NCT00984724

Brief Summary

The goal of this research study is to learn the effectiveness of telephone-based counseling on helping smokers change their smoking patterns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
639

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

September 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

5.7 years

First QC Date

September 23, 2009

Last Update Submit

October 6, 2016

Conditions

Smoking CessationSmoking

Keywords

SmokingMotivation and Problem SolvingMAPSLow Income SmokersHCHD community clinicsTelephone-based counseling

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Tobacco Abstinence

    Prolonged abstinence refers to abstinence beginning with initiation of the intervention and including a grace period. Prolonged abstinence measure utilizes the Society for Research on Nicotine and Tobacco's recommendation for determining relapse (i.e., 7 consecutive days of smoking or smoking in each of 2 consecutive weeks). Abstinence at all follow-ups will be biochemically verified using a carbon monoxide level of \<10ppm. Saliva samples collected for cotinine tests at the baseline and 24 month follow-up visits. Saliva samples analyzed for cotinine, a metabolic byproduct of nicotine that provides an estimate of nicotine consumption. A saliva cotinine level of \<20 ng/ml considered as abstinent.

    24 months

Study Arms (6)

Standard Treatment

EXPERIMENTAL

Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Referral to Quitline.

Behavioral: Standard Treatment (ST)Behavioral: Quitline

MAPS-6

EXPERIMENTAL

Standard Treatment (ST) plus 6 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period.

Behavioral: Standard Treatment (ST)Behavioral: Telephone CounselingBehavioral: Quitline

MAPS-12

EXPERIMENTAL

Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline.

Behavioral: Standard Treatment (ST)Behavioral: Telephone CounselingBehavioral: Quitline

Standard Treatment + NRT

EXPERIMENTAL

Standard Treatment (ST): Mailed Packet with standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months). Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.

Behavioral: Standard Treatment (ST)Behavioral: QuitlineBehavioral: Nicotine Replacement Therapy (NRT)

MAPS-6 + NRT

EXPERIMENTAL

Standard Treatment (ST) plus 6 proactive telephone counseling sessions; delivered 4 times (at Baseline, 6, 12, and 18 months). 6 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.

Behavioral: Standard Treatment (ST)Behavioral: Telephone CounselingBehavioral: QuitlineBehavioral: Nicotine Replacement Therapy (NRT)

MAPS-12 + NRT

EXPERIMENTAL

Standard Treatment (ST) plus 12 proactive telephone counseling sessions; ST delivered 4 times (at Baseline, 6, 12, and 18 months). 12 MAPS proactive telephone counseling sessions over 2-year period. Referral to Quitline. Nicotine replacement therapy (NRT) consisting of 300 pieces of nicotine gum issued at baseline visit.

Behavioral: Standard Treatment (ST)Behavioral: Telephone CounselingBehavioral: QuitlineBehavioral: Nicotine Replacement Therapy (NRT)

Interventions

Standard Treatment (ST)BEHAVIORAL

Mailing of packet of materials including a letter referring smokers to the Texas Quitline, nicotine replacement therapy when participants are ready to quit and standard self-help materials; ST delivered a total of 4 times (at Baseline, 6, 12, and 18 months).

MAPS-12MAPS-12 + NRTMAPS-6MAPS-6 + NRTStandard TreatmentStandard Treatment + NRT
Telephone CounselingBEHAVIORAL

MAPS-6: 6 MAPS proactive telephone counseling sessions delivered over a 2-year period MAPS-12: 12 MAPS proactive telephone counseling sessions over a 2-year period

MAPS-12MAPS-12 + NRTMAPS-6MAPS-6 + NRT
QuitlineBEHAVIORAL

Letter referring participants to a Quitline providing quit smoking services.

MAPS-12MAPS-12 + NRTMAPS-6MAPS-6 + NRTStandard TreatmentStandard Treatment + NRT
Nicotine Replacement Therapy (NRT)BEHAVIORAL

300 pieces of nicotine gum issued at baseline visit.

MAPS-12 + NRTMAPS-6 + NRTStandard Treatment + NRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCHD Patient or is at or below 200% of the poverty guideline
  • years of age or older
  • Current smoker
  • History of at least one cigarette per day for the past year
  • Not ready to quit in the next 30 days
  • Valid home address
  • Functioning telephone number
  • Can speak, read, and understand English
  • Register "5" or more on a carbon monoxide breath test

You may not qualify if:

  • Other household members enrolled in this study
  • Enrolled in any other smoking study during the past 90 days
  • Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
  • Regular use of tobacco products other than cigarettes
  • Pregnancy or lactation
  • Active substance dependence (exclusive of nicotine dependence)
  • Use of bupropion or nicotine products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

    PMID: 37335995DERIVED

Related Links

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Larkin L. Strong, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 25, 2009

Study Start

January 1, 2011

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

US(1)