Progesterone for Postpartum Smoking Relapse

Recruiting at 1 trial location

Overseen By Katherine Harrison, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must not be taking: Nicotine replacement, Smoking cessation

Disqualifiers: Depression, Drug use, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

279 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether progesterone (a hormone therapy) can help new mothers remain smoke-free after childbirth and improve their baby's health. Participants will either receive progesterone or not, to compare its effects. Suitable candidates include women who had an uncomplicated pregnancy at 30 weeks or more, or who gave birth in the last 6 months, and who smoked at least four cigarettes a month before pregnancy. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how progesterone can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you do not use nicotine replacement therapy or smoking cessation medications, except for e-cigarettes. Also, you cannot participate if you are taking drugs that may interfere with progesterone treatment.

What is the safety track record for these treatments?

Research has shown that people usually tolerate progesterone well. In one study, women taking progesterone had a 45% success rate in staying smoke-free for eight weeks, compared to 32% in a placebo group. This suggests that progesterone might effectively and safely help people quit smoking.

However, some side effects can occur. The Mayo Clinic notes that progesterone can increase the risk of heart disease or stroke, especially for smokers and those with conditions like diabetes. Discussing potential risks and benefits with a healthcare provider is important before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using progesterone to prevent postpartum smoking relapse because it offers a novel approach compared to standard treatments like nicotine replacement therapies, behavioral counseling, or prescription medications such as bupropion and varenicline. Progesterone, a hormone naturally present in the body, may help reduce cravings and withdrawal symptoms by stabilizing mood and potentially altering the brain's response to nicotine. This hormone-based treatment could be particularly beneficial for new mothers who are looking for non-nicotine-based options to maintain smoking cessation after childbirth. Furthermore, if proven effective, progesterone could add a valuable tool to the limited arsenal currently available for addressing postpartum smoking relapse.

What evidence suggests that this trial's treatments could be effective for preventing postpartum smoking relapse?

Research has shown that progesterone might help prevent new mothers from resuming smoking after childbirth. In this trial, participants in Group 1 will receive progesterone, while those in Group 2 will not. One study found that 45% of women who took progesterone remained smoke-free for at least a week by the eighth week, compared to 32% who took a placebo (a pill with no active medicine). These results suggest that progesterone could effectively help new mothers avoid smoking again. Additionally, women in the study found progesterone acceptable and continued with the treatment, indicating its promise for helping mothers quit smoking after having a baby. ^{1 2 3 4 6}

Who Is on the Research Team?

Sharon Allen, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for women in stable health who are 30-35 weeks pregnant, have quit smoking for at least 4 weeks, and are motivated to stay smoke-free postpartum. They must not be planning pregnancy soon after delivery, using illicit drugs or alcohol excessively, or have certain medical conditions like heart disease or a history of blood clots.

Inclusion Criteria

established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider

I agree to use non-hormonal birth control after giving birth until 12 weeks later.

I am 30-35 weeks pregnant and both my mental and physical health are stable.

Exclusion Criteria

any condition that, in the opinion of the clinical team, precludes participation in the trial.

You have received treatment for drug or alcohol addiction within the last three months.

I am not using aminoglutethimide or planning to get pregnant soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants living in Minnesota will receive a 12-week course of exogenous progesterone

12 weeks

Remote visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including self-administered surveys and self-collection of dried blood spots

6 months

Remote visits

What Are the Treatments Tested in This Trial?

Interventions

• Depot-Medroxyprogestereone Acetate
• Placebo Injection
• Placebo Oral Tablet
• Progesterone 200 MG Oral Capsule

Trial Overview

The study tests if Progesterone (a hormone capsule) can help new moms avoid starting smoking again after giving birth compared to a placebo (a dummy pill). It also looks at how this might benefit the baby's health and explores if there are differences in outcomes based on race and ethnicity.

How Is the Trial Designed?

Group I: Group 2 Active Control 1 Intervention

Participants in this group will not receive progesterone

Group II: Group 1 Active Control 1 Intervention

Participants in this group will receive progesterone

Depot-Medroxyprogestereone Acetate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Depo-Provera for:

• Contraception
• Endometriosis
• Renal carcinoma
• Cervical carcinoma
• Adenocarcinoma of the breast

Approved in European Union as Depo-Provera for:

• Contraception
• Endometriosis
• Renal carcinoma
• Cervical carcinoma
• Adenocarcinoma of the breast

Approved in Canada as Depo-Provera for:

• Contraception
• Endometriosis
• Renal carcinoma
• Cervical carcinoma
• Adenocarcinoma of the breast

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A pooled analysis of two case-control studies involving 1,768 women with breast cancer and 13,905 controls found that the overall relative risk (RR) of breast cancer for women who had ever used depot medroxyprogesterone acetate (DMPA) was 1.1, indicating no significant increase in risk.

