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Pager-Assisted Smoking Cessation Treatment

NCT ID: NCT01207310

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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A total of 224 current smokers were enrolled in a randomized controlled smoking cessation trial. Participants were community-living adult smokers of ≥10 cigarettes per day during the pre-enrollment week who were interested in quitting and recruited from the local area by means of print, media, and online advertisements. To be eligible, they needed to be smoking 10 or more cigarettes per day, aged 18 or older, motivated to quit smoking, prepared to set a quit date, willing to use nicotine patches, and able to come to therapy sessions and be followed by telephone. Participants in the pager treatment were provided with alpha-numeric pagers free of charge for three months. Using specially-designed communication software, text messages were sent to participants aimed at facilitating motivation to quit, cessation strategies, and coping skills to maintain abstinence. Participants in both treatment groups were seen for two 60-minute sessions of standard smoking cessation counseling, and received three follow-up phone calls and two months of nicotine patches.

Conditions

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Smoking Cessation

Keywords

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smoking smoking of 10 cigarettes per day

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pager Arm

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.

Group Type EXPERIMENTAL

smoking cessation counseling

Intervention Type BEHAVIORAL

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

Nicotine patch

Intervention Type DRUG

8 weeks' worth of nicotine patches

alphanumeric pager

Intervention Type DEVICE

therapeutic messages to be delivered for three months

Control Arm

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

Group Type ACTIVE_COMPARATOR

smoking cessation counseling

Intervention Type BEHAVIORAL

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

Nicotine patch

Intervention Type DRUG

8 weeks' worth of nicotine patches

Interventions

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smoking cessation counseling

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

Intervention Type BEHAVIORAL

Nicotine patch

8 weeks' worth of nicotine patches

Intervention Type DRUG

alphanumeric pager

therapeutic messages to be delivered for three months

Intervention Type DEVICE

Other Intervention Names

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Behavioral counseling Nicoderm Pager-assisted text messaging

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Timothy Carmody

Health Sciences Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy P Carmody, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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11RT0009

Identifier Type: -

Identifier Source: org_study_id