NCT01207310

Brief Summary

The proposed study tests the efficacy of using pager-assisted messages combined with nicotine patches in facilitating smoking cessation and relapse prevention in a 2-arm randomized clinical trial. The hypothesis is that the proportion of biochemically-verified quitters at 3 and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric pagers for 3 months along with individual smoking cessation counseling and nicotine patches will be greater that the proportion of biochemically-verified quitters who receive only individual smoking cessation counseling and nicotine patches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2003

Typical duration 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

Study Start

First participant enrolled

May 1, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

September 21, 2010

Last Update Submit

October 29, 2017

Conditions

Smoking Cessation

Keywords

smokingsmoking of 10 cigarettes per day

Outcome Measures

Primary Outcomes (1)

  • biologically-validated point prevalence smoking cessation

    Abstinence from cigarettes "even a puff", other tobacco products and nicotine replacement for seven days at the 12 month follow-up date as validated by salivary cotinine less than 15 ng/ml

    12 months after enrollment

Secondary Outcomes (1)

  • continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement

    12 months after enrollment

Study Arms (2)

Pager Arm

EXPERIMENTAL

Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.

Behavioral: smoking cessation counselingDrug: Nicotine patchDevice: alphanumeric pager

Control Arm

ACTIVE COMPARATOR

Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.

Behavioral: smoking cessation counselingDrug: Nicotine patch

Interventions

smoking cessation counselingBEHAVIORAL

two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9

Also known as: Behavioral counseling
Control ArmPager Arm
Nicotine patchDRUG

8 weeks' worth of nicotine patches

Also known as: Nicoderm
Control ArmPager Arm
alphanumeric pagerDEVICE

therapeutic messages to be delivered for three months

Also known as: Pager-assisted text messaging
Pager Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoking 10 or more cigarettes per day
  • aged 18 or older
  • motivated to quit smoking and prepared to set a quit date
  • willing to use nicotine patches
  • ability to come to therapy sessions and be followed by telephone

You may not qualify if:

  • individuals who are psychotic
  • severely depressed
  • organically brain impaired
  • actively abusing alcohol or other substances, and/or who have been drug dependent during the past six months
  • terminally ill
  • unable to be contacted by phone,currently using nicotine replacement or smoking cessation medications
  • those with contraindications to nicotine patches, female smokers who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Smoking CessationSmoking

Interventions

Behavior TherapyTobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Timothy P Carmody, Ph.D

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Sciences Clinical professor

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

May 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

US(1)