Lofexidine + Pregabalin for Opioid Withdrawal (UH3 Trial)

Phase 2

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days per subject, through study completion (n=150)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a combination of lofexidine and pregabalin can help people with an opioid use disorder manage withdrawal and start using XR-NTX.

Who is the study for?

This trial is for adults over 18 with opioid use disorder who've used opioids on most days in the past month and are interested in naltrexone treatment. They must have a stable address, no severe medical or psychiatric conditions, not be pregnant or breastfeeding, and meet specific heart health criteria.

What is being tested?

The study tests if combining lofexidine with pregabalin (LFX/PGB) or its placebo (LFX/PLA-PGB) helps manage withdrawal symptoms in outpatients seeking to start extended-release injectable naltrexone therapy. Participants are randomly assigned to one of these two groups.

What are the potential side effects?

Possible side effects include dizziness, sleepiness, dry mouth from lofexidine; and drowsiness, weight gain, blurred vision from pregabalin. The combination may also cause low blood pressure or slow heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days per subject, through study completion (n=150)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 days per subject, through study completion (n=150)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days per subject, through study completion (n=150) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Subjective Opioid Withdrawal Scale (SOWS) scores

Secondary study objectives

Study detox completion

XR-NTX IM injection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LFX/PGBExperimental Treatment2 Interventions

PGB/day 1=400mg, day 2-7=600mg each day, day 8=400mg, day 9=200mg, day 10=100mg LFX/day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg

Group II: LFX/PLA-PGBActive Control2 Interventions

PLA-PGB/day 1-7= 0mg each day, day 8, 9, and 10 =0mg each day LFX/ day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg

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