Progesterone & Postpartum Relapse to Smoking

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Progesterone for Postpartum Cocaine Relapse

NCT01249274

Cocaine Abuse Cocaine Dependence

COMPLETED NA

A Mood Management Intervention for Pregnant Smokers

NCT00505869

Pregnancy Smoking

COMPLETED

A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers

NCT05044546

Depression Tobacco Use Disorder

ACTIVE_NOT_RECRUITING NA

Strategies to Avoid Returning to Smoking

NCT00757068

Smoking

COMPLETED NA

PRevention Of Methamphetamine Use Among Postpartum Women Trial (PROMPT)

NCT05128071

Methamphetamine-dependence Postpartum Abstinence

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Cessation Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progesterone

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Placebo

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Progesterone

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Intervention Type DRUG

Placebo

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prometrium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Woman
* 18-35 years old
* Zero CPD for past 4 weeks
* 5 or more CPD for at least 6 out of past 12 months
* Motivated to remain abstinent (7 or higher out of 10)
* Stable physical/mental health
* Established prenatal care
* Stable physical/mental health
* Willing to take Progesterone
* Willing to use double-barrier protection if sexually active
* English fluency
* Able to provide informed consent

Exclusion Criteria

* Psychotropic medications
* Illicit drugs
* Other types of tobacco, NRT, smoking cessation medications
* Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of \>2 miscarriages)
* Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors
* History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes