A clinical trial of adaptive treatment for early smoking cessation relapse

Sponsor:

NIH

Sponsor Study ID:

RO1 CA284649

CTO #:

103902

NCT Number:

NCT06118502

Phase:

N/A

Protocol Type:

Prevention

Age Group:

Adults

Disease Sites:

Study Objectives:

Aim 1: To determine if, among non-responders to an initial course of FDA-approved smoking cessation medication (either varenicline or combination NRT), it is better to continue use of the same medication or to switch to another. Hypothesis: Among smokers who have not yet responded to one FDA-approved medication, switching to another FDA-approved medication will result in greater success at short-term follow-up, using a clinically relevant and objective measure of success (7-days non-smoking with CO < 6ppm), as compared to medication continuation. Aim 2: To determine if, among non-responders to two courses of FDA-approved medications, it is better to continue use of these same medications or switch to a harm reduction alternative (e-cigarette). Hypothesis: Among smokers who have not yet responded to two courses of FDA-approved pharmacotherapy, switching to e-cigarettes will result in greater abstinence from cigarettes at short-term follow-up. Aim 3: To assess 6-month cessation outcomes among smokers who received only FDA-approved cessation medications (varenicline or combination NRT) vs. a harm reduction alternative (e-cigarette). Hypothesis: Among smokers who have not responded to treatment after two courses of pharmacotherapy, a harm reduction approach will result in higher rates of abstinence at 6 months than another course of pharmacotherapy.

eConsent:

Not available

Study Documents:

Open Study Documents
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