SmokingPhase 4NCT00224419
Testing Pharmacological Therapies for Pregnant Smokers
A Phase 4 study testing Motivational interviewing for smoking cessation, Cognitive behaviors therapy and CBT + NRT in people with Smoking and Pregnancy, run by Duke University at 2 sites in United States.
Trial summary
Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Motivational interviewing for smoking cessation, Cognitive behaviors therapy and CBT + NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2003to Aug 2006
- Phase
- Phase 4
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Be between 13 and 25 weeks of pregnancy
- Be receiving prenatal care at one of the participating clinics
- Have smoked at least 100 cigarettes in their lifetime
- Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
- Speak and write English
Who cannot join
- Evidence of cognitive or mental health problems
- Evidence of possible drug or alcohol addiction
- Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
- Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Womack Army Medical Center
Fayetteville, North Carolina, 28310
About this study
Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.
Read the detailed description
The proposed five-year study is designed to evaluate the effectiveness of providing over-the-counter (OTC) nicotine replacement therapy, choice of gum, lozenge or patch, (NRT) to promote prepartum smoking cessation. Proposed is a two-arm design. Eligible pregnant women (N=300) will be randomized to either: Arm 1, Tailored Cognitive Behavioral Treatment (TCBT, n=100) that provides women with customized risk information about smoking and nicotine, the potential harms to the fetus and encouragement of appropriate behavioral skills building; or Arm 2, TCBT + NRT - the tailored intervention incorporating NRT information plus choice of patch or gum (n=200). The intervention will include 5 face-to-face contacts as part of prenatal visits and 1 telephone counseling session. Primary outcome measures will be biochemically validated 7-day prevalent abstinence rates at the 19-27th and 29-37th week of pregnancy. Secondary outcomes will include 7-day prevalent abstinence rates at 12 weeks postpartum, serious quit attempts, compliance with NRT, and use of materials. Saliva cotinine will be measured among all women at baseline, the 27-35th week of pregnancy, and 12 weeks postpartum. The significance of this project is that it relies on transdisciplinary collaborations to extend the science in nicotine replacement therapies to a population that could derive substantial health benefits. Moreover, the study results have immediate potential to inform clinical recommendations for integrating nicotine replacement into prenatal care.
- Being tested
- Motivational interviewing for smoking cessation, Cognitive behaviors therapy, CBT + NRT
- Keywords
- Smoking cessation, Pregnancy, Nicotine replacement therapy, Motivational interviewing
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing for smoking cessationBehavioural
Also called Nicoderm CQ (patch), Nicorertte (gum), Commit (lozenge)
All participants received a tailored CBT (TCBT) intervention that included: a written self-help guide, info about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Women in the TCBT + NRT arm were guided through a process of deciding on nicotine gum, lozenge or patch. To minimize fetal exposure, the dose of NRT was customized to the woman's current level of smoking. Women who smoked 5-10 cigarettes a day were given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smoked per day. Those who smoked 11 cigarettes or more per day were given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smoked per day, not to exceed 15 lozenges or pieces of gum per day.
Cognitive behaviors therapyBehavioural
6 counseling sessions delivered over the phone or in person
CBT + NRTDrug
Also called Nicoderm CQ (patch), Nicorette (gum), Commit (lozenge)
Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount
| Study group | Role | What they receive |
|---|---|---|
| 1 - CBT Counseling | Active comparator | Participants in this arm received a tailored CBT (TCBT) intervention that included: a written self-help guide, feedback about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Receives: Behavioral: Motivational interviewing for smoking cessation; Behavioral: Cognitive behaviors therapy |
| 2 - Counseling + NRT | Experimental | Women in this arm received the TCBT described in Arm 1, plus their choice of NRT. To minimize fetal exposure to nicotine for women in the TCBT+NRT arm, the dose of NRT are customized to the woman's current level of smoking. Women who smoke 5-10 cigarettes a day will be given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smokes per day. Those who smoke 11 cigarettes or more per day will be given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smokes per day, not to exceed 15 lozenges or pieces of gum per day. Receives: Behavioral: Motivational interviewing for smoking cessation; Drug: CBT + NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-validated smoking cessation
Measured: middle and late pregnancy
Secondary outcomes (1)
Biochemically-validated smoking cessation
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionAug 2006
Why it stopped: was terminated due to meeting a priori stopping rule set by DSMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Evan Myers, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224419
- Sponsor's protocol ID
- Pro00007724
- Other IDs
- Duke University IRB #2865, CA89053
- Status last verified
- Apr 2009
- First submitted
- 21 Sep 2005
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pletsch PK, Pollak KI, Peterson BL, Park J, Oncken CA, Swamy GK, Lyna P. Olfactory and gustatory sensory changes to tobacco smoke in pregnant smokers. Res Nurs Health. 2008 Feb;31(1):31-41. doi: 10.1002/nur.20229.
