The Role of Contingency Management in Waterpipe Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
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.

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

Official Title
-----------------
The Role of Contingency Management in Waterpipe Smoking Cessation

Conditions
-----------------
Waterpipe Smoking

Intervention / Treatment
-----------------
* Behavioral: Contingency Management


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management<br>Monetary incentives are given for submitting negative saliva cotinine tests. | Behavioral: Contingency Management<br>* 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.<br>|
| No Intervention: Fixed Rate Control<br>Fixed amounts of payments are provided for submitting saliva samples | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quitting waterpipe smoking | 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. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| withdrawal symptoms | 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. | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Waterpipe, Smoking cessation, Contingency management, Dependence