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Completed

NCT Number: NCT00757068

Strategies to Avoid Returning to Smoking

The purpose of this study is to evaluate the relative efficacy of a postpartum smoking relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women who remain abstinent through 12 months postpartum. We hypothesize that women randomized to STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

The goal of the proposed investigation is to determine whether a cognitive behavioral relapse prevention intervention designed to address mood and weight concerns during the postpartum period will decrease the rate of postpartum relapse to smoking. We propose a two-group, randomized controlled trial. Women who quit smoking as a result of pregnancy, have been quit for at least one month prior to delivery and are motivated to remain abstinent postpartum will complete baseline assessments and be randomly assigned during the third trimester of pregnancy to either a cognitive behavioral relapse prevention intervention specifically designed for women who quit smoking during pregnancy, Strategies to Avoid Returning To Smoking (STARTS), or a nonspecific, supportive condition (SUPPORT). Both conditions will receive written information on the dangers of postpartum smoking and an equivalent number and amount of sessions immediately prior to delivery and during the first six months postpartum. Women will be treated for the first six months postpartum because substantial evidence has shown the risk of relapse to be greatest during the six months immediately following delivery (McBride et al., 1990; Mullen et al., 1990). All women will complete assessments at baseline (during pregnancy) and 3, 6 and 12 months postpartum.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women will be eligible to participate if they:
  • report having smoked daily for at least one month during the 3 months prior to becoming pregnant;
  • smoked at least 10 cigarettes per day before quitting;
  • report no smoking in the four weeks prior to enrollment;
  • are not currently smoking as verified by a CO less than 8ppm;
  • are at least 'somewhat' motivated to remain abstinent postpartum and
  • are at least 14 years of age.

Exclusion criteria

  • Women with current, acute psychiatric disorders, including other substance use problems and symptoms that warrant immediate treatment will be referred for care and excluded from this trial.
  • Women with psychiatric disorders (e.g., depressive or anxiety disorders), who are not acutely suicidal and in whom the symptoms are not severe enough to preclude participation in a randomized trial, will be eligible to participate. However, women taking psychiatric medications that may affect the mediators of treatment, such as antidepressant, anxiolytic or weight control medications, will be excluded from participation.
  • Women who endorse current suicidality will be discussed immediately with the consulting physician and referred to the psychiatric emergency room for further evaluation as indicated.

Treatment and study plan

CBT addressing postpartum mood and weight concerns

Behavioral

Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. In these treatment sessions, the counselor will address postpartum mood and weight concerns.

Other names: STARTS, Strategies to Avoid Returning to Smoking

Supportive Behavioral Therapy

Behavioral

Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. A non-specific, supportive condition will be delivered to women who want to remain smoke-free after they give birth.

Other names: Smoking cessation, General

Primary outcomes

  1. Abstinence at 12 months postpartum

    Time frame: through 12 months

Secondary outcomes

  1. Explore factors associated with abstinence postpartum.

    Time frame: 0-12 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation

Acronym: STARTS

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2008
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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