The Reinforcing Mechanisms of Smoking in Adult ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADHD medication
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for ADHD focused on measuring Smoking, ADHD, Stimulant medication
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
Sites / Locations
- Department of Pediatrics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADHD medication versus placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT00573859
First Posted
December 12, 2007
Last Updated
September 23, 2011
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00573859
Brief Title
The Reinforcing Mechanisms of Smoking in Adult ADHD
Official Title
The Reinforcing Mechanisms of Smoking in Adult ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Smoking, ADHD, Stimulant medication
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADHD medication versus placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ADHD medication
Other Intervention Name(s)
Dextroamphetamine, Amphetamine mixed salts, Atomoxetine, O-Methylphenidate, Lisdexamfetamine
Intervention Description
For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
For the placebo condition, participants received placebo pills for two consecutive days.
Primary Outcome Measure Information:
Title
The Effects of ADHD Medication Versus Placebo on Cotinine Levels
Description
Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.
Description
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.
Time Frame
4 days
Title
The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.
Description
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.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean G Gehricke, Ph.D.
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21356232
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.
Results Reference
result
Learn more about this trial
The Reinforcing Mechanisms of Smoking in Adult ADHD
We'll reach out to this number within 24 hrs