Progesterone and Brain Imaging Study | NCT01954966

NCT01954966

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
K24DA030301	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Progesterone 200 mg capsules	Active Comparator	Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days.	Drug: Progesterone
Progesterone 200 mg look-alike capsules	Placebo Comparator	Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])	GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex [DACC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.	Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])	GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex [DLPFC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.	Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.

Secondary Outcomes

Measure	Description	Time Frame
Symptoms During Nicotine Abstinence (NWSC)	Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal).	Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)

Eligibility Module

Name	Affiliation	Role
Cynthia N Epperson, M.D.	Associate Professor of Psychiatry, University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Penn Center for Women's Behavioral Wellness		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15607299	Background	Epperson CN, O'Malley S, Czarkowski KA, Gueorguieva R, Jatlow P, Sanacora G, Rothman DL, Krystal JH, Mason GF. Sex, GABA, and nicotine: the impact of smoking on cortical GABA levels across the menstrual cycle as measured with proton magnetic resonance spectroscopy. Biol Psychiatry. 2005 Jan 1;57(1):44-8. doi: 10.1016/j.biopsych.2004.09.021.
22871916	Background	Cai K, Nanga RP, Lamprou L, Schinstine C, Elliott M, Hariharan H, Reddy R, Epperson CN. The impact of gabapentin administration on brain GABA and glutamate concentrations: a 7T (1)H-MRS study. Neuropsychopharmacology. 2012 Dec;37(13):2764-71. doi: 10.1038/npp.2012.142. Epub 2012 Aug 8.

Label	URL
Center Website	View source

ID	Title	Description
FG000	Placebo First, Progesterone Second	This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial.
FG001	Progesterone First, Placebo Second	This group was randomized to receive progesterone during phase 1 of the crossover trial and placebo during phase 2 of the crossover trial.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo First, Progesterone Second	This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial.
BG001	Progesterone First, Placebo Second

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		N = 1 participant was missing age information in the progesterone first, placebo second randomization group.

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])	GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex [DACC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.	Some values were missing due to visits for these individuals scheduled after there were issues with the 7T scanner, so data could not be collected for other participants.	Posted		Mean	Standard Error	mg/dl		Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Progesterone 200 mg Look-alike Capsules	This arm includes all phases when participants were received placebo (phase 1/week 1 for participants randomized to receive placebo first; phase 2/week 2 for participants randomized to receive placebo second)

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	Nervous system disorders		Systematic Assessment

Title	Organization	Phone	Extension	Email
Claudia Iannelli	University of Pennsylvania	6104424426		Claudia.iannelli@pennmedicine.upenn.edu

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 1, 2017	Apr 26, 2022	Prot_SAP_000.pdf

ID	Term
D014029	Tobacco Use Disorder
D012907	Smoking

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior

ID	Term
D011374	Progesterone

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

ID	Title	Description
OG000	Progesterone 200 mg Capsules	Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: 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.
OG001	Progesterone 200 mg Look-alike Capsules	Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: 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.