drugset / Trial / NCT04052139
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Phase 2
Completed
45 enrolled
Boston Medical Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
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).
Timeline
- Start
- 2021-01-25
- Primary completion
- 2021-11-16
- Completion
- 2021-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gabapentin | Small molecule | 1800 mg | — |
| Comparator | Naltrexone | Small molecule | 4.5 mg | — |