NCT02431611

Brief Summary

Phase 3 Pilot Clinical Trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2015

Typical duration 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

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

April 14, 2015

Last Update Submit

December 15, 2017

Conditions

Nicotine DependencePregnancy

Outcome Measures

Primary Outcomes (1)

  • smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)

    self-reported abstinence verified with cotinine

    at week 36 gestation or greater up to the time of delivery

Secondary Outcomes (1)

  • Self-efficacy (Self-reported confidence scale)

    at week 36 gestation or greater up to the time of delivery

Study Arms (2)

Control condition

ACTIVE COMPARATOR

Control behavioral phone-based smoking cessation intervention

Behavioral: Control condition (phone based smoking cessation counseling)

Biomarker Feedback Intervention

EXPERIMENTAL

Biomarker feedback plus behavioral phone-based smoking cessation intervention

Behavioral: Biomarker feedback (phone based smoking cessation counseling)

Interventions

Biomarker feedback (phone based smoking cessation counseling)BEHAVIORAL

Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling

Biomarker Feedback Intervention
Control condition (phone based smoking cessation counseling)BEHAVIORAL

phone-based behavioral smoking cessation counseling

Control condition

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Alaska Native
  • years or older
  • provide written informed consent
  • be currently pregnant and at \<24 weeks gestation
  • reside in Anchorage and plan to deliver at the ANMC
  • current tobacco user defined as any use of Iqmik, commercial ST, and/or cigarettes during the past 7 days.

You may not qualify if:

  • use of using nicotine replacement therapy or medications for tobacco cessation or participation in a behavioral cessation program within the past 30 days
  • another woman from the same household has enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99577, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Christi A Patten, PhD

    Mayo Clinic

    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
PI

Study Record Dates

First Submitted

April 14, 2015

First Posted

May 1, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)