search
Back to results

Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tobacco abstinent contingent
non-contingent
control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring smoking, pregnancy, neonatal abstinence syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

tobacco abstinent contingent voucher

non-contingent

no voucher

Arm Description

Tobacco abstinent contingent voucher condition

Participants receive vouchers non-contingent upon tobacco use status

This is the standard care intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2007
Last Updated
March 1, 2013
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00497068
Brief Title
Tobacco Use in Opioid Agonist Treated Pregnant Women
Acronym
ROSE
Official Title
Tobacco Use in Opioid Agonist Treated Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
smoking, pregnancy, neonatal abstinence syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tobacco abstinent contingent voucher
Arm Type
Experimental
Arm Description
Tobacco abstinent contingent voucher condition
Arm Title
non-contingent
Arm Type
Experimental
Arm Description
Participants receive vouchers non-contingent upon tobacco use status
Arm Title
no voucher
Arm Type
Other
Arm Description
This is the standard care intervention
Intervention Type
Behavioral
Intervention Name(s)
tobacco abstinent contingent
Intervention Description
Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
Intervention Type
Behavioral
Intervention Name(s)
non-contingent
Intervention Description
Participants receive vouchers regardless of tobacco use status
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
this group receives no vouchers
Primary Outcome Measure Information:
Title
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
Time Frame
from treatment entry until 6 weeks post-partum
Secondary Outcome Measure Information:
Title
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters
Time Frame
from treatment entry to 6 weeks posrt-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendree E Jones, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22352784
Citation
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.
Results Reference
derived

Learn more about this trial

Tobacco Use in Opioid Agonist Treated Pregnant Women

We'll reach out to this number within 24 hrs