Trials / Recruiting
RecruitingNCT05995535
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.
Detailed description
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal. It follows a UG3 study in which 90 inpatients with an OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were equally safe, and that lofexidine/pregabalin was more effective in reducing subjective withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin. The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient settings.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LFX/PGB | lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg |
| DRUG | LFX/PLA-PGB | lofexidine tablets 0.18mg tabs pregabalin capsules 0mg |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
- First posted
- 2023-08-16
- Last updated
- 2026-02-13
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05995535. Inclusion in this directory is not an endorsement.