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Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers (ADHDenic)

This study is currently recruiting participants.
Verified May 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02599571
First Posted: November 6, 2015
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Food and Drug Administration (FDA)
University of Pittsburgh
Information provided by (Responsible Party):
Duke University
  Purpose
The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.

Condition Intervention
Nicotine Dependence ADHD Other: Very low nicotine content cigarettes Other: Conventional nicotine content cigarettes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Number of cigarettes smoked per day [ Time Frame: Six weeks ]
  • Composite measure of influence of reduced nicotine content on ADHD symptoms measured by ADHD Rating Scale and Clinical Global Impressions Scale along with related measures of cognition measured by the N-Back Task and the Continuous Performance Test [ Time Frame: Six weeks ]
    Composite of ADHD symptom questionnaires, inhibitory control, working memory

  • Composite measure of outcomes associated with acceptability; withdrawal measured by the MNWS and compliance measured by Time-Line Follow-Back questionnaire and daily self-report cigarette use [ Time Frame: Six weeks ]
    Composite of study dropout, compliance, changes in physical health


Secondary Outcome Measures:
  • Measures of discomfort/dysfunction; withdrawal and depression [ Time Frame: Six weeks ]
    Withdrawal scale and depression measures

  • Measures of other health‐related behaviors; dependence measures [ Time Frame: Six weeks ]
    Drug and alcohol use questionnaires


Estimated Enrollment: 350
Actual Study Start Date: January 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Very low nicotine content cigarettes
Reduced nicotine content cigarettes.
Other: Very low nicotine content cigarettes
Other Names:
  • Tobacco
  • Cigarettes
Other: Conventional nicotine content cigarettes
Other Names:
  • Tobacco
  • Cigarettes
Conventional nicotine content cigarettes
Conventional nicotine content cigarettes.
Other: Very low nicotine content cigarettes
Other Names:
  • Tobacco
  • Cigarettes
Other: Conventional nicotine content cigarettes
Other Names:
  • Tobacco
  • Cigarettes

Detailed Description:
The purpose of this study is to examine the effects of very low nicotine content (VLNC) cigarettes on smoking behavior, psychiatric symptoms and functioning, and acceptability and adverse outcomes in young adult smokers with ADHD. Participants will attend a screening session, 2 baseline sessions, 6 experimental sessions, and a 30 day follow-up visit. Participants will be asked to smoke only the study cigarettes that we provide for 6 weeks.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 - 40
  • Smoke an average of 5-40 cigarettes per day for at least 1 year
  • Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 6)
  • Primary diagnosis of ADHD, any subtype as assessed by the CAADID; T-Score > 65 on one of the DSM- V relevant scales (Inattentive Symptoms, Hyperactive-Impulsive Symptoms, Total Symptoms or ADHD Index) on the Self-Report version of the CAARS; Clinician Rated ADHD-RS score >24.
  • Cognitive functioning > 80 as assessed by the KBIT-II

Exclusion Criteria:

  • Intention to quit smoking in the next 30 days
  • Currently seeking treatment for smoking cessation
  • Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
  • A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
  • Using other tobacco products more than 9 days in the past 30 days
  • Significant unstable medical conditions (any significant change in a serious medical condition occurring during the past 3 months including cardiovascular disease, COPD, and cancer, as determined by the study physician at each site)
  • Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician at each site)
  • Any Axis I Psychiatric Disorder as assessed by the MINI that is significantly impairing and/or would contraindicate participation in the study
  • Psychiatric medication changes in the past 3 months including new prescriptions, changes in dosages or discontinuation of medications
  • Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP (Marijuana will be tested for but will not be an exclusionary criterion, participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded, participants failing the toxicology screen will be allowed to re‐screen once. These participants will need to be re‐consented before being rescreened to ensure they have received adequate informed consent.)
  • Breath alcohol level > 0.01 (Participants failing the breath alcohol screen will be allowed to re‐screen once. These participants will need to be re‐consented before being rescreened to ensure they have received adequate informed consent.)
  • Current diagnosis of DSM alcohol or drug use disorder (except for nicotine)
  • Pregnant, trying to become pregnant or breastfeeding
  • Smoking 'roll your own cigarettes' exclusively
  • Currently taking anticonvulsant medications including: Phenytoin [Brand Name: Dilantin], Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol], Oxcarbazepine [Brand Name: Trileptal], Primidone [Brand Name: Mysoline], Phenobarbital
  • CO reading >80 ppm
  • Systolic BP between 90 and 160 (If below 90 then asymptomatic. Participants failing for blood pressure will be allowed to re‐screen once.)
  • Diastolic BP between 50 and 100 (If below 50 then asymptomatic. Participants failing for blood pressure will be allowed to re‐screen once.)
  • Heart rate between 45 and 115 bpm (If below 45 then asymptomatic. Participants failing for heart rate will be allowed to re‐screen once.)
  • Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years.
  • Inability to independently read and comprehend the consent form and other written study materials and measures.
  • Having participated in a research study during the past three months in which the participant: Smoked a cigarette that was not his/her usual brand cigarette for more than one day, used any tobacco products beyond normal use for more than one day, used any nicotine replacement products or smoking cessation medications for more than one day
  • Any previous experience using SPECTRUM cigarettes
  Contacts and Locations
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): NCT02599571


Contacts
Contact: Anthony DeVito, M.D. 919-684-1377 anthony.devito@duke.edu
Contact: Lauren Pacek, Ph.D. 919-684-5437 Lauren.pacek@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Anthony DeVito, M.D.    919-684-1377    anthony.devito@duke.edu   
Contact: Lauren Pacek, Ph.D.    9196845437    lauren.pacek@duke.edu   
Principal Investigator: Scott Kollins, Ph.D.         
Principal Investigator: F. Joe McClernon, Ph.D.         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kelly Glew       glewkc@upmc.edu   
Principal Investigator: Brooke Molina, Ph.D.         
Principal Investigator: Eric Donny, Ph.D.         
Sponsors and Collaborators
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Food and Drug Administration (FDA)
University of Pittsburgh
Investigators
Principal Investigator: Scott Kollins, Ph.D. Duke ADHD Program
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02599571     History of Changes
Other Study ID Numbers: Pro00066144
1R01HD083404 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 2015
First Posted: November 6, 2015
Last Update Posted: June 7, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Nicotine
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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