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
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 7 days
7 days
complete detoxification
withdrawal
Trial Safety
Safety Progress
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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Conditions
Cancer Related
Treatments