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

January 23, 2020 updated by: Duke University
The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Very low nicotine content cigarettes
Reduced nicotine content cigarettes.
Other: Very low nicotine content cigarettes
Cigarettes containing a reduced amount of nicotine
Other Names:
  • Tobacco
  • Cigarettes
Other: Conventional nicotine content cigarettes
Cigarettes containing a normal amount of nicotine
Other Names:
  • Tobacco
  • Cigarettes
Other: Conventional nicotine content cigarettes
Conventional nicotine content cigarettes.
Other: Very low nicotine content cigarettes
Cigarettes containing a reduced amount of nicotine
Other Names:
  • Tobacco
  • Cigarettes
Other: Conventional nicotine content cigarettes
Cigarettes containing a normal amount of nicotine
Other Names:
  • Tobacco
  • Cigarettes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of cigarettes smoked per day
Time Frame: Six weeks
Self-reported number of cigarettes smoked per day
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
Six weeks
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
Six weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measures of discomfort/dysfunction; withdrawal and depression
Time Frame: Six weeks
Withdrawal scale and depression measures
Six weeks
Measures of other health-related behaviors; dependence measures
Time Frame: Six weeks
Drug and alcohol use questionnaires
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Food and Drug Administration (FDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Kollins, Ph.D., Duke ADHD Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00066144
  • 1R01HD083404 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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