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PGB/LFX; for Opioid Withdrawal Syndrome (PGB-LOF Trial)

Phase 2
Waitlist Available
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 7 days

Summary

This trial will investigate whether pregabalin combined with lofexidine can reduce opioid withdrawal-related subjective effects and increase the proportion of patients with an opioid use disorder who complete detoxification and transition to antagonist treatment with extended-release injectable naltrexone.

Eligible Conditions
  • Opioid Withdrawal Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days 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-Gossop (SOWS) Scale Score
Secondary study objectives
Completion of Withdrawal Management

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PGB/LFX;Experimental Treatment2 Interventions
0.54 mg lofexidine and 200 mg Pregabalin on days 1 -7 with taper for pregabalin and lofexidine starting on day 5
Group II: Lofexidine and PLACEBOActive Control2 Interventions
0.54 mg lofexidine and Placebo (PLB) on days 1-7 with taper for lofexidine starting on day 5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lofexidine 0.18Mg Tab
2020
Completed Phase 2
~90
Pregabalin 200 MG capsules
2020
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,076 Previous Clinical Trials
42,719,735 Total Patients Enrolled
Stuart WatsonStudy DirectorOffice of Research Administration, Univ. of Pennsylvania
~18 spots leftby Nov 2025
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