Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nicotine Dependence
- Sponsor
- Duke University
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.
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.
Investigators
Eligibility 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 \>
- •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.)
Outcomes
Primary Outcomes
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
Number of cigarettes smoked per day
Time Frame: Six weeks
Self-reported number of cigarettes smoked per day
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
Secondary Outcomes
- Measures of other health-related behaviors; dependence measures(Six weeks)
- Measures of discomfort/dysfunction; withdrawal and depression(Six weeks)