Terminé

Phase 2 Study of the Efficacy of Voucher-Based Incentives to Treat Pregnant Smokers

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Voucher-based incentives

+ Voucher-based incentives

+ Voucher-based incentives

Comportemental
Qui peut participer

De 18 à 45 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Groupe Placebo
Interventionnel
Date de début : avril 2006
Voir le détail du protocole

Résumé

Sponsor principalUniversity of Vermont
Dernière mise à jour : 12 mai 2023
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 avril 2006

Date à laquelle le premier participant a commencé l'étude.

Maternal cigarette smoking is the leading preventable cause of poor pregnancy outcomes and pediatric morbidity and mortality in the U.S. Efficacious interventions have been developed for smoking cessation during pregnancy, but cessation rates are low, typically under 20%. Efficacious interventions to prevent postpartum relapse remain to be developed. This application seeks support for a Stage II behavioral therapies development project to continue examining interventions to increase smoking cessation above the low levels noted above and to decrease postpartum relapse. With regard to cessation, we conducted studies during the prior funding period showing that voucher-based incentives delivered contingent on biochemically-verified abstinence promote smoking cessation in approximately 40% of women who were still smoking at their 1st prenatal visit compared to only 9% in a control condition. Comparable studies on decreasing postpartum relapse among women who were smokers upon learning of their pregnancy but quit by their 1st prenatal visit (spontaneous quitters) supported the efficacy of abstinence-contingent vouchers for preventing antepartum but not postpartum relapse. We also completed secondary studies on appropriate cutpoints for biochemically verifying smoking status in pregnant women, characterizing the quantitative relationship between smoking exposure and fetal growth, the time-course of depressive symptoms during pregnancy in smokers and abstainers, and the incidence and severity of nicotine withdrawal. While the treatment effect on smoking cessation during pregnancy noted above is at least two-fold greater than usual outcomes, the majority of women, especially heavier smokers (> 10 cigs/day), failed to quit. In Study 1 of this application we propose to experimentally examine whether a revised voucher program designed to increase initial abstinence and encourage additional quit attempts among those who initially fail can promote cessation at the end-of-pregnancy assessment in the majority of women treated (> 60%). Considering that nobody has succeeded in decreasing postpartum relapse among spontaneous quitters, we are not surprised that our first effort was unsuccessful. In Study 2 of this application we propose to experimentally test whether a revised voucher-based incentive program designed to more effectively reinforce sustained abstinence will decrease postpartum relapse. We are also proposing to continue secondary studies on biochemical verification of smoking status, fetal growth, and predictors of postpartum relapse. Overall, the proposed studies have the potential to contribute important new information on effective treatments for one of our nation's most daunting drug abuse problems.

Sponsor principalUniversity of Vermont
Dernière mise à jour : 12 mai 2023
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

166 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères

Femme

Le sexe biologique des participants éligibles à s'inscrire.

De 18 à 45 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Critères

Inclusion Criteria: Only women will participate in the proposed study, because the overarching aim is to develop efficacious treatments for smoking cessation and relapse prevention during pregnancy and early postpartum. All participants will be currently pregnant and report being smokers at the time of conception. Those in Study 1 will report continuing to smoke upon entering prenatal care. Those in Study 2 will report having already quit smoking upon entering prenatal care. Women must reside in the county in which the clinic is located, plan to reside in this geographical area through 6 months postpartum, be < 25 weeks gestation, not be living in a group residence, English speaking, and not regularly receiving psychotropics other than antidepressants. - Exclusion Criteria: Women receiving opioid substitution therapy will be excluded. In Vermont, minorities comprise 4% of the general population. There will be no exclusion criteria concerning race or ethnicity. In our studies during the prior funding period, approximately 5% of participants were minorities. We anticipate a similar sample in the proposed studies. We shall do all that we can to assure that minorities are included in the research. -

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

3 groupes d'intervention sont désignés dans cette étude

33,333% de chances d'être dans le groupe placebo en aveugle

Groupes de traitement

Groupe I

Expérimental
Women will receive an abstinence-contingent voucher-based incentives intervention (Contingency Management) for smoking cessation and relapse prevention.

Groupe II

Expérimental
Women receive abstinence-contingent voucher-based incentives (Contingency Management) intervention designed to further increase cessation and relapse prevention rates.

Groupe III

Dispositif fictif
This serves as a control condition wherein women earn incentives independent of smoking status.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Substance Abuse Treatment Center, University of Vermont; UHC

Burlington, United StatesOuvrir Substance Abuse Treatment Center, University of Vermont; UHC dans Google Maps
Terminé1 Centres d'Étude