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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA015616 | U.S. NIH Grant/Contract | View source | |
| R03DA029768 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Methadone 10-60 mg per day in 2-4 divided doses for 6 months |
|
| 2 | Experimental | Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Oral, 10-60 mg per day, 2-4 times per day, 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Retained in Treatment | This outcome assesses the number of participants who completed the treatment after 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Score for Pain | Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible. | 6 months |
| Numerical Rating Score for Functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Blondell, MD | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheehan Memorial Hospital | Buffalo | New York | 14203 | United States | ||
| Erie County Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36063082 | Derived | Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3. | |
| 23480249 | Derived | Neumann AM, Blondell RD, Jaanimagi U, Giambrone AK, Homish GG, Lozano JR, Kowalik U, Azadfard M. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78. doi: 10.1080/10550887.2012.759872. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone | Methadone 10-60 mg per day in 2-4 divided doses for 6 months |
| FG001 | Buprenorphine/Naloxone | Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone | Methadone 10-60 mg per day in 2-4 divided doses for 6 months |
| BG001 | Buprenorphine/Naloxone | Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) |
| 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 | Number of Participants Retained in Treatment | This outcome assesses the number of participants who completed the treatment after 6 months. | All participants that were randomized were analyzed regarding their retention in treatment at 6 months. | Posted | Number | participants | 6 months |
|
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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 | Methadone | Methadone 10-60 mg per day in 2-4 divided doses for 6 months |
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small subject number not a double-blind study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Blondell | SUNY Buffalo | 716-898-4971 | blondell@buffalo.edu |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D002047 | Buprenorphine |
| D009019 | Morphinans |
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| Buprenorphine/naloxone | Drug | Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months |
|
|
We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.
| 6 months |
| Self-reported Illicit Opioid Use | 6 months |
| Buffalo |
| New York |
| 14215 |
| United States |
| Physician Decision |
|
| psychiatric problem |
|
| put on parole |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Numerical Rating Score for Pain | Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible. | Participants that completed the treatment at 6 months were analyzed. | Posted | Mean | Standard Deviation | units on a 0-10 NRS scale | 6 months |
|
|
|
|
| Secondary | Numerical Rating Score for Functioning | We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning. | The participants who completed the treatment were included in the statistical analysis. | Posted | Mean | Standard Deviation | units on a 0-10 point NRS scale | 6 months |
|
|
|
|
| Secondary | Self-reported Illicit Opioid Use | Posted | Number | number of participants | 6 months |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Buprenorphine/Naloxone | Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) | 0 | 26 | 0 | 26 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D053610 |
| Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |