Progesterone and Brain Imaging Study

Nicotine Dependence Clinical Trial

Official title: Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction

Status Completed

Clinical Trial 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.

Clinical Trial Description

The purpose of this study is to learn whether a sex hormone called progesterone is helpful in reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging to measure possible effects of progesterone on certain neurochemicals. These neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and progesterone affect these brain chemicals.

Individuals wishing to participate in this study must be medically healthy men or women who smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental illness or use drugs other than nicotine and marijuana. Participants cannot have any implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have peanut allergies and must never have had a reaction to progesterone. Finally, participants cannot be taking any medications for anxiety, depression or insomnia. ;

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Withdrawal
• Tobacco Use Disorder

• NCT number: NCT01954966
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Completion date: December 2021