SmokingSTARTSNCT00757068
Strategies to Avoid Returning to Smoking
A study testing CBT addressing postpartum mood and weight concerns and Supportive Behavioral Therapy in people with Smoking, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- CBT addressing postpartum mood and weight concerns and Supportive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation
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.
Read the detailed description
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.
- Conditions
- Smoking
- Being tested
- CBT addressing postpartum mood and weight concerns, Supportive Behavioral Therapy
- Keywords
- Non-smoking, Women, Pregnancy, Treatment, Mood, Weight, Supportive, Adjustment
- Medical subject headings
- Smoking, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT addressing postpartum mood and weight concernsBehavioural
Also called STARTS, Strategies to Avoid Returning to Smoking
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.
Supportive Behavioral TherapyBehavioural
Also called Smoking cessation, General
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CBT addressing postpartum mood and weight concerns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence at 12 months postpartum
Measured: through 12 months
Secondary outcomes (1)
Explore factors associated with abstinence postpartum.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michele D Levine, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757068
- Sponsor's protocol ID
- LEVINER01
- Other IDs
- R01DA021608
- Acronym
- STARTS
- Status last verified
- May 2015
- First submitted
- 19 Sep 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31219152Levine 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.
PubMed 26998789
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation
- ClinicalTrials.gov ID
- NCT00757068
- Acronym / sponsor ID
- STARTS / LEVINER01
- Conditions
- Smoking
- Keywords
- Non-smoking, Women, Pregnancy, Treatment, Mood, Weight, Supportive, Adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBT | Active comparator | Behavioral: Supportive Behavioral TherapyWomen assigned to SBT (blue) will receive a six month program that offers to help them stay quit after having a baby. |
| CBT | Experimental | Behavioral: CBT addressing postpartum mood and weight concernsWomen 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Women will be eligible to participate if they:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT addressing postpartum mood and weight concernsAlso: STARTS, Strategies to Avoid Returning to SmokingWomen 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. | Behavioural | CBT |
| Supportive Behavioral TherapyAlso: Smoking cessation, GeneralWomen 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. | Behavioural | SBT |
Primary outcome
Abstinence at 12 months postpartum
Time frame: through 12 months
1 secondary outcome
Explore factors associated with abstinence postpartum.
Time frame: 0-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 31219152Levine 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.
- Derived from this study: PubMed 26998789Levine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele D Levine, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT addressing postpartum mood and weight concerns and Supportive Behavioral Therapy in people with Smoking, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence at 12 months postpartum (time frame: through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.