This trial is active, not recruiting.

Condition smoking
Treatments incentives for participation, incentives for cessation
Sponsor University of Rhode Island
Start date March 2014
End date June 2017
Trial size 880 participants
Trial identifier NCT01826331, DA034041


One of the most important debates in the field of disease prevention is whether financial incentives should be contingent on participation in evidence-based programs for smoking cessation or on actual outcomes, like prolonged abstinence. This study can fill a major knowledge gap in this debate, which is the lack of any population trial that compared the impacts of outcomes- and participation-based incentives in a population of smokers. This research can help policy makers and health service providers choose the incentives approach that provides the most effectiveness, cost-effectiveness and cost-savings for entire populations of smokers.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose health services research
(No Intervention)
Participants will be incentivized for assessments only
Participants will be incentivized for each assessment and for each smoking cessation session they complete
incentives for participation
Participants will receive three smoking cessation programs
Participants will be incentivized for each assessment and biochemically confirmed abstinence at 12 and 24 months
incentives for cessation
Participants will have access to a smoking cessation program

Primary Outcomes

Smoking abstinence
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - smoker Exclusion Criteria: -

Additional Information

Official title Incentives for Participation Versus Outcomes for Population Cessation of Smoking
Principal investigator James O Prochaska, Ph.D.
Description This population-based randomized clinical trial is designed to compare long-term abstinence rates in three groups of smokers: 1. Those incentivized for participation in an evidence-based treatment designed for smokers at each stage of change; 2. Those incentivized for biologically validated prolonged abstinence at 6 and 12 months who could also choose to participate in the TTM (Transtheoretical Model)-tailored intervention; and 3. An assessment only control condition. The Specific Aims are: 1. To assess whether the treatment group incentivized for participation outperforms the control group at 12, 24 and 36 months as hypothesized; 2. To assess whether the treatment group incentivized for prolonged abstinence at 6 and 12 months outperforms the control group at each follow-up as hypothesized; 3. To assess whether the treatment group incentivized for participation outperforms the treatment group incentivized for outcomes at 36 months as hypothesized. 4. To compare the cost-effectiveness of each treatment in a population of mostly unmotivated smokers; The Secondary Aims are: 1. To assess the long-term treatment trajectories of each treatment compared to controls with hypothesized increasing trajectory in the participation contingent incentives and decreasing trajectory in the outcome contingent incentives. 2. To identify mediators of long-term outcomes in each treatment, such as amount of treatment participation, income, severity of smoking, stage of change, self-efficacy, perceived health and intrinsic and extrinsic motivation to quit. 3. To compare cost-savings of each treatment by modeling all additional costs of smoking for employers and smokers.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Rhode Island.