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NCT01019707 · ClinicalTrials.gov registry record · Phase 1

Safety Assessment of Atomoxetine With MA IV Administration

A Phase 1 study, sponsored by University of California, Los Angeles.

Terminated
Registry status
Phase 1
Development phase
6
Enrollment target

NCT01019707: Clinical Trial Phase 1 study, sponsored by University of California, Los Angeles.

NCT01019707 is a Phase 1 study that was terminated before completion, run by University of California, Los Angeles. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01019707, a Phase 1 study, was terminated before completion, sponsored by University of California, Los Angeles.

TERMINATED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine. MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the participants to proceed with the study they will participate in two inpatient components of the study that will occur in the University of California Los Angeles (UCLA) General Clinical Research Center (GCRC). The first inpatient stay will be 15 days, and the second will be a 9 days stay that includes drug administration and assessments. There will be at least a two week interval between inpatient components. During the inpatient components participants will receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA administration or saline.

Primary Outcome

Based on 8 timepoints post MA infusion, data were pooled and the mean value and standard deviation are presented. Timepoints assessed were collected at 2, 5, 10, 15, 30, 45, 60, 90 minutes following infusion.

Interventions

  • DRUG Atomoxetine, then Placebo
  • DRUG Placebo, then Atomoxetine

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2009-10
Est. Completion 2010-12
Phase Phase 1

Why NCT01019707 stopped before completion

NCT01019707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Atomoxetine, then Placebo is the first listed.

NCT01019707 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01019707 about?

NCT01019707 is a clinical study titled "Safety Assessment of Atomoxetine With MA IV Administration". This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine. MA abusing participants will undergo a 1-day outpatien...

What is the current status of trial NCT01019707?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2009-10. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01019707?

The interventions under investigation include: Atomoxetine, then Placebo (DRUG), Placebo, then Atomoxetine (DRUG).

Who is sponsoring clinical trial NCT01019707?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01019707's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 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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Source: ClinicalTrials.gov NCT01019707, the US trial registry maintained by the National Library of Medicine. NCT01019707 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.