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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: Completed Phase 2 study of Smoking Cessation and Smoking, sponsored by University of Chicago.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Conditions Studied
Interventions
- DRUG Naltrexone (drug)
- DRUG Placebo (for Naltrexone)
Study Locations (1)
Illinois
- The University of Chicago, Department of Psychiatry - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2005-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00271024 record still lists
NCT00271024 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (30% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00271024's enrollment target sits among peer trials
333 74th of 188 higher than 115 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation 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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