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NCT01571167 · ClinicalTrials.gov registry record · Phase 1
Varenicline as a Treatment for Methamphetamine Dependence
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01571167: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT01571167 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01571167, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary purpose of the study is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
Primary Outcome
The safety of MA administration during treatment will be assessed by reporting of adverse events (AEs), and using ECG recording, and heart rate and blood pressure measurements. Digital 12-lead ECG will also be recorded prior to randomization. Blood pressure and heart rate will be measured from 15 min prior to MA or placebo dosing until 2 h after dosing. In addition, heart rate and blood pressure will be assessed throughout the inpatient portion of the protocol.
Interventions
- DRUG Placebo
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01571167 record still lists
NCT01571167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01571167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01571167 about?
NCT01571167 is a clinical study titled "Varenicline as a Treatment for Methamphetamine Dependence". The primary purpose of the study is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
What is the current status of trial NCT01571167?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-01. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01571167?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG).
Who is sponsoring clinical trial NCT01571167?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01571167's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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