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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
UH3 Trial 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.Check my eligibility
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.See study design
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.
UH3 Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjective Opioid Withdrawal Scale (SOWS) scores
Secondary outcome measures
Study detox completion
XR-NTX IM injection
UH3 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
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures, not including childhood febrile seizures.I am currently on medication for diabetes or using drugs that stimulate my heart and nervous system.I am currently taking opioids for pain.My heart's electrical activity is within safe ranges for the study.My liver function is severely impaired.I am 18 years old or older.I am not pregnant and am using effective birth control.I am currently taking medication that strongly affects how my body processes certain drugs.
Research Study Groups:
This trial has the following groups:- Group 1: LFX/PGB
- Group 2: LFX/PLA-PGB
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree are people exposed to risks when using LFX/PGB?
"Due to the limited efficacy data, our team at Power assigned LFX/PGB a score of 2 on its safety scale. Nevertheless, there is some evidence that supports its security profile."
Answered by AI
Is the recruitment phase of this trial still open?
"Clinicaltrials.gov confirms that, initially posted on September 1st of 2023 and last updated August 15th of the same year, this trial is no longer seeking participants. Despite that fact, 154 other clinical trials are currently recruiting volunteers to test their medications."
Answered by AI
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