The Reinforcing Mechanisms of Smoking in Adult ADHD

ADHD Clinical Trial

Official title:

The Reinforcing Mechanisms of Smoking in Adult ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573859
• Other study ID #: 2006-5156
• Secondary ID: NIH grant# DA018
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 12, 2007
• Last updated: September 23, 2011
• Start date: September 2006
• Est. completion date: June 2010

Study information

• Verified date: September 2011
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• ADHD medication
For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
• Placebo
For the placebo condition, participants received placebo pills for two consecutive days.

Locations

Country	Name	City	State
United States	Department of Pediatrics	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effects of ADHD Medication Versus Placebo on Cotinine Levels	Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.	4 days	No
Secondary	The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.	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.	4 days	No
Secondary	The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.	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.	4 days	No