Tobacco Use DisorderPhase 2NCT00115687
Nicotine Replacement Treatment for Pregnant Smokers - 1
A Phase 2 study testing 2 mg nicotine polacrilex in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 4 sites in United States.
Trial summary
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- 2 mg nicotine polacrilex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2002to Apr 2007
- Phase
- Phase 2
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient's gestational age is 26 weeks or less.
- Patient is at least 16 years of age.
- Patient is able to speak English or Spanish.
- Patient intends to carry to term.
- Patient has stable residence.
- Patient has smoked five or more cigarettes everyday for the past seven days.
Who cannot join
- Evidence that the patient is pregnant with a fetus with a known congenital abnormality.
- Unstable medical problems (i.e., hyperthyroidism, temporomandibular joint disorder, pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- Multiple Gestation
- Unstable psychiatric disorder
- Current drug or alcohol abuse or dependence
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Connecticut Health Center
Farmington, Connecticut, 06030
Hartford Hospital
Hartford, Connecticut, 06106
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Nicotine Replacement Treatment for Pregnant Smokers
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.
The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.
Read the detailed description
This proposal will examine the utility of one first-line medication, nicotine gum, as an aid to smoking cessation during pregnancy.
The specific aims are:
- (1) To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive nicotine gum (2 mg dose) or a matching placebo;
- (2) To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety (i.e., overall nicotine and tobacco exposure at 6 weeks after the quit date and at 32-34 weeks gestation) and birth weight at the time of delivery;
- (3) To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy.
Subjects will be recruited from prenatal clinics that serve primarily a low-income, minority population. Two hundred sixty-eight pregnant smokers will be randomly assigned to receive smoking cessation behavioral counseling and either a 6-week course of mint flavored placebo or nicotine gum, followed by 6 weeks of decreasing doses. Maternal blood for genotyping will be obtained at study entry. Primary outcome measures will be 7-day point prevalence of cigarette abstinence, number of cigarettes smoked per day, urinary cotinine concentrations, and measures of tobacco exposure (i.e., carbon monoxide in exhaled air and urine anabasine and anatabine) at 6 weeks after the quit date and at 32-34 weeks gestation, and infant birth weight. We hypothesize that:
- (1) Pregnant smokers who are randomized to nicotine gum will have double the quit rates and will reduce their smoking to a greater degree than subjects randomized to placebo;
- (2) Nicotine gum compared to placebo will reduce maternal levels of tobacco-exposure markers and increase birth weights in the offspring;
- (3) The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day.
- Conditions
- Tobacco Use Disorder
- Being tested
- placebo, 2 mg nicotine polacrilex
- Keywords
- nicotine addiction
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
2 mg nicotine polacrilexDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | placebo Receives: Drug: placebo |
| B | Experimental | 2 mg nicotine gum Receives: Drug: 2 mg nicotine polacrilex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated quit rates
Measured: 6 weeks after treatment, end of pregnancy
Secondary outcomes (2)
tobacco exposure measurements
Measured: 6 weeks after treatment, end of pregnancy
birth weight
Measured: time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study startJun 2002
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Efficacy rates did not show large enough differences between treatments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cheryl A Oncken, M.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115687
- Sponsor's protocol ID
- NIDA-15167-1
- Other IDs
- R01-15167-1, DPMCDA
- Status last verified
- May 2010
- First submitted
- 23 Jun 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oncken C, Dornelas E, Greene J, Sankey H, Glasmann A, Feinn R, Kranzler HR. Nicotine gum for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):859-67. doi: 10.1097/AOG.0b013e318187e1ec.
PubMed 18827129
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Replacement Treatment for Pregnant Smokers
- ClinicalTrials.gov ID
- NCT00115687
- Acronym / sponsor ID
- NIDA-15167-1
- Conditions
- Tobacco Use Disorder
- Keywords
- nicotine addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy rates did not show large enough differences between treatments
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 24 Jun 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.
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers.
The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.
Detailed description
This proposal will examine the utility of one first-line medication, nicotine gum, as an aid to smoking cessation during pregnancy.
The specific aims are:
- (1) To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive nicotine gum (2 mg dose) or a matching placebo;
- (2) To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety (i.e., overall nicotine and tobacco exposure at 6 weeks after the quit date and at 32-34 weeks gestation) and birth weight at the time of delivery;
- (3) To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy.
Subjects will be recruited from prenatal clinics that serve primarily a low-income, minority population. Two hundred sixty-eight pregnant smokers will be randomly assigned to receive smoking cessation behavioral counseling and either a 6-week course of mint flavored placebo or nicotine gum, followed by 6 weeks of decreasing doses. Maternal blood for genotyping will be obtained at study entry. Primary outcome measures will be 7-day point prevalence of cigarette abstinence, number of cigarettes smoked per day, urinary cotinine concentrations, and measures of tobacco exposure (i.e., carbon monoxide in exhaled air and urine anabasine and anatabine) at 6 weeks after the quit date and at 32-34 weeks gestation, and infant birth weight. We hypothesize that:
- (1) Pregnant smokers who are randomized to nicotine gum will have double the quit rates and will reduce their smoking to a greater degree than subjects randomized to placebo;
- (2) Nicotine gum compared to placebo will reduce maternal levels of tobacco-exposure markers and increase birth weights in the offspring;
- (3) The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: placeboplacebo |
| B | Experimental | Drug: 2 mg nicotine polacrilex2 mg nicotine gum |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patient's gestational age is 26 weeks or less.
- Patient is at least 16 years of age.
- Patient is able to speak English or Spanish.
- Patient intends to carry to term.
- Patient has stable residence.
Key exclusion criteria (5 listed)
- Evidence that the patient is pregnant with a fetus with a known congenital abnormality.
- Unstable medical problems (i.e., hyperthyroidism, temporomandibular joint disorder, pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- Multiple Gestation
- Unstable psychiatric disorder
- Current drug or alcohol abuse or dependence
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 |
|---|---|---|
| placebo | Drug | A |
| 2 mg nicotine polacrilex | Drug | B |
Primary outcome
Biochemically validated quit rates
Time frame: 6 weeks after treatment, end of pregnancy
2 secondary outcomes
tobacco exposure measurements
Time frame: 6 weeks after treatment, end of pregnancy
birth weight
Time frame: time of delivery
Results and safety
The study was stopped early (reason given: Efficacy rates did not show large enough differences between treatments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Results publication: PubMed 18827129Oncken C, Dornelas E, Greene J, Sankey H, Glasmann A, Feinn R, Kranzler HR. Nicotine gum for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2008 Oct;112(4):859-67. doi: 10.1097/AOG.0b013e318187e1ec.
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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.
Cheryl A Oncken, M.D. principal investigator
UConn Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2 mg nicotine polacrilex in people with Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 4 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 5 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Efficacy rates did not show large enough differences between treatments). 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 quit rates (time frame: 6 weeks after treatment, end of 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 NCT00115687, which also lists 1 linked publication.
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 12 Jan 2017.