Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

About this trial

Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem we will recruit 40 patients for a pilot 2-arm effectiveness trial. We will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Smoked in the past 30 days

Smoke at least 1 cigarette per day when they smoke

≥ 18 years old

Kansas resident

Disqualifiers

Medically ineligible for varenicline

Patient on smoking cessation medication within 2 weeks of admission date

Patient already talked to quitline in the past 2 weeks.

Patients participating in other quit smoking program or research study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health Rewards

    Behavioral

    All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline. In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM).

  • Control

    Behavioral

    All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CounsCM+MedCMExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility outcomes

Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.

Time frame
Week 3 to 12
2

Proportion of quitline calls completed

Completion of the five quitline calls according to Kansas quitline reports

Time frame
Week 12
3

Proportion of varenicline pills taken

Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting

Time frame
Week 12

Secondary outcomes

1

Proportion of patients with biochemically verified smoking abstinence

Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml

Time frame
Week 12
2

Proportion of patients with self-reported smoking abstinence

Past 7 days self-reported smoking abstinence

Time frame
Week 12

Other outcomes

Sponsors and contacts

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University of Kansas Medical Center

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

University of Oklahoma

Collaborator

University of Toronto

Collaborator

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