PubMed 18161772Pollak KI, Oncken CA, Lipkus IM, Peterson BL, Swamy GK, Pletsch PK, Lyna P, Namenek Brouwer RJ, Fish LJ, Myers ER. Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial. Nicotine Tob Res. 2006 Aug;8(4):547-54. doi: 10.1080/14622200600789882.
PubMed 16920652Bursey-Reddick, K, Swamy, GK, Brouwer, RN, Pollak, KI, Myers, ER. (2006). Comparison of Self-Reported Smoking Status and Anonymous Urinary Cotinine Testing in Pregnancy. American Journal of Obstetrics & Gynecology, 193 Supplement 6:S107.
Pollak KI, Oncken CA, Lipkus IM, Lyna P, Swamy GK, Pletsch PK, Peterson BL, Heine RP, Brouwer RJ, Fish L, Myers ER. Nicotine replacement and behavioral therapy for smoking cessation in pregnancy. Am J Prev Med. 2007 Oct;33(4):297-305. doi: 10.1016/j.amepre.2007.05.006.
PubMed 17888856Swamy GK, Roelands JJ, Peterson BL, Fish LJ, Oncken CA, Pletsch PK, Myers ER, Whitecar PW, Pollak KI. Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial. Am J Obstet Gynecol. 2009 Oct;201(4):354.e1-7. doi: 10.1016/j.ajog.2009.06.006. Epub 2009 Aug 7.
PubMed 19664750
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Pharmacological Therapies for Pregnant Smokers
- ClinicalTrials.gov ID
- NCT00224419
- Acronym / sponsor ID
- Pro00007724
- Keywords
- Smoking cessation, Pregnancy, Nicotine replacement therapy, Motivational interviewing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: was terminated due to meeting a priori stopping rule set by DSMB
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Aug 2006 (actual)
- First posted
- 23 Sep 2005 (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.
Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.
Detailed description
The proposed five-year study is designed to evaluate the effectiveness of providing over-the-counter (OTC) nicotine replacement therapy, choice of gum, lozenge or patch, (NRT) to promote prepartum smoking cessation. Proposed is a two-arm design. Eligible pregnant women (N=300) will be randomized to either: Arm 1, Tailored Cognitive Behavioral Treatment (TCBT, n=100) that provides women with customized risk information about smoking and nicotine, the potential harms to the fetus and encouragement of appropriate behavioral skills building; or Arm 2, TCBT + NRT - the tailored intervention incorporating NRT information plus choice of patch or gum (n=200). The intervention will include 5 face-to-face contacts as part of prenatal visits and 1 telephone counseling session. Primary outcome measures will be biochemically validated 7-day prevalent abstinence rates at the 19-27th and 29-37th week of pregnancy. Secondary outcomes will include 7-day prevalent abstinence rates at 12 weeks postpartum, serious quit attempts, compliance with NRT, and use of materials. Saliva cotinine will be measured among all women at baseline, the 27-35th week of pregnancy, and 12 weeks postpartum. The significance of this project is that it relies on transdisciplinary collaborations to extend the science in nicotine replacement therapies to a population that could derive substantial health benefits. Moreover, the study results have immediate potential to inform clinical recommendations for integrating nicotine replacement into prenatal care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - CBT Counseling | Active comparator | Behavioral: Motivational interviewing for smoking cessation, Behavioral: Cognitive behaviors therapyParticipants in this arm received a tailored CBT (TCBT) intervention that included: a written self-help guide, feedback about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. |
| 2 - Counseling + NRT | Experimental | Behavioral: Motivational interviewing for smoking cessation, Drug: CBT + NRTWomen in this arm received the TCBT described in Arm 1, plus their choice of NRT. To minimize fetal exposure to nicotine for women in the TCBT+NRT arm, the dose of NRT are customized to the woman's current level of smoking. Women who smoke 5-10 cigarettes a day will be given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smokes per day. Those who smoke 11 cigarettes or more per day will be given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smokes per day, not to exceed 15 lozenges or pieces of gum per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age
- Be between 13 and 25 weeks of pregnancy
- Be receiving prenatal care at one of the participating clinics
- Have smoked at least 100 cigarettes in their lifetime
- Be currently smoking and have smoked at least 5 cigarettes per day in the past 7 days
Key exclusion criteria (4 listed)
- Evidence of cognitive or mental health problems
