NCT01135173

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
Last Updated

June 10, 2010

Status Verified

March 1, 2010

Enrollment Period

1.6 years

First QC Date

June 1, 2010

Last Update Submit

June 9, 2010

Conditions

Smoking Cessation

Keywords

Smoking Cessation, Waterpipe

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    The endpoint of cessation will be defined as no self-reported tobacco use, confirmed by expired carbon monoxide of less than 10ppm, at the 3 month post-cessation follow-up visit. Three indicators of cessation will be assessed, including prolonged abstinence (no smoking after two weeks post-quit date), continuous abstinence (no smoking after the quit date), and point-prevalent abstinence (no smoking for the past 7 days).

    3 months post-cessation

Secondary Outcomes (6)

  • Stage of change

    3 months post-cessation

  • Depressive symptomatology

    3 months post-cessation

  • Intervention acceptability

    3 months post-cessation

  • Fagerström Test for Nicotine Dependence (FTND)

    3 months post-cessation

  • Social Support

    3 months post-cessation

  • +1 more secondary outcomes

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Motivational and educational intervention, delivered by a trained physician from the SCTS plus written self-help materials.

Behavioral: Waterpipe smoking cessation

Arm B

EXPERIMENTAL

Behavioral counseling intervention conducted by a trained physician at the SCTS cessation clinic. Subjects complete "homework" before the session to facilitate this process. Subjects are asked to identify high-risk situations and difficulties in previous cessation attempts and are walked through a series of suggestions in the event of a slip. Three brief (approximately 10 minute) phone calls are provided 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.

Behavioral: Waterpipe smoking cessation

Interventions

Waterpipe smoking cessationBEHAVIORAL

The main objective of this study is to compare two levels of intensity of a behavioral intervention for waterpipe smoking cessation, using a randomized controlled trial design. In this trial, brief motivational intervention with self-help materials will be compared with intensive behavioral counseling with four sessions, in order to test the efficacy of each of these interventions. This pilot testing will help us; 1) test the potential efficacy of the developed intervention, 2) fine-tune the intervention in terms of content and format, and 3) assess issues related to recruitment and retention. Thus, feedback from participants and intervention staff will form an essential part of this pilot study to assess the adopted approaches and suggest appropriate modifications.

Arm AArm B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syrian Center for Tobacco Studies

Aleppo, Syria

Location

MeSH Terms

Conditions

Smoking CessationWater Pipe Smoking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorPipe SmokingSmoking

Study Officials

  • Kenneth D. Ward, PhD

    The University of Memphis and The Syrian Center for Tobacco Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 2, 2010

Study Start

November 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 10, 2010

Record last verified: 2010-03

Locations

SY(1)