Association Between Smoking, Brain Activity, Genes, and ADHD

Smoking Clinical Trial

Official title:

Smoking, Neurocircuitry and Genes in Adult ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915798
• Other study ID #: HS 2009-6740
• Secondary ID: K01DA025131
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2009
• Last updated: January 12, 2017
• Start date: July 2009
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study investigated the underlying mechanisms of smoking in young adults by examining the associations between smoking, brain activity, dopamine genes, and attention deficit hyperactivity disorder (ADHD).

Description:

The study investigated the underlying mechanisms of smoking in young adults by examining the associations between smoking, brain activity, dopamine genes, and attention deficit hyperactivity disorder (ADHD). Four groups of young adults were recruited: (1) smokers with ADHD; (2) nonsmokers with ADHD; (3) normative control smokers; and (4) normative control nonsmokers. Smoking was assessed via questionnaires and salivary cotinine levels. Brain activity was examined via functional Magnetic Resonance Imaging (fMRI). Each nonsmoker underwent an fMRI scan during an experimental task consisting of mathematical problems. Smokers underwent two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence. The association between the DRD4-7 repeat allele and smoking was explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Smokers with ADHD

• Cigarette smoking for the last year

• ADHD diagnosis

2. Nonsmokers with ADHD

• No history of regularly smoking cigarettes

• ADHD diagnosis

3. Normative control smokers

• Cigarette smoking for the last year

• No history and diagnosis of ADHD

4. Normative control nonsmokers

• No history of regularly smoking cigarettes

• No history and diagnosis of ADHD

Exclusion Criteria:

• Children under the age of 18

• Adults above the age of 45

• Pregnancy or planning to become pregnant

• Any major medical illness

• Any mental disorders that require medication (except stimulant medication)

• Any contraindications to fMRI scanning

• Not speaking English

Related Conditions & MeSH terms

• ADHD
• Smoking
• Withdrawal Nicotine

Intervention

Behavioral:
• Cigarette smoking
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette.
• Abstinence
Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.

Locations

Country	Name	City	State
United States	2500 Red Hill Avenue	Santa Ana	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gehricke JG, Swanson JM, Duong S, Nguyen J, Wigal TL, Fallon J, Caburian C, Muftuler LT, Moyzis RK. Increased brain activity to unpleasant stimuli in individuals with the 7R allele of the DRD4 gene. Psychiatry Res. 2015 Jan 30;231(1):58-63. doi: 10.1016/j.pscychresns.2014.10.021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Activity	BOLD z-score of smokers with ADHD after abstinence/smoking a cigarette, control smokers after abstinence/smoking a cigarette, nonsmokers with ADHD, and control nonsmokers. All participants performed a mathematical task in the MRI scanner. Higher BOLD z-scores indicate greater brain activation.	One MRI session for nonsmokers and two MRI sessions for smokers
Secondary	DRD4 Genotype		one time blood draw
Secondary	Salivary Cotinine	Average level of salivary cotinine over all time points (microgram/milliliter)	Once per week for 4 weeks