Nicotine Replacement Treatment for Pregnant Smokers - 1

NCT00115687 | Terminated Phase 2 DMC

• 3 other identifiers: NIDA-15167-1R01-15167-1DPMCDA
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Tobacco Use Disorder

Keywords

nicotine addiction

Outcome Measures

Primary Outcomes (1)

• Biochemically validated quit rates

  6 weeks after treatment, end of pregnancy

Secondary Outcomes (2)

• tobacco exposure measurements

  6 weeks after treatment, end of pregnancy

• birth weight

  time of delivery

Study Arms (2)

A

PLACEBO COMPARATOR

placebo

Drug: placebo

B

EXPERIMENTAL

2 mg nicotine gum

Drug: 2 mg nicotine polacrilex

Interventions

placebo DRUG

A

2 mg nicotine polacrilex DRUG

B

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (4)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

• 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.

  PMID: 18827129 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Cheryl A Oncken, M.D.

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 23, 2005
• First Posted: June 24, 2005
• Study Start: June 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 12, 2017

Record last verified: 2010-05

Locations

US (4)