Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers

NCT02599571 | Terminated

• 2 other identifiers: Pro000661441R01HD083404
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.

Conditions

Nicotine Dependence; ADHD

Outcome Measures

Primary Outcomes (3)

• Number of cigarettes smoked per day

  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

  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

  Composite of study dropout, compliance, changes in physical health

  Six weeks

Secondary Outcomes (2)

• Measures of discomfort/dysfunction; withdrawal and depression

  Six weeks

• Measures of other health-related behaviors; dependence measures

  Six weeks

Study Arms (2)

Very low nicotine content cigarettes

OTHER

Reduced nicotine content cigarettes.

Other: Very low nicotine content cigarettes; Other: Conventional nicotine content cigarettes

Conventional nicotine content cigarettes

OTHER

Conventional nicotine content cigarettes.

Other: Very low nicotine content cigarettes; Other: Conventional nicotine content cigarettes

Interventions

Very low nicotine content cigarettes OTHER

Cigarettes containing a reduced amount of nicotine

Also known as: Tobacco, Cigarettes

Conventional nicotine content cigarettes; Very low nicotine content cigarettes

Conventional nicotine content cigarettes OTHER

Cigarettes containing a normal amount of nicotine

Also known as: Tobacco, Cigarettes

Conventional nicotine content cigarettes; Very low nicotine content cigarettes

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Food and Drug Administration (FDA): collaborator
• University of Pittsburgh: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Scott Kollins, Ph.D.

  Duke ADHD Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 6, 2015
• Study Start: March 30, 2016
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (2)