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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA036564-01 | U.S. NIH Grant/Contract | View source |
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End of NIH funding
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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Combination of guanfacine with opioid medication as a standard treatment for chronic pain.
This aim proposes that guanfacine would be a useful drug to reverse Opioid-Induced Hyperalgesia (OIH) when combined with opioids in chronic pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanfacine (2mg) | Active Comparator | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. |
|
| Guanfacine (1mg) | Active Comparator | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. |
|
| Placebo | Placebo Comparator | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanfacine | Drug | Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Score (0-10: 0 Being no Pain; 10 Being the Worst Pain) | Changes in numeric pain score (as indicated in Outcome Measure Title) will be used to compare the 3 treatment groups. | baseline and 4 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jianren Mao, M.D., Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Center for Translational Pain Research | Boston | Massachusetts | 02114 | United States |
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| Label | URL |
|---|---|
| MGH Center for Translational Pain Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Guanfacine (2mg) | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
| FG001 | Guanfacine (1mg) | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
| FG002 | Placebo | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guanfacine (2mg) | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
| 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 | Numeric Pain Score (0-10: 0 Being no Pain; 10 Being the Worst Pain) | Changes in numeric pain score (as indicated in Outcome Measure Title) will be used to compare the 3 treatment groups. | Posted | Mean | Standard Deviation | score on a scale | baseline and 4 weeks |
|
4 weeks
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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 | Guanfacine (2mg) | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jianren Mao | MassGH | 6177268810 | jmao@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2013 | Jun 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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|
|
| Placebo | Drug | Subjects will be randomized into 1 of the following 3 treatment groups:
|
|
|
| BG001 | Guanfacine (1mg) | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
| BG002 | Placebo | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). |
| OG002 | Placebo | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Guanfacine (1mg) | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Guanfacine: Subjects will be randomized into 1 of the following 3 treatment groups:
To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo). | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Placebo | Subjects will be randomized into 1 of the following 3 treatment groups:
Subjects will be instructed to take one capsule in the evening for 4 weeks. Placebo: Subjects will be randomized into 1 of the following 3 treatment groups:
| 0 | 1 | 0 | 1 | 0 | 1 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002241 | Carbohydrates |