Clinical trial NCT01135173: Waterpipe Cessation Intervention Study
Official title: Pilot Test of a Cessation Intervention for Waterpipe Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: Smoking Cessation, Waterpipe
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a two-group parallel arm randomized clinical trial, to be conducted at the Syrian Center for Tobacco Studies (SCTS) in Aleppo, Syria.

Detailed description: The study is a two-group parallel arm randomized clinical trial, to be conducted at the Syrian Center for Tobacco Studies (SCTS) in Aleppo, Syria. Subjects will be recruited by flyers, ads, and word of mouth. Smokers who are interested in receiving free stop-smoking assistance as part of a research study will be asked to contact the study office at the SCTS.

Eligibility will be determined by a brief phone screen to determine age, number of years as a smoker and current amount smoked per week, and medical history. Individuals who meet these requirements will be invited to an orientation/screening session at the SCTS to learn more about the study. At the orientation/screening session, the study will be described to interested individuals, their questions will be answered, and those interested in participating will be asked to sign the informed consent document. Participants then will provide baseline demographic information (age, gender, ethnicity, residence, marital status, education, occupation, income) and smoking related information (smoking history, level of dependence, interest in quitting, medical history), and answer other study questionnaires (e.g., self-efficacy, stages of change, and withdrawal symptoms, depression or mood scale). Body weight will be assessed with a calibrated balance-beam scale.

Participants will then be randomized to one of two intervention groups. Subjects in arm A will receive a brief (approximately 15 minute) motivational and educational intervention, delivered by a trained physician from the SCTS, plus written self-help materials. The self-help materials will be adapted and translated into Arabic from existing validated materials from the American Cancer Society and the University of Memphis School of Public Health.

Subjects in Arm B will receive behavioral counseling intervention conducted by a trained physician at the SCTS cessation clinic. Both self-help materials and behavioral intervention will be adapted from established clinical practice guidelines for cigarette smokers (Fiore et al., 2008), experience gained at SCTS with cigarette smokers, and information about the waterpipe gained from previous epidemiological, ethnographic, and clinical studies conducted by the SCTS. Subjects will be requested to do "homework" before the session to facilitate this process. Subjects will be asked to identify high-risk situations and difficulties in previous cessation attempts and will be walked through a series of suggestions in the event of a slip. We also will provide 3 brief (approximately 10 minute) phone calls to subjects during the 90 day follow-up period. These calls are used to identify early relapse, encourage participants, and provide support. In addition, they are used to review materials and information provided during the sessions.

All subjects (Arms A and B) will undergo follow-up assessment at 3 months post-cessation. Data collected at the 3-month follow-up will include expired air carbon monoxide level and several self-report measures, including smoking status, stage of change, and depressive symptomatology. In addition, subjects will be administered a semi-structured questionnaire to assess the perceived usefulness and appropriateness of several features of the cessation intervention (e.g., helpfulness of the interventionist and self-help materials, convenience of the timing and location of the sessions, and usefulness of the phone calls), along with suggestions for improving the intervention. All subjects will receive reminder phone call before the follow-up visits.

All intervention providers will undergo six hours of training for smoking cessation intervention counseling. This training will include general training on intervention delivery, based on current clinical practice standards in developed countries and specific training on study protocols using standardized intervention training materials developed at the University of Memphis.

Eligibility criteria: Inclusion Criteria:

* Adults (18-60 years)
* regular water pipe smokers in Aleppo(at least twice per week for past year)
* interested in quitting
* access to a telephone

Exclusion Criteria:

* unstable cardiovascular, psychiatric, or other debilitating diseases
* inability to provide informed consent.

Primary outcomes:
measure: Smoking cessation
timeFrame: 3 months post-cessation
Secondary outcomes:
measure: Stage of change
timeFrame: 3 months post-cessation
measure: Depressive symptomatology
timeFrame: 3 months post-cessation
measure: Intervention acceptability
timeFrame: 3 months post-cessation
measure: Fagerström Test for Nicotine Dependence (FTND)
timeFrame: 3 months post-cessation
measure: Social Support
timeFrame: 3 months post-cessation
measure: Smoking-specific self-efficacy
timeFrame: 3 months post-cessation
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Syrian Center for Tobacco Studies
Study officials:
affiliation: The University of Memphis and The Syrian Center for Tobacco Studies
name: Kenneth D. Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: