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The Reinforcing Mechanisms of Smoking in Adult ADHD

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ClinicalTrials.gov Identifier: NCT00573859
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : November 7, 2011
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 14, 2007
Results First Submitted Date  ICMJE August 15, 2011
Results First Posted Date  ICMJE November 7, 2011
Last Update Posted Date November 7, 2011
Study Start Date  ICMJE September 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2011)
The Effects of ADHD Medication Versus Placebo on Cotinine Levels [ Time Frame: 4 days ]
Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
The effects of smoking versus abstinence in interaction with stimulant medication versus placebo on ADHD symptoms, moods, and behavior. [ Time Frame: 4 days ]
Change History Complete list of historical versions of study NCT00573859 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2011)
  • The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. [ Time Frame: 4 days ]
    In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.
  • The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. [ Time Frame: 4 days ]
    The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
To examine associations between smoking-induced task performance assessed by the CPT and smoking-induced changes in ADHD symptoms assessed by the electronic diary. [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Reinforcing Mechanisms of Smoking in Adult ADHD
Official Title  ICMJE The Reinforcing Mechanisms of Smoking in Adult ADHD
Brief Summary

Whereas the smoking prevalence rates in the general population are declining, rates among people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be elevated. Smoking may be a form of self-medication in people with ADHD, which has specific reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and arousal, or a combination of both. In addition, the reinforcing effects of smoking may be potentiated by stimulant medication.

The study examined the reinforcing effects of ad libitum smoking with and without ADHD medication in adult smokers with clinically diagnosed ADHD. Participants were adults with ADHD. The effects of two day of ADHD medication compared to two days on placebo for were studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the Continuous Performance Task and nicotine withdrawal symptoms were examined in response to ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo medication + smoking versus placebo medication + abstinence.

The study identified the reinforcing mechanisms of smoking in interaction with ADHD medication. The findings will contribute to a better understanding of nicotine addiction and facilitate the development of targeted smoking cessation and prevention programs for individuals with ADHD and other people with deficiencies in impulse control and excessive risk taking.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: ADHD medication
    For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
    Other Names:
    • Dextroamphetamine
    • Amphetamine mixed salts
    • Atomoxetine
    • O-Methylphenidate
    • Lisdexamfetamine
  • Drug: Placebo
    For the placebo condition, participants received placebo pills for two consecutive days.
Study Arms  ICMJE Experimental: ADHD medication versus placebo
For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication (e.g., Dextroamphetamine; Amphetamine mixed salts; Atomoxetine; O-Methylphenidate; Lisdexamfetamine). For the placebo condition, a placebo pill was administered.
Interventions:
  • Drug: ADHD medication
  • Drug: Placebo
Publications * Gehricke JG, Hong N, Wigal TL, Chan V, Doan A. ADHD medication reduces cotinine levels and withdrawal in smokers with ADHD. Pharmacol Biochem Behav. 2011 May;98(3):485-91. doi: 10.1016/j.pbb.2011.02.021. Epub 2011 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2009)
27
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
40
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • An age of 18 to 45 years
  • A history of ADHD
  • Current diagnosis of ADHD according to clinical criteria
  • Current treatment with stimulant medication
  • Smoking of 10 cigarettes or more per day

Exclusion Criteria:

  • Treatment for any major medical illness such as cancer, heart disease, diabetes, skin diseases, current major depressive episode, and schizophrenia even if currently controlled by medication
  • Current pregnancy, as measured by a pregnancy test (Clear Blue Easy, Unipath, Bedford, UK), or planning to become pregnant within the next 6 months. These individuals will not be included because smoking may cause harm to the unborn fetus
  • Nursing mothers
  • Non-English speaking people, because the majority of measurements used in the study have not been validated in languages other than English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00573859
Other Study ID Numbers  ICMJE 2006-5156
NIH grant# DA018752
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean G Gehricke, Ph.D. University of California, Irvine
PRS Account University of California, Irvine
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP