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NCT00270231 · ClinicalTrials.gov registry record · Phase 2
Effects of Naltrexone on Nicotine Reinforcement
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT00270231: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT00270231 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00270231, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Despite preclinical evidence supporting the role of the endogenous opioid system in the reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a tobacco dependence treatment remains unresolved. Research is needed to identify those smokers for whom NTX will have the strongest beneficial effects on smoking behavior. The research bridges existing knowledge of genetic, pharmacologic, and behavioral responses to nicotine, and translates this knowledge to treatment for tobacco dependence. The immediate goal was to test whether genetic variation in the mu-opioid receptor gene predicts the effects of naltrexone (NTX) on nicotine reinforcement.
Primary Outcome
On day 4 of each study medication period, participants completed a cigarette choice procedure where the subject is asked to take 4 puffs from a nicotinized (nicotine-containing) or a denicotinized (no nicotine) cigarette every 30 minutes for 2 hours (maximum of 24 puffs). The outcome variable is the number of nicotine cigarette choices or puffs out of 24 total puffs during these cigarette choice procedures. Subjects who had the A/A genotype took an average of 18.5 puffs from the nicotine-contai
Interventions
- DRUG Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2004-03 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
What the finished NCT00270231 record still lists
NCT00270231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00270231 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00270231 about?
NCT00270231 is a clinical study titled "Effects of Naltrexone on Nicotine Reinforcement". Despite preclinical evidence supporting the role of the endogenous opioid system in the reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a tobacco dependence treatment remains unresolved. Research is needed to identify those smokers for whom NTX will have th...
What is the current status of trial NCT00270231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2004-03. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00270231?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT00270231?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00270231's enrollment target sits among peer trials
64 996th of 2000 higher than 992 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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