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Clinical Trial Summary

The overall goal of the study is to evaluate how motivation and readiness for change are influenced in the context of a smoking cessation attempt. A total of 60 adult (i.e. age 18-55) smokers (N=40 with ADHD; N=20 without ADHD) who are interested in quitting will be enrolled into a 3-arm trial allocated as follows. Twenty of the ADHD smokers and the 20 non-ADHD smokers will be assigned to a traditional 8-week contingency management intervention in which monetary payments will be made contingent upon biologically verified evidence of smoking abstinence. The 20 additional ADHD smokers will be assigned to a treatment-as-usual condition (nicotine replacement; supportive counseling). During the treatment phase, subjects will be required to answer questions 4x/week in their daily lives via an EMA (Ecological Momentary Assessment). Specific Aim 1: To assess motivation to quit smoking and readiness for change prior to a quit attempt in treatment seeking ADHD and non-ADHD smokers. Hypothesis 1a: The investigators hypothesize that prior to a quit attempt, smokers with ADHD will exhibit significantly lower levels of intrinsic motivation to quit, and equal or higher levels of extrinsic motivation to quit compared to smokers without ADHD. Hypothesis 1b: The investigators hypothesize that smokers with ADHD will exhibit relatively less readiness for change than smokers without ADHD. Specific Aim 2: To assess how baseline levels of motivation to quit and readiness for change are influenced during a quit attempt as a function of both ADHD status and treatment modality. Hypothesis 2a. The investigators hypothesize that the CM intervention will result in relatively greater change in extrinsic motivation to quit versus intrinsic motivation to quit, and that this effect will be more pronounced among ADHD smokers. Hypothesis 2b: The investigators hypothesize that overall motivation to quit (intrinsic and extrinsic) and readiness for change will be significantly influenced by the CM intervention versus treatment as usual among ADHD smokers. Exploratory Aim 1: To assess the relative efficacy of a CM intervention versus treatment as usual in smokers with ADHD. The investigators hypothesize that CM will be more effective for promoting short-term (4-8 weeks) smoking abstinence, as well as for promoting longer-term (3-6 months) smoking cessation. Exploratory Aim 2: To assess the associations among smoking withdrawal/craving, affect, ADHD symptoms, and motivation to quit/readiness for change. The investigators hypothesize that higher levels of motivation and readiness for change will be associated with lower levels of self-reported withdrawal, craving, and negative affect.


Clinical Trial Description

Individuals with ADHD have altered reinforcement/motivational functioning that are likely related to risk for smoking and recalcitrance for quitting. The investigators lab has demonstrated that the abstinence-induced reinforcing effects of cigarette smoking are more pronounced in ADHD smokers. However, in spite of these increases and demonstrated differences in withdrawal severity, interventions that provide reinforcement contingent on abstinence appear to work well for smokers with ADHD. To date, no studies have explicitly investigated how motivational processes are associated with smoking cessation attempts in ADHD smokers. The proposed pilot research is therefore highly innovative since it will evaluate how these processes change and influence outcomes during two different kinds of smoking cessation interventions. The project will also provide important pilot data on potential differences between ADHD and non-ADHD smokers in the context of a contingency management (CM) trial, which will help guide the development of more refined and targeted cessation interventions for this high risk group of smokers. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02266784
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date October 2014
Completion date December 8, 2017

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