A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

Cigarette Smoking Clinical Trial

— ADAPT  

Official title:

A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118502
• Other study ID #: 00128175
• Secondary ID: 1R01CA284649-01
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: Tracy T Smith, PhD
• Phone: 8438725164
• Email: smithtra[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.

All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Description:

Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 544
• Est. completion date: March 31, 2028
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Smokers who want to quit

Exclusion Criteria:

• Non-smokers

Related Conditions & MeSH terms

• Cigarette Smoking
• Recurrence
• Smoking Behaviors
• Treatment

Intervention

Behavioral:
• Switching to a different medication
Participants will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4.
• Continued use of the same medication
Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.
• Switching to a harm reduction tobacco product
Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-responders after initial course of FDA-approved medication	7-day point prevalence abstinence at Week 8 among non-responders at Week 4	8 weeks
Secondary	Dependence and duration of longest quit attempt	7-day point prevalence abstinence at Week 12 among non-responders at Week 8.	12 weeks