PGB/LFX; for Opioid Withdrawal Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Opioid Withdrawal SyndromePregabalin 200 MG capsules - Drug
Eligibility
18+
All Sexes
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Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 7 days

7 days
complete detoxification
withdrawal

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Lofexidine and PLACEBO
1 of 2
PGB/LFX;
1 of 2

Active Control

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: PGB/LFX; · Has Placebo Group · Phase 2

PGB/LFX;Experimental Group · 2 Interventions: Pregabalin 200 MG capsules, Lofexidine 0.18Mg Tab · Intervention Types: Drug, Drug
Lofexidine and PLACEBOActiveComparator Group · 2 Interventions: Lofexidine 0.18Mg Tab, Placebo oral tablet · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,844 Previous Clinical Trials
41,137,998 Total Patients Enrolled
Stuart WatsonStudy DirectorOffice of Research Administration, Univ. of Pennsylvania

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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