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NCT01863186 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
A Phase 3 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 3
- Development phase
- 603
- Enrollment target
NCT01863186: Completed Phase 3 study, sponsored by USWM, LLC (dba US WorldMeds).
NCT01863186 is a Phase 3 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 603 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01863186, a Phase 3 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 603 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind treatment portion where subjects will be randomly assigned to one of three doses of study medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or placebo) followed by an optional open-label treatment period where subjects will be inpatient or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal.
Primary Outcome
The SOWS-Gossop was completed by the mITT population subject at baseline, once daily at 3.5 hours after the first dose of the study medication on Days 1 to 7. It consists of 10 items that are scored on a 4-point scale; 0=none, 1=mild, 2=moderate, and 3=severe. The overall score is the simple sum of the 10-item scores (minimum overall score of 0, maximum score of 30). Higher individual scores on the scale indicate greater symptom severity. However, as the outcome measure is a difference from plac
Interventions
- DRUG Placebo
- DRUG Lofexidine HCl
- DRUG Open Label Lofexidine HCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01863186 record still lists
NCT01863186 is an interventional study that assigns participants to a tested intervention. The registered 603 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01863186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01863186 about?
NCT01863186 is a clinical study titled "Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal". The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind treatment portion where subj...
What is the current status of trial NCT01863186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 603 participants. The study started on 2013-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01863186?
The interventions under investigation include: Placebo (DRUG), Lofexidine HCl (DRUG), Open Label Lofexidine HCL (DRUG).
Who is sponsoring clinical trial NCT01863186?
This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01863186's enrollment target sits among peer trials
603 607th of 2000 higher than 1,394 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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