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NCT00271024 · ClinicalTrials.gov registry record · Phase 2

Efficacy of Naltrexone in Women's Smoking Cessation

A Phase 2 study of Smoking Cessation and Smoking, sponsored by University of Chicago.

Completed
Registry status
Phase 2
Development phase
333
Enrollment target
1
Study location

NCT00271024 is a Phase 2 study of Smoking Cessation and Smoking that has completed, run by University of Chicago. The registered enrollment target is 333 participants, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00271024, a Phase 2 study of Smoking Cessation and Smoking, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
333 participants
Enrollment target
1
Study location

Study Summary

The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Hypotheses: 1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year). 2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome. 3. These effects are predicted to be stronger in women compared to men.

Interventions

  • DRUG Naltrexone (drug)
  • DRUG Placebo (for Naltrexone)

Study Locations (1)

Illinois

  • The University of Chicago, Department of Psychiatry - Chicago

Trial Details

FieldValue
Enrollment Target 333 participants
Start Date 2005-12
Est. Completion 2010-03
Phase Phase 2

Sponsor

University of Chicago

796 total trials

What the Registry Record Tells You About NCT00271024

The ClinicalTrials.gov registry entry for NCT00271024 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (30% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which Naltrexone (drug) is the first listed.

NCT00271024 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT00271024 about?

NCT00271024 is a clinical study titled "Efficacy of Naltrexone in Women's Smoking Cessation". The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Hypotheses: 1. Naltrexone will improve smoking ...

What is the current status of trial NCT00271024?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 333 participants. The study started on 2005-12. Estimated completion is 2010-03.

What conditions does trial NCT00271024 study?

This clinical trial studies the following conditions: Smoking Cessation, Smoking.

What interventions are being tested in trial NCT00271024?

The interventions under investigation include: Naltrexone (drug) (DRUG), Placebo (for Naltrexone) (DRUG).

Who is sponsoring clinical trial NCT00271024?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00271024 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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