Waterpipe SmokingNCT02159092
The Role of Contingency Management in Waterpipe Smoking Cessation
A study testing Contingency Management in people with Waterpipe Smoking, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Waterpipe Smoking
- What is being tested?
- Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be18 years and older
- Smoked waterpipe average of >12 times per month for 2 years
Who cannot join
- Smokes cigarettes (self-report)
- Uses any tobacco product (self-report)
- Uses illicit drugs (urine analysis for toxicology)
- Interested in quitting waterpipe smoking (self-report)
Trial locations and contacts
1 site in 1 country.
United States1 site
South Campus Facility, Washington State University
Spokane, Washington, 99202
About this study
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.
Read the 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
- Conditions
- Waterpipe Smoking
- Being tested
- Contingency Management
- Keywords
- Waterpipe, Smoking cessation, Contingency management, Dependence
- Medical subject headings
- Water Pipe Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management | Experimental | Monetary incentives are given for submitting negative saliva cotinine tests. Receives: Behavioral: Contingency Management |
| Fixed Rate Control | No intervention | Fixed amounts of payments are provided for submitting saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (1)
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waterpipe SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kawkab shishani, Washington State University
- Investigators
- Kawkab Shishani, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159092
- Sponsor's protocol ID
- 5K01DA037661-02
- Status last verified
- Dec 2015
- First submitted
- 5 Jun 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Contingency Management in Waterpipe Smoking Cessation
- ClinicalTrials.gov ID
- NCT02159092
- Acronym / sponsor ID
- 5K01DA037661-02
- Conditions
- Waterpipe Smoking
- Keywords
- Waterpipe, Smoking cessation, Contingency management, Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingency Management | Experimental | Behavioral: Contingency ManagementMonetary incentives are given for submitting negative saliva cotinine tests. |
| Fixed Rate Control | No intervention | –Fixed amounts of payments are provided for submitting saliva samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be18 years and older
- Smoked waterpipe average of >12 times per month for 2 years
Key exclusion criteria (4 listed)
- Smokes cigarettes (self-report)
- Uses any tobacco product (self-report)
- Uses illicit drugs (urine analysis for toxicology)
- Interested in quitting waterpipe smoking (self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency ManagementMonetary 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. | Behavioural | Contingency Management |
Primary outcome
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.
1 secondary outcome
withdrawal symptoms
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kawkab Shishani, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency Management in people with Waterpipe Smoking, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quitting waterpipe smoking (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.