- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159092
The Role of Contingency Management in Waterpipe Smoking Cessation
December 10, 2015 updated by: kawkab shishani, Washington State University
Tobacco use kills more than 500,000 people in the United States each year.
Although the use of cigarettes has declined, the use of other tobacco products has remained steady.
Waterpipe smoking is a common form of tobacco smoking after cigarettes in the U.S. In fact, in 2007 the American Lung Association issued a policy alert to warn consumers about this first new tobacco trend of the 21st century (American Lung Association, 2007).
Few studies have been conducted on waterpipe smoking to investigate its harmful effects.
Furthermore, no known studies have evaluated treatments for smoking cessation in waterpipe smokers.
This study aims to test the role of contingency management (CM) in promoting abstinence from waterpipe smoking for 5 weeks verified by salivary cotinine and to characterize self-reported nicotine withdrawal symptoms.
Based on the alarming growth rate over a short period of time in waterpipe tobacco smoking, there is a critical need for clinical research to investigate treatment modalities targeting smoking cessation for waterpipe smokers.
Given the evidence for the role of CM in promoting abstinence from many types of drug use, investigation of the utility of CM for waterpipe smoking cessation is important and timely.
Although Nicotine Replacement Therapy is the mainstay treatment for treating nicotine dependence delivered through cigarettes, the intermittent use patterns that characterize waterpipe smoking suggest that CM may be more effective in promoting waterpipe smoking cessation.
The evidence based knowledge generated in this study may assist in the translation of the treatment program into public health practice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Contingency Management (CM) has been used successfully to treat tobacco addiction.
CM is a powerful drug abuse treatment modality for facilitating change in drug use behaviors.
The utility of CM as a treatment for waterpipe smoking is logical, but needs to be evaluated as a tool in the treatment of waterpipe smoking.
The primary objective of this research plan is to test the role of CM in promoting abstinence from waterpipe tobacco smoking.
The specific aims of the research include: specific aim 1: Conduct a feasibility study to test if CM promotes abstinence from nicotine delivered through waterpipe; specific aim 2: Characterize self-reported nicotine withdrawal symptoms.
A randomized clinical trial involving eligible participants who are randomly assigned with equal allocation to either Contingency Management (CM) or Fixed Rate Control (FRC) will be conducted.
A 2-group (CM versus FRC) x 10 (repeated measures) mixed-model design will be used.
Participants in this study will be followed for 5 weeks during which smoking abstinence will be measured 10 times.
Reinforcement in the form of monetary payment delivered contingent on the participant's salivary cotinine will be provided
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Spokane, Washington, United States, 99202
- South Campus Facility, Washington State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be18 years and older
- Smoked waterpipe average of >12 times per month for 2 years
Exclusion Criteria:
- Smokes cigarettes (self-report)
- Uses any tobacco product (self-report)
- Uses illicit drugs (urine analysis for toxicology)
- Interested in quitting waterpipe smoking (self-report)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contingency Management
Monetary incentives are given for submitting negative saliva cotinine tests.
|
Monetary incentive for the CM groups is contingent on a saliva cotinine reading that indicates smoking abstinence.
Participants were assessed 10 times (Mondays/Thursdays) for abstinence from smoking waterpipe verified by saliva cotinine.
The maximum monetary incentives this group can receive is $192.50.
The CM groups followed an escalating schedule where: 1) the dollar amount of the incentive increases by $.50 as long as the participant is abstinent at each visit;; and 2) resets to the starting incentive ($14) if the participant was non-compliant at the previous visit, but is compliant at the current visit.
Also, Participants were given $10 bonus for every three consecutive compliant visits.
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No Intervention: Fixed Rate Control
Fixed amounts of payments are provided for submitting saliva samples
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quitting waterpipe smoking
Time Frame: 5 weeks
|
Quitting waterpipe smoking will be assessed using saliva cotinine test twice a week for five weeks.
Also, participants will be asked at each visit if they have smoked waterpipe during the past days between visits.
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5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
withdrawal symptoms
Time Frame: 5 weeks
|
Withdrawal symptoms will be assessed using the Minnesota Withdrawal Scale-Revised (MNWS-R) and the Questionnaire of Smoking Urges (QSU).
These self-report measures will be completed twice a week for five weeks.
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5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kawkab Shishani, PhD, Washington State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 5, 2014
First Submitted That Met QC Criteria
June 5, 2014
First Posted (Estimate)
June 9, 2014
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 5K01DA037661-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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