NCT04218240

Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal

Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

An inpatient detoxification study where pregabalin (PBG) will be given orally at a starting dose of up to 600 mg daily (group 1) tapered to 100 mg daily over 7 days; given with lofexidine (LFX) starting at 2.16 mg daily and declining to 0.72 mg over 7 days. On day 8, subjects are offered an injection of XR-NTX if they provide a urine sample that is negative for opioids and buprenorphine and pass a naloxone challenge. All subjects, regardless of whether or not they receive XR-NTX, will be given a referral and appointment for follow-up treatment when they leave the inpatient detoxification program.

Conditions

• Opioid Withdrawal

Interventions

Type	Name	Description
DRUG	Pregabalin 200 MG capsules	oral pregabalin 200 mg capsules given with a taper on day 5
DRUG	Placebo oral tablet	oral Placebo
DRUG	Lofexidine 0.18Mg Tab	lofexidine 0.18 tab given with a taper starting on day 5

Timeline

• Start date: 2020-12-17
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2020-01-06
• Last updated: 2024-09-19
• Results posted: 2024-05-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study