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NCT00142909 · ClinicalTrials.gov registry record · Phase 2

Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
86
Enrollment target

NCT00142909: Completed Phase 2 study, sponsored by Yale University.

NCT00142909 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00142909, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
86 participants
Enrollment target

Study Summary

Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to determine whether lofexidine in combination with naltrexone can improve an individual's ability to cope with stress and subsequently increase the chances of remaining abstinent from opiates.

Primary Outcome

The Subjective Opiate Withdrawal Scale (SOWS) consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. The greater the score, the greater the intensity of Opiate Withdrawal. Source: Reprinted from Handelsman et al. 1987, p. 296, by courtesy of Marcel Dekker, Inc.Other Sources: Gossop 1990; Bradley et al. 1987. ACCESSED: h

Interventions

  • DRUG Placebo
  • DRUG Lofexidine

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2005-02
Est. Completion 2009-01
Phase Phase 2
Yale University

1,492 total trials

What the finished NCT00142909 record still lists

NCT00142909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).

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

NCT00142909 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00142909 about?

NCT00142909 is a clinical study titled "Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1". Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to determine whether lofexidine in combination with naltrexone can improve an individual's ability to cope with stress ...

What is the current status of trial NCT00142909?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2005-02. Estimated completion is 2009-01.

What interventions are being tested in trial NCT00142909?

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

Who is sponsoring clinical trial NCT00142909?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00142909's enrollment target sits among peer trials

86 812th of 2000 higher than 1,181 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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Source: ClinicalTrials.gov NCT00142909, the US trial registry maintained by the National Library of Medicine. NCT00142909 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.