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Completed

NCT Number: NCT02159092

The Role of Contingency Management in Waterpipe Smoking Cessation

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.

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Key information

Conditions

Waterpipe Smoking Behavior Health Behavior Pipe Smoking Smoking Smoking Cessation Water Pipe Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Campus Facility, Washington State University

Spokane, Washington, 99202, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contingency Management

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2014
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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