management (PM) |
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| Physician Management | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | Cognitive behavioral therapy |
| |
| Buprenorphine |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | 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. | 3 months |
| Number of Opioid-negative Urine Toxicology Tests | 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. | 3 Months |
| Pain Interference | 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. | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Schottenfeld, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methadone Research Unit | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27574837 | Derived | Barry DT, Cutter CJ, Beitel M, Kerns RD, Liong C, Schottenfeld RS. Psychiatric Disorders Among Patients Seeking Treatment for Co-Occurring Chronic Pain and Opioid Use Disorder. J Clin Psychiatry. 2016 Oct;77(10):1413-1419. doi: 10.4088/JCP.15m09963. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT for POD | Integrated cognitive behavioral therapy for chronic pain and opioid dependence CBT: Cognitive behavioral therapy Buprenorphine: buprenorphine/naloxone |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT for POD | Integrated cognitive behavioral therapy for chronic pain and opioid dependence CBT: Cognitive behavioral therapy Buprenorphine: buprenorphine/naloxone |
| BG001 | Educational Counseling for POD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity | 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. | The analysis population is the intention to treat population and all observations across time periods were used in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
Up to the end of study (month 3)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT for POD | Integrated cognitive behavioral therapy for chronic pain and opioid dependence CBT: Cognitive behavioral therapy Buprenorphine: buprenorphine/naloxone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard S. Schottenfeld, M.D. | Yale University | 203-974-7349 | richard.schottenfeld@yale.edu |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D020399 | Practice Management |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
buprenorphine/naloxone |
|
| Educational Counseling | Other | Didactic, lecture-discussion format to supplement information and advice provided by physicians |
|
| Physician Management | Other | Brief physician counseling |
|
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
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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 |
| OG002 | 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 |
|
|
| Primary | Number of Opioid-negative Urine Toxicology Tests | 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. | 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. | Posted | Mean | Standard Deviation | opioid negative urine tests | 3 Months |
|
|
|
| Primary | Pain Interference | 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. | The analysis population is the intention to treat population and all observations across time periods were used in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 3 Months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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