However, recent or current users of DMPA (within the last 5 years) had a higher estimated RR of 2.0, suggesting that the increased risk may be related to enhanced detection of tumors or accelerated growth of existing tumors, while women who used DMPA more than 5 years ago showed no increased risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depot medroxyprogesterone acetate and breast cancer. A pooled analysis of the World Health Organization and New Zealand studies. Skegg, DC., Noonan, EA., Paul, C., et al.[2022]

Among low-income new mothers in upstate New York, 31.3% received postpartum DMPA, with 62.6% of those receiving it before hospital discharge, highlighting the importance of timely administration to prevent unintended pregnancies.

The study found significant variability in DMPA administration patterns across different hospitals, suggesting a need for further research to improve access and ensure appropriate candidates receive this contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of postpartum depot medroxyprogesterone administration among low-income mothers. Dozier, AM., Nelson, A., Brownell, EA., et al.[2022]

In a study of 1864 New Zealand women aged 25 to 54, 13.7% reported using depot medroxyprogesterone acetate (DMPA) as a contraceptive, with higher usage among Maori women and those with lower income and education levels.

While DMPA has a low contraceptive failure rate of 0.9 per 100 woman-years, many users discontinue due to side effects like menstrual disturbances and weight gain, indicating that its acceptability is limited despite its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depot medroxyprogesterone acetate. Patterns of use and reasons for discontinuation. Paul, C., Skegg, DC., Williams, S.[2019]

In a study of 5,073 women, the use of postpartum depot medroxyprogesterone acetate (DMPA) was not linked to an increase in postpartum depressive symptoms, as indicated by the Patient Health Questionnaire 9 (PHQ-9) screening results.

Despite previous concerns about DMPA potentially causing depression, this research suggests that its use in the immediate postpartum period is safe and should not deter women from using it as a contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between Immediate Postpartum Depot Medroxyprogesterone Acetate Use and Postpartum Depressive Symptoms. Ross, CM., Shim, JY., Stark, EL., et al.[2023]

A study of 404 postpartum women found that administering depot medroxyprogesterone acetate (DMPA) immediately after delivery does not significantly affect the development of postpartum depression (PPD), as indicated by similar Edinburgh Postnatal Depression Scale (EPDS) scores between those who received DMPA and those who did not.

The rates of PPD diagnosis were also comparable, with 10.9% of women receiving DMPA diagnosed with PPD versus 14.1% in the non-DMPA group, suggesting that DMPA does not increase the risk of developing PPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of depot medroxyprogesterone acetate on postpartum depression. Tsai, R., Schaffir, J.[2015]

Depot medroxyprogesterone acetate (DMPA) is a highly effective contraceptive method, with no pregnancies reported within three months of injection among 363 women treated over 20 years, and a high acceptability rate with an average of 6.3 injections per subject.

While some women experienced menstrual disturbances, only 7.3% discontinued due to these issues, and the median delay in return to fertility for those wishing to conceive was 9.2 months, indicating that DMPA is generally safe and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depo-Provera use in an Australian metropolitan practice. Fraser, IS., Dennerstein, GJ.[2015]

In a study of 86 female adolescents using depot medroxyprogesterone acetate (DMPA) for contraception, factors such as race, gynecologic age, and baseline weight were not significantly associated with weight gain during the first 10 to 14 weeks after starting the treatment.

Despite concerns about weight gain linked to DMPA, this study found no significant differences in weight change based on the evaluated characteristics, suggesting that individualized counseling may not need to focus on these specific factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective review of the relationship between weight change and demographic factors following initial depot medroxyprogesterone acetate injection in adolescents. Gerlach, LS., Saldaña, SN., Wang, Y., et al.[2013]

The study involving 183 mothers assessed the impact of immediate postpartum depot medroxyprogesterone (DMPA) on breastfeeding duration, suggesting a potential negative effect, although it was not statistically significant (p=0.24).

After adjusting for confounding factors, the hazard ratio indicated a 22% higher risk of breastfeeding cessation associated with DMPA use, but the evidence remains inconclusive, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of immediate postpartum depot medroxyprogesterone on early breastfeeding cessation. Brownell, EA., Fernandez, ID., Fisher, SG., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5659923/

Progesterone for Smoking Relapse Prevention Following ...

The 7-day point prevalence of abstinence at week 8 was achieved by 45% (n = 10) of women in the progesterone group and 32% (n = 6) of women in the placebo group ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865424001364

A protocol for modifying progesterone to increase ...

This paper outlines the protocol used in our study to evaluate the efficacy of modifying progesterone to increase postpartum smoking abstinence.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5055745/

Progesterone and Postpartum Smoking Relapse: A Pilot ...

We observed high retention and moderate adherence rates, as well as high acceptability among participants.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04783857

Modifying Progesterone and Estradiol Levels to Prevent ...

The investigators aim to address the following specific aims: Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking ...

5.

ctv.veeva.com

ctv.veeva.com/study/modifying-progesterone-and-estradiol-levels-to-prevent-postpartum-cigarette-smoking-relapse-and-redu

Modifying Progesterone and Estradiol Levels to Prevent ...

Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors. Examine the effects of this ...

6.

mayoclinic.org

mayoclinic.org/drugs-supplements/progesterone-oral-route/description/drg-20075298

Progesterone (oral route) - Side effects & dosage

Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high ...