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| ID | Type | Description | Link |
|---|---|---|---|
| UH3AA026193 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).
Pain is a common co-morbidity for HIV-positive patients.Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-positive persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. It is timely and relevant to conduct research on gabapentin, as it has emerged as one of the most commonly prescribed non-opioid medications for pain despite the fact that gabapentin is only FDA approved for "post-herpetic neuralgia" and the literature to support its use for generalized chronic pain is limited. And yet, gabapentin has demonstrated benefits for treatment of alcohol use disorder, and therefore, like naltrexone, it could have a specific role for treating patients with chronic pain and unhealthy alcohol use. This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin vs. placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain (both self-reported and experimental/cold pressor test; 2) inflammation (i.e., levels of inflammatory cytokines IL-6, IL-1β, IL-10, and TNF-α); and 3) measures of HIV control (CD4 count and viral load).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose naltrexone | Active Comparator | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. |
|
| Gabapentin | Active Comparator | Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). |
|
| Placebo | Placebo Comparator | Participants will receive a placebo to be taken three times daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose naltrexone | Drug | 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Past Week Pain Severity | Change in past week pain severity (score 0 [no pain] -10 [high pain]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function | Baseline, 8-weeks |
| Change in Past Week Pain Interference | Change in past week pain interference (score 0 [no pain]-10 [high pain]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function | Baseline, 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cold Pain Tolerance | Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes. | Baseline, 8-weeks |
| Change in Percentage of Past Month Heavy Drinking Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey H. Samet, MD, MA, MPH | Boston University/Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First St. Petersburg Pavlov State Medical University | Saint Petersburg | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38408060 | Derived | Tsui JI, Rossi SL, Cheng DM, Bendiks S, Vetrova M, Blokhina E, Winter M, Gnatienko N, Backonja M, Bryant K, Krupitsky E, Samet JH. Pilot RCT comparing low-dose naltrexone, gabapentin and placebo to reduce pain among people with HIV with alcohol problems. PLoS One. 2024 Feb 26;19(2):e0297948. doi: 10.1371/journal.pone.0297948. eCollection 2024. |
| Label | URL |
|---|---|
| URBAN ARCH, a member of NIAAA CHAART (Consortiums for HIV/AIDS \& Alcohol Research Translation) initiative, conducts and disseminates interdisciplinary research on how alcohol impacts people with HIV and develops interventions to reduce related outcomes. | View source |
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All data from the study will be placed into the URBAN ARCH repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low-dose Naltrexone | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily. |
| FG001 | Gabapentin | Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). |
| FG002 | Placebo | Participants will receive a placebo to be taken three times daily for 8 weeks. Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low-dose Naltrexone | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Past Week Pain Severity | Change in past week pain severity (score 0 [no pain] -10 [high pain]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function | Posted | Mean | Standard Error | units on a scale | Baseline, 8-weeks |
|
Adverse event data were collected from baseline to 12 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 | Low-dose Naltrexone | Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks. Low-dose naltrexone: 4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey H. Samet | Boston Medical Center | 617-414-7288 | jsamet@bu.edu |
Not provided
| 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 | Mar 24, 2021 | Jul 16, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2021 | Jan 13, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000428 | Alcohol Drinking |
| D015658 | HIV Infections |
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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|
| Gabapentin | Drug | Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). |
|
| Placebo | Drug | In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients. |
|
Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (> 4 drinks in a day for men; > 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days. |
| Baseline, 8-weeks |
| Change in CD4 Count | Defined as mean change in CD4 values from lab assay | Baseline, 8-weeks |
| Number of Participants With a Change in HIV Viral Load Suppression Status | Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests | Baseline, 8-weeks |
| Change in Biomarker IL-6 | Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Baseline, 8-weeks |
| Change in Biomarker IL-10 | Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Baseline, 8 weeks |
| Change in TNF-alpha | Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Baseline, 8-weeks |
| Change in IL-1beta | Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Baseline, 8-weeks |
| BG001 | Gabapentin | Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). |
| BG002 | Placebo | Participants will receive a placebo to be taken three times daily for 8 weeks. Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education - 9 grades or more | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Harmful or hazardous drinking (AUDIT) | Number of participants with harmful/hazardous drinking. Measured via the Alcohol Use Disorders Identification Test (AUDIT). A score of 8 or greater refers to harmful/hazardous drinking. Scores range from 0 (abstainer) to 40. | Count of Participants | Participants |
|
| Number of heavy drinking days in past 30 days | Mean number of heavy drinking days in past 30 days. Measured via the Timeline Follow-back for past 30 days. Heavy drinking defined as > 4 drinks in a day for men; > 3 drinks in a day for women. | Mean | Standard Deviation | days |
