A Phase 2 interventional study of Low-dose naltrexone and Gabapentin in Chronic Pain, Alcohol Use, Unspecified and HIV Infections, sponsored by Boston Medical Center. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Boston Medical Center · Phase 2, Interventional, and Treatment
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).
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Drug: Low-dose naltrexone
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).
Drug: Gabapentin
Participants will receive a placebo to be taken three times daily for 8 weeks.
Drug: Placebo
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.
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).
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.
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
Time frame: 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
Time frame: Baseline, 8-weeks
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.
Time frame: Baseline, 8-weeks
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.
Time frame: Baseline, 8-weeks
Change in CD4 Count
Defined as mean change in CD4 values from lab assay
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 8-weeks
| Milestone | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| 4-weeks | 14 | 15 | 15 |
| 8-weeks | 12 | 15 | 15 |
| 12-weeks | 12 | 15 | 15 |
| Completed | 12 | 15 | 15 |
| Not completed | 3 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
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
| units on a scale | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in Past Week Pain Severity | -0.97 ± 0.63 | -2.12 ± 0.38 | -1.85 ± 0.61 |
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
| units on a scale | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in Past Week Pain Interference | -1.73 ± 0.47 | -1.97 ± 0.64 | -2.14 ± 0.58 |
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.
| seconds | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in Cold Pain Tolerance | -14.78 ± 7.61 | -3.33 ± 4.56 | -3.15 ± 6.89 |
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.
| % of change in heavy drinking days | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in Percentage of Past Month Heavy Drinking Days | 3.07 ± 5.17 | -4.22 ± 2.07 | -4.63 ± 4.64 |
Defined as mean change in CD4 values from lab assay
| cell/mm^3 | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in CD4 Count | 15.85 ± 74.96 | -106.47 ± 64.94 | -52.13 ± 82.43 |
Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests
| Participants | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Number of Participants With a Change in HIV Viral Load Suppression Status | 1 | 0 | 0 |
Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
| pg/ml | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in Biomarker IL-6 | -0.12 ± 0.19 | 0.04 ± 0.12 | 0.29 ± 0.14 |
Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
| pg/ml | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in Biomarker IL-10 | -0.13 ± 0.25 | 0.07 ± 0.16 | -0.26 ± 0.23 |
Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
| pg/ml | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in TNF-alpha | 0.27 ± 0.31 | 0.47 ± 0.15 | 0.21 ± 0.42 |
Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R\&D Systems).
| pg/ml | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| Change in IL-1beta | 0.30 ± 0.22 | 0.95 ± 0.29 | 0.41 ± 0.20 |
Collected over Adverse event data were collected from baseline to 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low-dose Naltrexone | 0/15 (0%) | 1/15 (6.7%) | 4/15 (26.7%) |
| Gabapentin | 0/15 (0%) | 0/15 (0%) | 5/15 (33.3%) |
| Placebo | 0/15 (0%) | 1/15 (6.7%) | 2/15 (13.3%) |
| Event | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| SeizureNervous system disorders | 1/15 | 0/15 | 0/15 |
| Surgery for Acute purulent non-lactation mastitis on the left sideReproductive system and breast disorders | 0/15 | 0/15 | 1/15 |
| Event | Low-dose Naltrexone | Gabapentin | Placebo |
|---|---|---|---|
| FatigueGeneral disorders | 3/15 | 0/15 | 1/15 |
| HypertensionCardiac disorders | 1/15 | 0/15 | 0/15 |
| DiarrheaGastrointestinal disorders | 1/15 | 0/15 | 0/15 |
| Stomach painGastrointestinal disorders | 1/15 | 0/15 | 0/15 |
| Loss of appetiteGastrointestinal disorders | 1/15 | 0/15 | 1/15 |
| Abdominal painGastrointestinal disorders | 0/15 | 1/15 | 0/15 |
| FlatulenceGastrointestinal disorders | 0/15 | 1/15 | 0/15 |
| DizzinessNervous system disorders | 1/15 | 0/15 | 0/15 |
| Speech impedimentNervous system disorders | 1/15 | 0/15 | 0/15 |
| TremorNervous system disorders | 1/15 | 0/15 | 0/15 |
| Age, Continuous(years) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| Mean | 40 ± 6 | 41 ± 7 | 41 ± 7 | 41 ± 7 |
| Sex: Female, Male(Participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| Female | 6 | 5 | 5 | 16 |
| Male | 9 | 10 | 10 | 29 |
| Ethnicity (NIH/OMB)(Participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 15 | 15 | 45 |
| Race (NIH/OMB)(Participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 15 | 15 | 45 |
| Region of Enrollment(participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| Russia | 15 | 15 | 15 | 45 |
| Education - 9 grades or more(Participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| Count of participants | 15 | 15 | 15 | 45 |
| Marital status(Participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| Married/living with partner/long-term relationship | 5 | 11 | 6 | 22 |
| Never married/divorced/widowed/separated | 10 | 4 | 9 | 23 |
| Harmful or hazardous drinking (AUDIT)(Participants) | Low-dose Naltrexone | Gabapentin | Placebo | Total |
|---|---|---|---|---|
| AUDIT score <8 | 5 | 6 | 7 | 18 |
| AUDIT score 8+ | 10 | 9 | 8 | 27 |
15 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All data from the study will be placed into the URBAN ARCH repository.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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