Trial Outcomes & Findings for The Reinforcing Mechanisms of Smoking in Adult ADHD (NCT NCT00573859)

NCT ID: NCT00573859

Last Updated: 2011-11-07

Results Overview

Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2011-11-07

Participant Flow

Participant milestones

Measure	ADHD Medication Versus Placebo 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.
Medication Versus Placebo STARTED	27
Medication Versus Placebo COMPLETED	15
Medication Versus Placebo NOT COMPLETED	12
Smoking Versus Abstinence STARTED	27
Smoking Versus Abstinence COMPLETED	15
Smoking Versus Abstinence NOT COMPLETED	12

Reasons for withdrawal

Measure	ADHD Medication Versus Placebo 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.
Medication Versus Placebo Scheduling conflicts	12
Smoking Versus Abstinence Scheduling conflicts	12

Baseline Characteristics

The Reinforcing Mechanisms of Smoking in Adult ADHD

Baseline characteristics by cohort

Measure	ADHD Medication Versus Placebo n=27 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	27.2 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Smokers with ADHD

Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.

Outcome measures

Measure	ADHD Medication Versus Placebo n=15 Participants 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.
The Effects of ADHD Medication Versus Placebo on Cotinine Levels Placebo	274.0 ng/ml Standard Error 70.4
The Effects of ADHD Medication Versus Placebo on Cotinine Levels ADHD medication	180.7 ng/ml Standard Error 33.3

SECONDARY outcome

Timeframe: 4 days

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.

Outcome measures

Measure	ADHD Medication Versus Placebo n=15 Participants 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.
The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. ADHD medication + Smoking	0.40 errors Standard Error 0.1
The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. ADHD medication + Abstinence	1.08 errors Standard Error 0.3
The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. Placebo + Smoking	1.00 errors Standard Error 0.4
The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. Placebo + Abstinence	2.8 errors Standard Error 0.6

SECONDARY outcome

Timeframe: 4 days

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.

Outcome measures

Measure	ADHD Medication Versus Placebo n=15 Participants 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.
The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. ADHD medication + Smoking	92.7 scores on a scale Full Range 2.9 • Interval 75.0 to 123.0
The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. ADHD medication + Abstinence	91.3 scores on a scale Full Range 3.5 • Interval 68.0 to 132.0
The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. Placebo + Smoking	97.0 scores on a scale Full Range 4.8 • Interval 59.0 to 137.0
The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. Placebo + Abstinence	102.0 scores on a scale Full Range 4.8 • Interval 80.0 to 161.0

Adverse Events

ADHD Medication Versus Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean Gehricke, Ph.D.

University of California, Irvine

Phone: 949-824-1834

Email: jgehrick@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place