Nicotine DependenceNCT04832360
Testing Financial Incentive Interventions in Dyadic-Smoker Couples
A study testing Financial Incentives in people with Nicotine Dependence, run by University of Georgia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- both members:
- age of 18+
- smoke 5+ combustible cigarettes/day
- may not have participated in pilot study
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Nicotine Dependence
- Being tested
- Financial Incentives
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesBehavioural
Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)
| Study group | Role | What they receive |
|---|---|---|
| Control (CTL) | Experimental | Participants do not receive financial incentive intervention Receives: Behavioral: Financial Incentives |
| Single Target (ST) | Experimental | One member of each dyadic-smoking couple will receive financial incentive intervention Receives: Behavioral: Financial Incentives |
| Dyadic Target (DT) | Experimental | Both members of each dyadic-smoking couple will receive financial incentive intervention Receives: Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Percentage of targets who have quit smoking by the follow-up study cessation verified biochemically
Measured: Follow-up study session 3 months post-baseline session
Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples
Feasibility of financial incentives treatment in dyadic-smoker couples was assessed by number of individuals retained in study. Retention was separated by condition.
Measured: Through study recruitment and study completion, an average of five months
Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples
Participant subjective ratings of the benefits and costs of participating in the study. Tolerability was defined using eight items assessing the accessibility, benefits, and costs of the study scored on a 1 (strongly disagree) to 7 (strongly agree) scale. Tolerability scores were separated by target and partner and reported by condition.
Measured: Through study recruitment and study completion, an average of five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start15 Jan 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle R Vandellen, University of Georgia
- Investigators
- Michelle R vanDellen, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832360
- Sponsor's protocol ID
- RCA241570A
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2021
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other researchers who request it.
Publications
Andrade FC, Shen Y, MacKillop JM, Beach SRH, vanDellen MR. Dyadic patterns of abstinence from smoking in dual-smoking couples enrolled in a pilot randomized clinical trial. Health Psychol. 2026 May;45(5):528-538. doi: 10.1037/hea0001573. Epub 2026 Jan 29.
PubMed 41609650
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Financial Incentive Interventions in Dyadic-Smoker Couples
- ClinicalTrials.gov ID
- NCT04832360
- Acronym / sponsor ID
- RCA241570A
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (CTL) | Experimental | Behavioral: Financial IncentivesParticipants do not receive financial incentive intervention |
| Single Target (ST) | Experimental | Behavioral: Financial IncentivesOne member of each dyadic-smoking couple will receive financial incentive intervention |
| Dyadic Target (DT) | Experimental | Behavioral: Financial IncentivesBoth members of each dyadic-smoking couple will receive financial incentive intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age of 18+
- smoke 5+ combustible cigarettes/day
- may not have participated in pilot study
Key exclusion criteria (5 listed)
- < 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
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 |
|---|---|---|
| Financial IncentivesFinancial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking) | Behavioural | Control (CTL), Dyadic Target (DT), Single Target (ST) |
Primary outcome
Smoking Abstinence
Time frame: Follow-up study session 3 months post-baseline session
Percentage of targets who have quit smoking by the follow-up study cessation verified biochemically
Feasibility of Financial Incentives Treatment in Dyadic-Smoker Couples
Time frame: Through study recruitment and study completion, an average of five months
Feasibility of financial incentives treatment in dyadic-smoker couples was assessed by number of individuals retained in study. Retention was separated by condition.
Tolerability of Financial Incentives Treatment in Dyadic-Smoker Couples
Time frame: Through study recruitment and study completion, an average of five months
Participant subjective ratings of the benefits and costs of participating in the study. Tolerability was defined using eight items assessing the accessibility, benefits, and costs of the study scored on a 1 (strongly disagree) to 7 (strongly agree) scale. Tolerability scores were separated by target and partner and reported by condition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41609650Andrade FC, Shen Y, MacKillop JM, Beach SRH, vanDellen MR. Dyadic patterns of abstinence from smoking in dual-smoking couples enrolled in a pilot randomized clinical trial. Health Psychol. 2026 May;45(5):528-538. doi: 10.1037/hea0001573. Epub 2026 Jan 29.
- Individual participant dataSharing planned: Yes. Data will be shared with other researchers who request it.
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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.
Michelle R vanDellen, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives in people with Nicotine Dependence, run by University of Georgia 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 4 inclusion and 5 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 24 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smoking Abstinence (time frame: Follow-up study session 3 months post-baseline session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832360, which also lists 1 linked publication.
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 24 Jan 2025.