- Evidence of possible drug or alcohol addiction
- Documented history in medical chart of mental retardation, significant chronic or recurrent psychiatric disorder such as schizophrenia or severe depression, history of cardiac arrhythmias, history of myocardial infarction within the past 6 months, history of previous pregnancy with congenital anomaly,family history of congenital anomalies
- Complications of pregnancy during the current pregnancy, including: threatened miscarriage, congenital anomalies, unexplained vaginal bleeding, pelvic or abdominal surgical procedures, deep venous thrombosis, malignancy
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 |
|---|---|---|
| Motivational interviewing for smoking cessationAlso: Nicoderm CQ (patch), Nicorertte (gum), Commit (lozenge)All participants received a tailored CBT (TCBT) intervention that included: a written self-help guide, info about the importance of reducing nicotine exposure to the fetus, 5 face to face and 1 telephone counseling session. Women in the TCBT + NRT arm were guided through a process of deciding on nicotine gum, lozenge or patch. To minimize fetal exposure, the dose of NRT was customized to the woman's current level of smoking. Women who smoked 5-10 cigarettes a day were given the 14 mg patch or instructed to use one 2 mg lozenge or 2 mg piece of gum to replace each cigarette she usually smoked per day. Those who smoked 11 cigarettes or more per day were given the 21 mg patch or instructed to use no more than one lozenge (2 mg) or piece of gum (2 mg) to replace each cigarette she usually smoked per day, not to exceed 15 lozenges or pieces of gum per day. | Behavioural | 1 - CBT Counseling, 2 - Counseling + NRT |
| Cognitive behaviors therapy6 counseling sessions delivered over the phone or in person | Behavioural | 1 - CBT Counseling |
| CBT + NRTAlso: Nicoderm CQ (patch), Nicorette (gum), Commit (lozenge)Includes CBT from arm 1 plus choice of NRT (lozenge, gum, or patch) tailored to smoking amount | Drug | 2 - Counseling + NRT |
Primary outcome
Biochemically-validated smoking cessation
Time frame: middle and late pregnancy
1 secondary outcome
Biochemically-validated smoking cessation
Time frame: 3 months postpartum
Results and safety
The study was stopped early (reason given: was terminated due to meeting a priori stopping rule set by DSMB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Background: PubMed 18161772Pletsch PK, Pollak KI, Peterson BL, Park J, Oncken CA, Swamy GK, Lyna P. Olfactory and gustatory sensory changes to tobacco smoke in pregnant smokers. Res Nurs Health. 2008 Feb;31(1):31-41. doi: 10.1002/nur.20229.
- Background: PubMed 16920652Pollak KI, Oncken CA, Lipkus IM, Peterson BL, Swamy GK, Pletsch PK, Lyna P, Namenek Brouwer RJ, Fish LJ, Myers ER. Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial. Nicotine Tob Res. 2006 Aug;8(4):547-54. doi: 10.1080/14622200600789882.
- BackgroundBursey-Reddick, K, Swamy, GK, Brouwer, RN, Pollak, KI, Myers, ER. (2006). Comparison of Self-Reported Smoking Status and Anonymous Urinary Cotinine Testing in Pregnancy. American Journal of Obstetrics & Gynecology, 193 Supplement 6:S107.
- Results publication: PubMed 17888856Pollak KI, Oncken CA, Lipkus IM, Lyna P, Swamy GK, Pletsch PK, Peterson BL, Heine RP, Brouwer RJ, Fish L, Myers ER. Nicotine replacement and behavioral therapy for smoking cessation in pregnancy. Am J Prev Med. 2007 Oct;33(4):297-305. doi: 10.1016/j.amepre.2007.05.006.
- Derived from this study: PubMed 19664750Swamy GK, Roelands JJ, Peterson BL, Fish LJ, Oncken CA, Pletsch PK, Myers ER, Whitecar PW, Pollak KI. Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial. Am J Obstet Gynecol. 2009 Oct;201(4):354.e1-7. doi: 10.1016/j.ajog.2009.06.006. Epub 2009 Aug 7.
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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.
Evan Myers, MD, MPH principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivational interviewing for smoking cessation, Cognitive behaviors therapy and CBT + NRT in people with Smoking and Pregnancy, run by Duke University at 2 sites 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: was terminated due to meeting a priori stopping rule set by DSMB). Results are not available in the source record.
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?
Biochemically-validated smoking cessation (time frame: middle and late pregnancy). 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 NCT00224419, which also lists 5 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 21 Jul 2014.