NCT00497068

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

4.7 years

First QC Date

July 5, 2007

Last Update Submit

March 1, 2013

Conditions

Nicotine Dependence

Keywords

smokingpregnancyneonatal abstinence syndrome

Outcome Measures

Primary Outcomes (1)

  • Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score

    from treatment entry until 6 weeks post-partum

Secondary Outcomes (1)

  • tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters

    from treatment entry to 6 weeks posrt-partum

Study Arms (3)

tobacco abstinent contingent voucher

EXPERIMENTAL

Tobacco abstinent contingent voucher condition

Behavioral: tobacco abstinent contingent

non-contingent

EXPERIMENTAL

Participants receive vouchers non-contingent upon tobacco use status

Behavioral: non-contingent

no voucher

OTHER

This is the standard care intervention

Behavioral: control

Interventions

tobacco abstinent contingentBEHAVIORAL

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

tobacco abstinent contingent voucher
non-contingentBEHAVIORAL

Participants receive vouchers regardless of tobacco use status

non-contingent
controlBEHAVIORAL

this group receives no vouchers

no voucher

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

    PMID: 22352784DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmokingNeonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hendree E Jones, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

January 1, 2005

Primary Completion

September 1, 2009

Study Completion

June 1, 2010

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(1)