|
| Past month heavy drinking days (%) | Mean (%) past month heavy drinking days. Measured via the Timeline Follow-back for past 30 days. Number of heavy drinking days divided by 30. Heavy drinking defined as > 4 drinks in a day for men; > 3 drinks in a day for women. | Mean | Standard Deviation | % days |
|
| Lifetime opioid use | Number of participants who have used at least one listed opioid in their lifetime (heroin, methadone, other opioid [codeine, china white, fentanyl, Khanka] by itself, krokodil, heroin mixed with stimulants [Jeff, ephedrine, amphetamine, methamphetamine, cocaine or crack]). | Count of Participants | Participants |
|
| Past week pain severity | Mean past week pain severity (score 0 [no pain] -10 [high pain]). Pain severity will be measured using the Brief Pain Inventory | Mean | Standard Deviation | units on a scale |
|
| Past week pain interference | Mean past week pain interference (score 0 [no pain] -10 [high pain]). Pain interference will be measured using the Brief Pain Inventory | Mean | Standard Deviation | units on a scale |
|
| Cold pain threshold | Mean number of seconds until a participant feels pain while their hand in submerged in a container of iced water. Participants were instructed to let the research assessor know when they first felt pain. | Mean | Standard Deviation | seconds |
|
| Cold pain tolerance | Mean number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes. | Mean | Standard Deviation | seconds |
|
| IL-6 biomarker | Mean IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Mean | Standard Deviation | pg/ml |
|
| IL-10 biomarker | Mean IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Mean | Standard Deviation | pg/ml |
|
| TNF-alpha biomarker | Mean TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Mean | Standard Deviation | pg/ml |
|
| IL-1-beta biomarker | Mean IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Mean | Standard Deviation | pg/ml |
|
| HIV viral load suppression | Number of participants with suppressed HIV viral load (<250 copies/ml) and unsuppressed HIV viral load (250+ copies/ml) | Count of Participants | Participants |
|
| CD4 count | Mean CD4 values | Mean | Standard Deviation | cell/mm^3 |
|
| Depressive symptoms | Number of participants with depressive symptoms, measured with the Center for Epidemiologic Studies Depression Scale (CES-D). Depressive symptoms indicated as a score of 16 or above. | Count of Participants | Participants |
|
| Anxiety | Number of participants with anxiety, measured with the General Anxiety Disorder-7 (GAD-7). Minimal anxiety indicated as a score of 0 to 4; mild anxiety as 5 to 9; moderate anxiety at 10 to 14; and severe anxiety at 15 to 21. Possible scores range from 0 (no anxiety) to 21. | Count of Participants | Participants |
|
| OG001 | Gabapentin | Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). |
| OG002 | Placebo | Participants will receive a placebo to be taken three times daily for 8 weeks. Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients. |
|
|
| Primary | Change in Past Week Pain Interference | Change in past week pain interference (score 0 [no pain]-10 [high pain]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function | Posted | Mean | Standard Error | units on a scale | Baseline, 8-weeks |
|
|
|
| Secondary | Change in Cold Pain Tolerance | Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes. | Posted | Mean | Standard Error | seconds | Baseline, 8-weeks |
|
|
|
| Secondary | Change in Percentage of Past Month Heavy Drinking Days | Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (> 4 drinks in a day for men; > 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days. | Posted | Mean | Standard Error | % of change in heavy drinking days | Baseline, 8-weeks |
|
|
|
| Secondary | Change in CD4 Count | Defined as mean change in CD4 values from lab assay | Posted | Mean | Standard Error | cell/mm^3 | Baseline, 8-weeks |
|
|
|
| Secondary | Number of Participants With a Change in HIV Viral Load Suppression Status | Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests | Posted | Count of Participants | Participants | Baseline, 8-weeks |
|
|
|
| Secondary | Change in Biomarker IL-6 | Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Posted | Mean | Standard Error | pg/ml | Baseline, 8-weeks |
|
|
|
| Secondary | Change in Biomarker IL-10 | Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Posted | Mean | Standard Error | pg/ml | Baseline, 8 weeks |
|
|
|
| Secondary | Change in TNF-alpha | Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Posted | Mean | Standard Error | pg/ml | Baseline, 8-weeks |
|
|
|
| Secondary | Change in IL-1beta | Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). | Posted | Mean | Standard Error | pg/ml | Baseline, 8-weeks |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 4 |
| 15 |
| EG001 | Gabapentin | Participants randomized to the gabapentin arm begin on a dose of 300 mg daily (300 mg qd). In week 2, participants will take 300 mg of gabapentin three times daily. In week 3 the dose will be titrated up to 1800 mg daily (300 mg+300 mg tid) will remain on the dose until week 8, when they will be tapered back down to 900 mg daily (300 mg tid). In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). Gabapentin: Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily). | 0 | 15 | 0 | 15 | 5 | 15 |
| EG002 | Placebo | Participants will receive a placebo to be taken three times daily for 8 weeks. Placebo: In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients. | 0 | 15 | 1 | 15 | 2 | 15 |
| Surgery for Acute purulent non-lactation mastitis on the left side | Reproductive system and breast disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Loss of appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Speech impediment | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Sleepiness | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Cold | Infections and infestations | Systematic Assessment |
|
| Burning in the legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Redness of the skin of the upper body | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| Heterocyclic Compounds |
| 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 |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |