NCT00915798

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

November 1, 2016

Enrollment Period

6.5 years

First QC Date

June 4, 2009

Results QC Date

November 2, 2016

Last Update Submit

January 12, 2017

Conditions

SmokingWithdrawal NicotineADHD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • DRD4 Genotype

    one time blood draw

  • Salivary Cotinine

    Once per week for 4 weeks

Study Arms (4)

Smokers with ADHD

Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).

Behavioral: Cigarette smokingBehavioral: Abstinence

Nonsmokers with ADHD

Nonsmokers with ADHD participated in one condition.

Behavioral: Abstinence

Control smokers

Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).

Behavioral: Cigarette smokingBehavioral: Abstinence

Control nonsmokers

Control nonsmokers participated in one condition.

Behavioral: Abstinence

Interventions

Cigarette smokingBEHAVIORAL

Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking a cigarette.

Control smokersSmokers with ADHD
AbstinenceBEHAVIORAL

Participants had an fMRI scan during an experimental task consisting of mathematical problems after smoking abstinence.

Control nonsmokersControl smokersNonsmokers with ADHDSmokers with ADHD

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Commuity sample

You may qualify if:

  • Smokers with ADHD
  • Cigarette smoking for the last year
  • ADHD diagnosis
  • Nonsmokers with ADHD
  • No history of regularly smoking cigarettes
  • ADHD diagnosis
  • Normative control smokers
  • Cigarette smoking for the last year
  • No history and diagnosis of ADHD
  • Normative control nonsmokers
  • No history of regularly smoking cigarettes
  • No history and diagnosis of ADHD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2500 Red Hill Avenue

Santa Ana, California, 92705, United States

Location

Related Publications (2)

  • 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. Epub 2014 Nov 4.

    PMID: 25481571BACKGROUND

  • Gehricke JG, Gevorkian J, Stehli A, Alejo SD, Dawson M, Kopelevich A. Discrepancies in the Validity of Self-Reported Cigarette Smoking in Adults With and Without ADHD. J Dual Diagn. 2019 Jul-Sep;15(3):177-183. doi: 10.1080/15504263.2019.1620399. Epub 2019 Jun 3.

    PMID: 31156069DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for genotyping

MeSH Terms

Conditions

SmokingAttention Deficit Disorder with Hyperactivity

Interventions

Natural Family Planning Methods

Condition Hierarchy (Ancestors)

BehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ContraceptionReproductive TechniquesTherapeutics

Results Point of Contact

Title
Dr. Jean Gehricke
Organization
UC Irvine
jgehrick@uci.edu
949-267-0404

Study Officials

  • Jean-G. Gehricke, Ph.D., M.A.

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

January 13, 2017

Results First Posted

January 13, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)