St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin (UH3)
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|ClinicalTrials.gov Identifier: NCT04052139|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : December 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Alcohol Use, Unspecified HIV Infections||Drug: Low-dose naltrexone Drug: Gabapentin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems|
|Estimated Study Start Date :||April 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Active Comparator: Low-dose naltrexone
Participants randomized to this group will receive low dose naltrexone (4.5 mg) for 8 weeks.
Drug: Low-dose naltrexone
4.5 mg of low dose naltrexone taken once daily for 8 weeks. Participants in this group will also receive two matching placebo capsules to be taken twice daily with the active medication in weeks 1-3 and 8. In weeks 3-7, participants will take take 2 capsules three times per day (5 placebos, 1 active study medication) to match the the dosing regimen of the gabapentin arm. In week 7, participants will take two matching placebo capsules to be taken twice daily with the active medication (three capsules per day).
Active Comparator: Gabapentin
Participants randomized to this group will receive a dose of 900 mg gabapentin daily (300 mg tid), in week 2 the dose will be titrated up to 1800 mg daily (600 mg tid). In week 3, participants in the gabapentin arm will be titrated to 2700 mg daily (600 mg+300 mg tid) and will remain on the dose until week 7, when they will be tapered back down to 900 mg daily (days 1-3: 600 mg tid, days 4-7: 300 mg tid).
Dose will begin at 900 mg daily (300 mg tid), in week 2 the dose will be titrated up to 1800 mg daily (600 mg tid). In week 3, the dose will be titrated to 2700 mg daily (600 mg+300 mg tid) until week 7, and then tapered back down to 900 mg daily (days 1-3: 600 mg tid, days 4-7: 300 mg tid). Gabapentin will only be titrated up as tolerated by the participant.
Placebo Comparator: Placebo
Participants will receive a placebo to be taken three times daily for 8 weeks.
Capsule taken three times a day for 8 weeks in weeks 1-3 and 8. In week 3, dosing will change to 2 capsules three times per day until week 7. In week 7, participants will take three placebo capsules per day.
- Change in past week pain severity [ Time Frame: Endpoint at 8-weeks ]Change in past week pain severity (score 0-10) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory
- Change in past week pain interference [ Time Frame: Endpoint at 8-weeks ]Change in past week pain interference (score 0-10) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory
- Change in Biomarkers IL-6 and TNF-α between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]Levels of these pro-inflammatory markers will be measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems).
- Change in cold pain tolerance between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]This will be measured using the cold-pressor test; briefly it is the number of seconds a participant can keep hand submerged in cold water bath
- Change in percentage of past month heavy drinking days between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]Timeline Follow Back method will be used to assess drinks per day in the past 4 weeks. Using a calendar, participants provide retrospective estimates of their daily drinking over the past 30 days from the interview date.
- Change in measures of HIV control between baseline and week 8 [ Time Frame: Endpoint at 8-weeks ]CD4 cell counts and HIV viral loads will be measured on participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052139
|Contact: Jeffrey H. Samet, MD, MA, MPHfirstname.lastname@example.org|
|Contact: Judith I. Tsui, MD, MPHemail@example.com|
|First St. Petersburg Pavlov State Medical University|
|Saint Petersburg, Russian Federation|
|Contact: Evgeny Krupitsky, MD,PhD,DMdSc +7-812-365-2217 firstname.lastname@example.org|
|Principal Investigator:||Jeffrey H. Samet, MD, MA, MPH||Boston University/Boston Medical Center|