Clinical trial NCT00573859: The Reinforcing Mechanisms of Smoking in Adult ADHD
Official title: The Reinforcing Mechanisms of Smoking in Adult ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ADHD
Keywords: Smoking
ADHD
Stimulant medication
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Effects of ADHD Medication Versus Placebo on Cotinine Levels
timeFrame: 4 days
Secondary outcomes:
measure: The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.
timeFrame: 4 days
measure: The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.
timeFrame: 4 days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Department of Pediatrics
state: California
Study officials:
affiliation: University of California, Irvine
name: Jean G Gehricke, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.