Tobacco Use in Opioid Agonist Treated Pregnant Women

Completed · Phase 2/Phase 3

Conditions studied: Nicotine Dependence

In brief

The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.

Key facts

Study ID: NCT00497068
Run by: Johns Hopkins University
People needed: 210
Starts: 2005-01-01
Expected to finish: 2010-06-01
Last updated by the study team: 2013-03-05

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Confirmed pregnancy
Treatment entry at or before 31 weeks EGA
Expected to enter drug-free outpatient modality at CAP
Placed on methadone pharmacotherapy
Nicotine dependent
Sufficient literacy and understanding for assessment procedures
Expected availability for study duration (e.g., complete inpatient stay)
Able and willing to provide informed consent
At least 18 years of age
Confirmed smoker of 10 or more cigarettes

You may not qualify if…

Not pregnant
EGA of 32 weeks or greater
17 years of age or younger
Undergoing detoxification (non-methadone treatment)
Unable to provide informed consent
Currently receiving nicotine replacement products (NRT)
Current diagnosis of alcohol or benzodiazepine dependence
Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.

Where it is running

Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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