Tobacco Use in Opioid Agonist Treated Pregnant Women

NCT ID: NCT00497068

Last Updated: 2013-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tobacco abstinent contingent voucher

Tobacco abstinent contingent voucher condition

Group Type EXPERIMENTAL

tobacco abstinent contingent

Intervention Type BEHAVIORAL

Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence

non-contingent

Participants receive vouchers non-contingent upon tobacco use status

Group Type EXPERIMENTAL

non-contingent

Intervention Type BEHAVIORAL

Participants receive vouchers regardless of tobacco use status

no voucher

This is the standard care intervention

Group Type OTHER

control

Intervention Type BEHAVIORAL

this group receives no vouchers

Interventions

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tobacco abstinent contingent

Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence

Intervention Type BEHAVIORAL

non-contingent

Participants receive vouchers regardless of tobacco use status

Intervention Type BEHAVIORAL

control

this group receives no vouchers

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Hendree E. Jones

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hendree E Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Tuten M, Svikis DS, Keyser-Marcus L, O'Grady KE, Jones HE. Lessons learned from a randomized trial of fixed and escalating contingency management schedules in opioid-dependent pregnant women. Am J Drug Alcohol Abuse. 2012 Jul;38(4):286-92. doi: 10.3109/00952990.2011.643977. Epub 2012 Feb 22.

Reference Type DERIVED
PMID: 22352784 (View on PubMed)

Other Identifiers

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R01DA012403

Identifier Type: NIH

Identifier Source: secondary_id

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DPMCDA

Identifier Type: -

Identifier Source: secondary_id

R01DA012403

Identifier Type: NIH

Identifier Source: org_study_id

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