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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04832360
Other study ID # RCA241570A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date August 1, 2022

Study information

Verified date October 2022
Source University of Georgia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples [DSCs]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control [CTL], dyadic target [DT] FIT or single target [ST] FIT) and tracked across 3 months. The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up.


Description:

The proposed study investigates the feasibility and efficacy of FITs in dual-smoker couples [DSCs]. The core design is a three-group mixed repeated measures design, in which participants are randomized into one of three conditions (control [CTL], dyadic target [DT] FIT or single target [ST] FIT) and tracked across 3 months. During this time, participants will complete a baseline session and a follow-up. Between these visits, all participants will have access to a voluntary brief cessation program (i.e., online psychoeducation created for this study using Beat the Pack materials and resources from NCI, NIH + Nicotine Replacement Therapy [NRT]). The FIT involves monetary incentives for online psychoeducation completion and smoking abstinence at follow-up. In the ST condition, one member of each couple (i.e., the target) will receive monetary incentives; in the DT condition, both members of the couple will receive monetary incentives. This design allows for preliminary consideration of FITs in DSCs and tests whether FITs for both members of the dyad synergistically enhances outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: both members: - age of 18+ - smoke 5+ combustible cigarettes/day - may not have participated in pilot study Exclusion Criteria: - < 8th grade capacity to read/write in English - hospitalization in recent 6 months - current drug or alcohol use disorder - psychotic symptoms - medical exclusion for use of NRT

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial Incentives
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)

Locations

Country Name City State
United States University of Georgia Athens Georgia

Sponsors (1)

Lead Sponsor Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking Abstinence Percentage of participants who have quit smoking by the follow-up study cessation verified biochemically Follow-up study session 3 months post-baseline session
Primary Feasibility of Financial Incentives Treatment in Dyadic-smoker couples as assessed by number of dyads retained in study Number of people who contact the study team; number of complete dyads prescreened; percentage of eligible dyads enrolled; percentage of enrolled dyads retained through follow-up; percentage enrolled participants who drop out due to study procedures/burden; subjective ratings of benefits and costs of participating in study Through study recruitment and study completion, an average of five months
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