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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition ADHD
Interventions Drug: ADHD medication
Drug: Placebo
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ADHD Medication Versus Placebo
Hide Arm/Group Description Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
Period Title: Medication Versus Placebo
Started 27
Completed 15
Not Completed 12
Reason Not Completed
Scheduling conflicts             12
Period Title: Smoking Versus Abstinence
Started 27
Completed 15
Not Completed 12
Reason Not Completed
Scheduling conflicts             12
Arm/Group Title ADHD Medication Versus Placebo
Hide Arm/Group Description Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
27.2  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
4
  14.8%
Male
23
  85.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title The Effects of ADHD Medication Versus Placebo on Cotinine Levels
Hide Description Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Smokers with ADHD
Arm/Group Title ADHD Medication Versus Placebo
Hide Arm/Group Description:
Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: ng/ml
ADHD medication 180.7  (33.3)
Placebo 274.0  (70.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADHD Medication Versus Placebo
Comments A 2 (ADHD medication versus Placebo) repeated measure ANOVA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADHD Medication Versus Placebo
Hide Arm/Group Description:
Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: errors
ADHD medication + Smoking 0.40  (0.1)
ADHD medication + Abstinence 1.08  (0.3)
Placebo + Smoking 1.00  (0.4)
Placebo + Abstinence 2.8  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADHD Medication Versus Placebo
Comments Four-way repeated measure ANOVA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ADHD Medication Versus Placebo
Hide Arm/Group Description:
Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: scores on a scale
ADHD medication + Smoking
92.7
(75 to 123)
ADHD medication + Abstinence
91.3
(68 to 132)
Placebo + Smoking
97.0
(59 to 137)
Placebo + Abstinence
102.0
(80 to 161)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADHD Medication Versus Placebo
Comments Friedman's two-way analysis of variance by ranks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman's two analysis of ranks
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ADHD Medication Versus Placebo
Hide Arm/Group Description Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
All-Cause Mortality
ADHD Medication Versus Placebo
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ADHD Medication Versus Placebo
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ADHD Medication Versus Placebo
Affected / at Risk (%)
Total   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jean Gehricke, Ph.D.
Organization: University of California, Irvine
Phone: 949-824-1834
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573859     History of Changes
Other Study ID Numbers: 2006-5156
NIH grant# DA018752
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: August 15, 2011
Results First Posted: November 7, 2011
Last Update Posted: November 7, 2011