Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborators:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Eugene Somoza, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00253747
First received: November 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
Results First Received: July 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: ADHD
Smoking
Interventions: Drug: Osmotic-Release Methylphenidate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between December 2005 and January 2008. Six study sites recruited participants: 2 substance abuse community treatment programs, 2 Attention Deficit Hyperactivity Disorder (ADHD) clinics and 2 smoking cessation clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Osmotic-Release Methylphenidate (OROS-MPH) For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.

Participant Flow:   Overall Study
    Osmotic-Release Methylphenidate (OROS-MPH)     Osmotic-Release Methylphenidate (OROS-MPH) - Placebo  
STARTED     127     128  
COMPLETED     103     101  
NOT COMPLETED     24     27  
Lost to Follow-up                 13                 14  
Withdrawal by Subject                 10                 11  
Administrative Discharge (1), Other (2)                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Osmotic-Release Methylphenidate (OROS-MPH) For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
Total Total of all reporting groups

Baseline Measures
    Osmotic-Release Methylphenidate (OROS-MPH)     Osmotic-Release Methylphenidate (OROS-MPH) - Placebo     Total  
Number of Participants  
[units: participants]
  127     128     255  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     127     128     255  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.1  ± 10.4     37.5  ± 9.6     37.8  ± 10.0  
Gender  
[units: participants]
     
Female     50     61     111  
Male     77     67     144  
Region of Enrollment  
[units: participants]
     
United States     127     128     255  



  Outcome Measures
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1.  Primary:   Prolonged Abstinence   [ Time Frame: Weeks 7-10 ]

2.  Secondary:   Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale   [ Time Frame: Baseline and Study weeks 1,4,7,9,11 ]

3.  Secondary:   Point-prevalence Abstinence   [ Time Frame: Week 11 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Dr. Theresa Winhusen
Organization: University of CIncinnati
phone: 513-487-7800
e-mail: winhusen@carc.uc.edu


No publications provided by University of Cincinnati

Publications automatically indexed to this study:

Responsible Party: Eugene Somoza, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00253747     History of Changes
Other Study ID Numbers: NIDA-CTN-0029, 5U10DA013732
Study First Received: November 13, 2005
Results First Received: July 16, 2012
Last Updated: August 17, 2012
Health Authority: United States: Federal Government