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NCT01664741 · ClinicalTrials.gov registry record · Phase 4
Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging
A Phase 4 study of Nicotine Dependence, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT01664741: Completed Phase 4 study of Nicotine Dependence, sponsored by Johns Hopkins University.
NCT01664741 is a Phase 4 study of Nicotine Dependence that has completed, run by Johns Hopkins University. The registered enrollment target is 127 participants, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (31% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01664741, a Phase 4 study of Nicotine Dependence, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed research will provide significant new gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to explain the differences in the prevalence of smoking in men and women, sex-specific differences in nicotine craving and withdrawal as well as the poorer therapeutic response to NRT. This work may pave the way to the design of improved pharmacotherapies that can more effectively target the endogenous opioid system in the treatment of nicotine dependence.
Primary Outcome
BP provides an estimate of the product of the density of available receptors (Bmax' or the receptor density Bmax less those occupied by endogenous transmitters) and the affinity \[1/equilibrium dissociation constant (KD)\]. We use reference tissue graphical analysis (RTGA) to obtain regional BP values using occipital lobe as a reference region. Negative BP change means means a decrease in the BP and positive BP change means an increase in the BP.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Nicotine patch - transdermal
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-12 |
| Phase | Phase 4 |
What the finished NCT01664741 record still lists
NCT01664741 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 185-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01664741 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01664741 about?
NCT01664741 is a clinical study titled "Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging". The proposed research will provide significant new gender-specific information of scientific and clinical relevance on the function of the mu-opioid system in nicotine dependence and therapeutic effectiveness of nicotine replacement therapy (NRT). The studies will help to explain the differences in ...
What is the current status of trial NCT01664741?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2012-04. Estimated completion is 2018-12.
What conditions does trial NCT01664741 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT01664741?
The interventions under investigation include: placebo (DRUG), Nicotine patch - transdermal (DRUG).
Who is sponsoring clinical trial NCT01664741?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01664741 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine Dependence
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 NCT01664741's enrollment target sits among peer trials
127 29th of 67 higher than 39 of 67 other Nicotine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nicotine Dependence 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.
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