Tobacco Cessation Treatment for Pregnant Alaska Natives

NCT00379444 | Completed Phase 1 DMC

• 2 other identifiers: 1711-055R01DA025156-03
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop a culturally appropriate tobacco cessation behavioral intervention for Alaska Native women who are pregnant and who use tobacco. We will examine the feasibility of the intervention in terms of recruitment and retention of participants, acceptability to patients and prenatal health care providers, and the potential effectiveness of the tobacco use intervention.

Conditions

Tobacco Use

Keywords

tobacco, intervention, tobacco cessation, ALaska Natives,; Native Americans, pregnancy, women

Outcome Measures

Primary Outcomes (2)

• Tobacco abstinence, feasibility (recruitment and retention),

  end of pregnancy

• acceptability of the intervention to the women and providers.

  week 6

Interventions

Standard intervention (counseling + self-help written materials) BEHAVIORAL

counseling

Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video) BEHAVIORAL

counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For pilot testing of the intervention, we will recruit 70 Alaska Native adult pregnant women (10 in Phase 1, 60 in Phase 2) at their first prenatal visit. To be eligible, the participant must: (1) be 18 years of age or older, (2) provide written informed consent, (3) be willing and able to participate in all aspects of the study, (4) be \<24 weeks pregnant, (4) self-report any use of Iqmik, commercial ST, and/or cigarette smoking during the past 7 days, (5) plan to make a serious attempt to stop tobacco use within the next 30 days, (6) have access to a working telephone or provide phone number of a family member, and (7) have access to a working television and VCR in the home or other location.

You may not qualify if:

• Women will be excluded if: (1) they are currently (past 30 days) participating in any tobacco treatment or (2) if there is another study participant from the same household.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation

Interventions

Counseling; S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Christi A Patten, P

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: November 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 9, 2012

Record last verified: 2006-09

Locations

US (1)