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NCT03718065 · ClinicalTrials.gov registry record · Phase 2
Impact of Lofexidine on Stress, Craving and Opioid Use
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT03718065: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT03718065 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03718065, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment.
Primary Outcome
Participants will rate craving on a 0 to 7 Likert scale with 0 indicate "Strongly disagree" that they crave and 7 indicating "strongly agree" that they crave so that higher scores indicate more craving.
Interventions
- DRUG Placebo
- DRUG Lofexidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 2 |
What the finished NCT03718065 record still lists
NCT03718065 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03718065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03718065 about?
NCT03718065 is a clinical study titled "Impact of Lofexidine on Stress, Craving and Opioid Use". Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app...
What is the current status of trial NCT03718065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2019-06-26. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT03718065?
The interventions under investigation include: Placebo (DRUG), Lofexidine (DRUG).
Who is sponsoring clinical trial NCT03718065?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03718065's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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