NCT02159092

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

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

First Submitted

Initial submission to the registry

June 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

June 5, 2014

Last Update Submit

December 10, 2015

Conditions

Keywords

WaterpipeSmoking cessationContingency managementDependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • withdrawal symptoms

    5 weeks

Study Arms (2)

Contingency Management

EXPERIMENTAL

Monetary incentives are given for submitting negative saliva cotinine tests.

Behavioral: Contingency Management

Fixed Rate Control

NO INTERVENTION

Fixed amounts of payments are provided for submitting saliva samples

Interventions

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.

Contingency Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be18 years and older
  • Smoked waterpipe average of \>12 times per month for 2 years

You may not qualify if:

  • Smokes cigarettes (self-report)
  • Uses any tobacco product (self-report)
  • Uses illicit drugs (urine analysis for toxicology)
  • Interested in quitting waterpipe smoking (self-report)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Campus Facility, Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Water Pipe SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Pipe SmokingSmokingBehaviorHealth Behavior

Study Officials

  • Kawkab Shishani, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 9, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations