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Contingency Management, Quitting Smoking, and ADHD (ADQUIT)

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ClinicalTrials.gov Identifier: NCT02266784
Recruitment Status : Recruiting
First Posted : October 17, 2014
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Cigarette Smoking Smoking Cessation Behavioral: Contingency Management (CM) Drug: Transdermal nicotine skin patches (i.e. Habitrol) Other: Supportive Counseling Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking/Nicotine Dependence in Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : October 2014
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Contingency Management (CM)
ADHD (N=20) & CTRL (N=20). Participants will earn compensation, based upon smoking abstinence via a Contingency Management (CM) system. This level of compensation will increase by the same amount each visit based upon abstinence. In addition, escalating bonus payments will be available for evidence of continued abstinence. The first 10 visits will be daily weekdays. The following 9 visits will be over three weeks. The final 3 treatment visits will occur weekly. The 2nd & 3rd type visits CM payments will be based upon monitoring participants' cotinine levels. A missed visit or elevated CO level will lead to 1) no CM payment for that day; 2) resetting the contingencies such that the next CO sample that is below the criterion will result in payment equal to the first day. If there is a lapse, participants' contingencies will be reinstated at their previous highest level post 3 abstinent days. Also follow-up visits at 3 and 6 months.
Behavioral: Contingency Management (CM)
Treatment as Usual
ADHD (N=20). Transdermal nicotine skin patches (i.e. Habitrol) will be used along with supportive counseling in the treatment as usual groups. Visit schedules will coincide with the visit schedules for the CM groups (daily visits for 1st 2 weeks, 3X weekly visits for weeks 3-5, 1x weekly visit for weeks 6-8). A standard regimen of nicotine replacement with which the study team has experience will be used: four weeks of 21 mg/d beginning on the QD, two weeks of 14 mg/d and two weeks of 7 mg/d. Also follow-up visits at 3 and 6 months.
Drug: Transdermal nicotine skin patches (i.e. Habitrol)
Other: Supportive Counseling



Primary Outcome Measures :
  1. Change in motivation to quit smoking, as measured by the Readiness to Change Questionnaire [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Readiness to Change Questionnaire (RCQ) is a measure designed to assess attitudes toward quitting smoking.

  2. Change in motivation to quit smoking, as measured by the Treatment Self-Regulation Questionnaire [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Treatment Self-Regulation Questionnaire measures autonomous motivation.

  3. Change in motivation to quit smoking, as measured by the Perceived Competence Scale for Cessation [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Perceived Competence Scale for Cessation measures perceived competence to quit.

  4. Change in motivation to quit smoking, as measured by the Reasons For Quitting questionnaire [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Reasons For Quitting questionnaire measures relative levels of intrinsic versus extrinsic motivation to quit smoking.

  5. Change in readiness to change behavior, as measured by the Readiness to Change Questionnaire [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Readiness to Change Questionnaire (RCQ) is a measure designed to assess attitudes toward quitting smoking.

  6. Change in readiness to change behavior, as measured by the Treatment Self-Regulation Questionnaire [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Treatment Self-Regulation Questionnaire measures autonomous motivation.

  7. Change in readiness to change behavior, as measured by the Perceived Competence Scale for Cessation [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Perceived Competence Scale for Cessation measures perceived competence to quit.

  8. Change in readiness to change behavior, as measured by the Reasons For Quitting questionnaire [ Time Frame: Baseline to 9 weeks ]
    During the treatment period, participants will answer at least 4 times weekly, questionnaires to assess motivation for behavior change, autonomy, and interest in quitting. The Reasons For Quitting questionnaire measures relative levels of intrinsic versus extrinsic motivation to quit smoking.

  9. Comparison of populations in motivation to quit on the Reasons for Quitting Questionnaire [ Time Frame: Baseline to 9 weeks ]
    The study team will compare the change in scores for extrinsic and intrinsic motivation to quit on the Reasons for Quitting Questionnaire in the ADHD and non-ADHD groups assigned to receive CM.


Secondary Outcome Measures :
  1. Change in smoking behavior in ADHD population [ Time Frame: Baseline, 3 months, 6 months ]
    This outcome is based both upon the treatment period and follow-up visits at 3 and 6 months. CM is proposed to be a potential more effective treatment in an ADHD population in the short and longer term, in comparison to treatment as usual. This will be measured by urine cotinine level and residual Carbon Monoxides levels from samples provided by participants.

  2. Decreasing effects of quitting smoking. [ Time Frame: Baseline, 3 months, 6 months ]
    This outcome assesses overall whether increased motivation and readiness for behavior change (i.e. quit smoking), potentially associated CM, will decrease negative aspects of quitting. These include smoking withdrawal/craving, affect, and impact on ADHD symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266784


Contacts
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Contact: Scott H Kollins, Ph.D. 919.681.0014 scott.kollins@duke.edu
Contact: Tony D McLaurin, MSPH 919.668.4127 tony.mcclaurin@dm.duke.edu

Locations
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United States, North Carolina
Duke Child and Family Study Center Recruiting
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Scott H Kollins, Ph.D. Duke University Health System

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02266784     History of Changes
Other Study ID Numbers: Pro00055228
2K24DA023464-06A1 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: February 2019
Keywords provided by Duke University:
smoking, smoking cessation, contingency management, ADHD
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action