Dyadic Financial Incentive Treatments for Dual Smoker Couples

NCT06296849 | Recruiting Phase 2

• 1 other identifier: 17460
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief Summary

Smokers partnered with other smokers (i.e., dual-smoker couples) represent \~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment. The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.

Conditions

Smoking, Cigarette

Keywords

smoking cessation; dual-smoker couples; behavioral economics; financial incentives

Outcome Measures

Primary Outcomes (1)

• Point-Prevalence Abstinence at End of Treatment

  % of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired carbon monoxide (CO) \<= 5 ppm

  6 Month

Secondary Outcomes (5)

• Point-Prevalence Abstinence After Treatment

  1 year

• Point-Prevalence Abstinence at First Follow-up

  1 month

• Point-Prevalence Abstinence at Second Follow-up

  3 month

• Partner Point-Prevalence Abstinence

  1 Month, 3 Month, 6 Month, 1 Year

• Smoking Heaviness

  1 Month, 3 Month, 6 Month, 1 Year

Study Arms (3)

No-FIT Treatment-as-Usual (TAU) Condition

NO INTERVENTION

Participants in the no-FIT control condition will not receive incentives.

Single-Target FIT (SFIT)

EXPERIMENTAL

One couple member offered incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups \[1, 3, and 6 Month\]).

Behavioral: Financial Incentive Treatment (FIT)

Dyadic-FIT condition (DFIT)

EXPERIMENTAL

Both couple members offered incentives and tracked across 12 months. Both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition.

Behavioral: Financial Incentive Treatment (FIT)

Interventions

Financial Incentive Treatment (FIT) BEHAVIORAL

In the present study, the investigators will provide financial incentives of $200 for biochemically verified abstinence at each of three time points (1 month, 3 month, and 6 month) following baseline. Additionally, the investigators will provide a bonus of $200 for participants who demonstrate abstinence at each of the time points. This incentive value is consistent with recent research using macro-level financial incentives and incorporates both short-term and long-term incentives to shape behavior.

Dyadic-FIT condition (DFIT); Single-Target FIT (SFIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic relationship duration of at least six months.

You may not qualify if:

• \) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use.

Sponsors & Collaborators

• McMaster University: collaborator
• University of Oklahoma: lead
• University of Kentucky: collaborator
• University of Georgia: collaborator

Study Sites (2)

University of Georgia

Athens, Georgia, 30602, United States

COMPLETED

University of Oklahoma Health Campus

Tulsa, Oklahoma, 74135, United States

RECRUITING

Related Publications (1)

• vanDellen MR, Wright JWC, Zhao B, Cullinan C, Beach SRH, Shen Y, Haskins LB, Schiavone WM, MacKillop JM. Partner-Involved Financial Incentives for Smoking Cessation in Dual-Smoker Couples: A Randomized Pilot Trial. Nicotine Tob Res. 2024 Jan 22;26(2):229-236. doi: 10.1093/ntr/ntad183.

  PMID: 37742229 BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Study Officials

• Michelle R vanDellen, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle R vanDellen, PhD

CONTACT

762-499-4263; Michelle-vanDellen@ou.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: January 18, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Individual participant data (IDP) will become available 6 months after publication or August 2029, whichever comes later.
• Access Criteria: To protect participant anonymity, some identifying information will only be available through coordination with the study principal investigator (PI) (e.g., gender, same sex status, age, race).

Locations

US (2)