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NCT01438749 · ClinicalTrials.gov registry record · Phase 1
A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users
A Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 177
- Enrollment target
- 1
- Study location
NCT01438749: Completed Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
NCT01438749 is a Phase 1 study of Healthy Volunteer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 177 participants, below the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01438749, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 177 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO4917838
- DRUG diazepam
Study Locations (1)
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01438749 record still lists
NCT01438749 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01438749 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01438749 about?
NCT01438749 is a clinical study titled "A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users". This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of...
What is the current status of trial NCT01438749?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 177 participants. The study started on 2011-10. Estimated completion is 2012-05.
What conditions does trial NCT01438749 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT01438749?
The interventions under investigation include: Placebo (DRUG), RO4917838 (DRUG), diazepam (DRUG).
Who is sponsoring clinical trial NCT01438749?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01438749 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01438749's enrollment target sits among peer trials
177 22nd of 112 higher than 91 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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