Clinical trial NCT02266784: Contingency Management, Quitting Smoking, and ADHD
Official title: Smoking/Nicotine Dependence in Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cigarette Smoking
Smoking Cessation
Keywords: smoking, smoking cessation, contingency management, ADHD
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-10-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 18-55 years of age
* Male or female; if female of child-bearing potential, must be using an acceptable form of contraception
* ADHD Diagnosis:
* For ADHD Groups: confirmed primary diagnosis, any subtype as determined by the clinician administered CAADID and clinical interview
* For Control Group: NO diagnosis of ADHD as determined by clinician administered CAADID and clinical interview
* ADHD Symptom Ratings:
* For ADHD Groups: T-Score \> 65 on one of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the CAARS
* For Control Group: T-Score \< 60 on all of the DSM-IV relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on both the Self-Report and Observer versions of the CAARS
* Self-report smoking at least 10 cigarettes/day
* Provides an afternoon exhaled carbon monoxide reading of at least 10 ppm.
* Cognitive functioning \> 80 as assessed by the KBIT-II

Exclusion Criteria:

* History of chronic/significant medical condition
* Use of any psychoactive medication in the past 12 months, other than FDA-approved medication for the ADHD group only
* Estimated IQ \< 80 on Kaufmann Brief Intelligence Test, Second Edition
* Has a primary diagnosis of any other Axis I Disorder (determined by the Structured Diagnostic Interview for DSM; SCID) that is significantly impairing and would contraindicate participation in the present study
* Has a primary diagnosis of any Axis II Disorder

Primary outcomes:
measure: Change in motivation to quit smoking, as measured by the Readiness to Change Questionnaire
timeFrame: Baseline to 9 weeks
measure: Change in motivation to quit smoking, as measured by the Treatment Self-Regulation Questionnaire
timeFrame: Baseline to 9 weeks
measure: Change in motivation to quit smoking, as measured by the Perceived Competence Scale for Cessation
timeFrame: Baseline to 9 weeks
measure: Change in motivation to quit smoking, as measured by the Reasons For Quitting questionnaire
timeFrame: Baseline to 9 weeks
measure: Change in readiness to change behavior, as measured by the Readiness to Change Questionnaire
timeFrame: Baseline to 9 weeks
measure: Change in readiness to change behavior, as measured by the Treatment Self-Regulation Questionnaire
timeFrame: Baseline to 9 weeks
measure: Change in readiness to change behavior, as measured by the Perceived Competence Scale for Cessation
timeFrame: Baseline to 9 weeks
measure: Change in readiness to change behavior, as measured by the Reasons For Quitting questionnaire
timeFrame: Baseline to 9 weeks
measure: Comparison of populations in motivation to quit on the Reasons for Quitting Questionnaire
timeFrame: Baseline to 9 weeks
Secondary outcomes:
measure: Change in smoking behavior in ADHD population
timeFrame: Baseline, 3 months, 6 months
measure: Decreasing effects of quitting smoking.
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Scott H Kollins, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: