CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Not stated in 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/NCT01954966
NCT01954966Phase 4Completed

Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction

University of Pennsylvania·interventional·Posted Oct 7, 2013·Updated Jul 5, 2022

In Brief

A Phase 4 clinical trial evaluating Progesterone and Placebo for Nicotine Dependence and Nicotine Withdrawal. Completed, enrolled 81 participants across 1 site.

Detailed Summary

Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2013
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 12.7 years ago

Interventions

Progesteronedrug

Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.

Placebodrug

Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.