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NCT00000437 · ClinicalTrials.gov registry record · Phase 4

Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

A Phase 4 study, sponsored by The Scripps Research Institute.

Completed
Registry status
Phase 4
Development phase
60
Enrollment target

NCT00000437: Completed Phase 4 study, sponsored by The Scripps Research Institute.

NCT00000437 is a Phase 4 study that has completed, run by The Scripps Research Institute. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000437, a Phase 4 study, has completed, sponsored by The Scripps Research Institute.

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target

Study Summary

The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

Interventions

  • DRUG Naltrexone Tablet and Nicotine Patch
  • DRUG Naltrexone Tablet and Placebo Patch
  • DRUG Placebo Tablet and Nicotine Patch
  • DRUG Placebo Tablet and Placebo Patch

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 1997-09-26
Est. Completion 2005-09-15
Phase Phase 4
The Scripps Research Institute

16 total trials

What the finished NCT00000437 record still lists

NCT00000437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 4 interventions - of which Naltrexone Tablet and Nicotine Patch is the first listed.

NCT00000437 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000437 about?

NCT00000437 is a clinical study titled "Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)". The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

What is the current status of trial NCT00000437?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 1997-09-26. Estimated completion is 2005-09-15.

What interventions are being tested in trial NCT00000437?

The interventions under investigation include: Naltrexone Tablet and Nicotine Patch (DRUG), Naltrexone Tablet and Placebo Patch (DRUG), Placebo Tablet and Nicotine Patch (DRUG), Placebo Tablet and Placebo Patch (DRUG).

Who is sponsoring clinical trial NCT00000437?

This trial is sponsored by The Scripps Research Institute, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000437's enrollment target sits among peer trials

60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00000437, the US trial registry maintained by the National Library of Medicine. NCT00000437 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.