Strategies to Avoid Returning to Smoking

NCT00757068 | Completed DMC

• 2 other identifiers: LEVINER01R01DA021608
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking

Keywords

Non-smoking; Women; Pregnancy; Treatment; Mood; Weight; Supportive; Adjustment

Outcome Measures

Primary Outcomes (1)

• Abstinence at 12 months postpartum

  through 12 months

Secondary Outcomes (1)

• Explore factors associated with abstinence postpartum.

  0-12 months

Study Arms (2)

SBT

ACTIVE COMPARATOR

Women assigned to SBT (blue) will receive a six month program that offers to help them stay quit after having a baby.

Behavioral: Supportive Behavioral Therapy

CBT

EXPERIMENTAL

Women assigned to CBT (pink) will receive a six month treatment designed to provide support and address the concerns of women who have just had a baby and do not want to resume smoking.

Behavioral: CBT addressing postpartum mood and weight concerns

Interventions

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.

Also known as: STARTS, Strategies to Avoid Returning to Smoking

CBT

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.

Also known as: Smoking cessation, General

SBT

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Levine MD, Emery RL, Kolko Conlon RP, Marcus MD, Germeroth LJ, Salk RH, Cheng Y. Depressive Symptoms Assessed Near the End of Pregnancy Predict Differential Response to Postpartum Smoking Relapse Prevention Intervention. Ann Behav Med. 2020 Jan 24;54(2):119-124. doi: 10.1093/abm/kaz026.

  PMID: 31219152 DERIVED

• Levine MD, Cheng Y, Marcus MD, Kalarchian MA, Emery RL. Preventing Postpartum Smoking Relapse: A Randomized Clinical Trial. JAMA Intern Med. 2016 Apr;176(4):443-52. doi: 10.1001/jamainternmed.2016.0248.

  PMID: 26998789 DERIVED

MeSH Terms

Conditions

Smoking; Body Weight

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele D Levine, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)