CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Nicotine patch - transdermal +1 moredrug
Likely dose
Nicotine patch - transdermal 21 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01664741
NCT01664741Phase 4Completed
CompareCT.gov

Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

Johns Hopkins University·interventional·Posted Aug 14, 2012·Updated May 9, 2019

In Brief

A Phase 4 clinical trial evaluating Nicotine patch - transdermal and placebo for Nicotine Dependence. Completed, enrolled 127 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 14, 2012
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 13.9 years ago

Interventions

Nicotine patch - transdermaldrug

21 mg patch

placebodrug