Progesterone for Smoking Relapse Prevention Following Delivery
Progesterone for Postpartum Smokers: Feasibility, Breastfeeding and Infant Safety
Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop.
Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone decreases both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women.
We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06510
- Yale School of Medicine Dpt of Psychiatry
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Need to be within 3 weeks of delivery because relapse to smoking happens early after childbirth
- Aged 18 to 42 years
- history of smoking, with smoking and other nicotine product abstinence achieved in the final two months of pregnancy and at delivery
- In good health as verified by medical history
- Using acceptable birth control methods other than hormonal contraceptives that contain progestins
- Have biologically confirmed abstinence from tobacco and other nicotine products at randomization
Exclusion Criteria:
- A history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, liver failure, or other medical conditions that the physician investigator deems will make study participation unsafe for the subject
- Current or past history bipolar disorder or schizophrenia or current diagnosis of major depression, panic disorder or post-traumatic stress disorder
- Dependence on and/or abuse of alcohol or other drugs of abuse in the month prior to randomization into the trial
- the presence of suicidal or homicidal ideation, or significant impairment of social or occupational functioning, either at study baseline during the evaluation process, or during participation in the trial
- inability to speak Spanish or English (our group is bilingual)
- plans to move out of the area within 8 months after study screening since this will make follow-up difficult
- Inability to understand study procedures or provide informed consent
- Currently undergoing treatment with another pharmacological agent for smoking cessation
- pending legal case that may result in incarceration since this would force abstinence and impede follow-up;
- Pending case with child protective services that might lead removal of infant from mother's custody, as this would impede breastfeeding and infant follow-up
- Unwilling to accept randomization
- Subsequent pregnancy since that would be another source of progesterone
- An acute general medical condition that would require imminent re-hospitalization since this would enforce abstinence (women may be randomized if they are discharged and still within the recruitment window)
- Allergy to progesterone or peanuts (vehicle for micronized progesterone)
- Currently undergoing treatment with ketoconazole or any other known strong CYP3A4 inhibitors
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: placebo
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
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Expérimental: Progesterone
In this group women will receive oral micronized progesterone twice a day.
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oral micronized progesterone
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment
Délai: 8 weeks
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Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken
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8 weeks
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Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention
Délai: From randomization to 3-month follow-up: up to 5 months
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Feasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up
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From randomization to 3-month follow-up: up to 5 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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7-day Point Prevalence of Abstinence at End of Treatment (Week 8)
Délai: Week 8 of the trial period
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Abstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine <100 ng/ml).
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Week 8 of the trial period
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Ariadna Forray, MD, Yale School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1305012130
- R21DA035924 (Subvention/contrat des NIH des États-Unis)
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