The Reinforcing Mechanisms of Smoking in Adult ADHD

NCT00573859 | Completed Phase 1 Results DMC

• 2 other identifiers: 2006-5156NIH grant# DA018752
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Smoking; ADHD; Stimulant medication

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.

  4 days

• The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.

  4 days

Study Arms (1)

ADHD medication versus placebo

EXPERIMENTAL

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.

Drug: ADHD medication; Drug: Placebo

Interventions

ADHD medication DRUG

For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.

Also known as: Dextroamphetamine, Amphetamine mixed salts, Atomoxetine, O-Methylphenidate, Lisdexamfetamine

ADHD medication versus placebo

Placebo DRUG

For the placebo condition, participants received placebo pills for two consecutive days.

ADHD medication versus placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Department of Pediatrics

Irvine, California, 92612, United States

Location

Related 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.

  PMID: 21356232 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Smoking

Interventions

Dextroamphetamine; Atomoxetine Hydrochloride; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Propylamines

Results Point of Contact

• Title: Jean Gehricke, Ph.D.
• Organization: University of California, Irvine

jgehrick@uci.edu

949-824-1834

Study Officials

• Jean G Gehricke, Ph.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 7, 2011
• Results First Posted: November 7, 2011

Record last verified: 2011-09

Locations

US (1)