Clinical trial NCT01207310: Pager-Assisted Smoking Cessation Treatment
Official title: Pager-Assisted Smoking Cessation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking
smoking of 10 cigarettes per day
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: biologically-validated point prevalence smoking cessation
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement
timeFrame: 12 months after enrollment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Timothy P Carmody, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: