drugset / Trial / NCT04218240
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
RandomizedParallel-groupTriple-blindTreatment
Summary
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective effects, and investigate, whether the PGB/LFX combination can increase the proportion of patients with an opioid use disorder (OUD) who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone (XR-NTX).
Timeline
- Start
- 2020-12-17
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 200 mg | Oral |
| Background | Lofexidine | Small molecule | 0.54 mg | — |