← Back to Search

Other

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

Q: What conditions does the combination of PGB and LFX commonly combat?

<p>PGB/LFX is an efficacious remedy for managing <a href="https://www.withpower.com/clinical-trials/fibromyalgia">fibromyalgia</a>, <a href="https://www.withpower.com/clinical-trials/anxiety">anxiety</a> disorders, and vitamin b12 deficiency.</p>

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

Awards & highlights

PGB-LOF Trial 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

PGB-LOF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

withdrawal

Secondary outcome measures

complete detoxification

PGB-LOF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,998 Total Patients Enrolled

Stuart WatsonStudy DirectorOffice of Research Administration, Univ. of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this research project for participants?

"Affirmative, according to clinicaltrials.gov's data, this trial is actively looking for participants who can join the study as of December 20th 2020. The last time it was updated was on December 6th 2022 and 90 patients are needed from two different sites."

Answered by AI

What prior investigations have been conducted that utilized PGB/LFX?

"PGB/LFX was initially researched at Tel Aviv Sourasky Medical Center back in 2011, and since then 340 trials have been successfully concluded. Currently there are 25 active studies being held across the US, notably Philadelphia, Pennsylvania."

Answered by AI

What conditions does the combination of PGB and LFX commonly combat?

"PGB/LFX is an efficacious remedy for managing fibromyalgia, anxiety disorders, and vitamin b12 deficiency."

Answered by AI

What can be determined about the security of PGB/LFX for human consumption?

"Our team at Power has assigned a safety score of 2 to PGB/LFX, as this is only in Phase 2; meaning there exists evidence that it is safe, but not yet any proof of efficacy."

Answered by AI

How many participants are being accepted for inclusion in this clinical trial?

"Affirmative. Clinicaltrials.gov provides evidence that this research is currently recruiting participants; the trial was first published on December 20th 2020 and most recently updated on December 6th 2022, with a need for 90 patients across two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kyle Kampman 2020. "Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04218240.