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Trial record 42 of 439 for:    Methylphenidate

Testing Methylphenidate for Smoking Abstinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00549640
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : November 1, 2010
Last Update Posted : April 19, 2011
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Smoking
Interventions Drug: Methylphenidate
Drug: Placebo
Enrollment 80
Recruitment Details Recruitment for this study began on 03/10/08 and the final subject was randomized to study drug on 11/4/08. All subjects were recruited at Mayo Clinic in Rochester, MN.
Pre-assignment Details After obtaining consent, subjects were screened for study inclusion. If they passed study entry criteria, they were randomized to study. All randomized subjects were included in the analysis.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily) Look alike placebo pill with same dosing schedule as active methylphenidate
Period Title: Overall Study
Started 40 40
Completed 22 [1] 24
Not Completed 18 16
Reason Not Completed
Withdrawal by Subject             6             12
Adverse Event             5             0
Lost to Follow-up             7             4
[1]
For the primary endpoint, subjects who discontinued participation were assumed to be smoking.
Arm/Group Title Methylphenidate Placebo Total
Hide Arm/Group Description osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily) Look alike placebo pill with same dosing schedule as active methylphenidate Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
39
  97.5%
79
  98.8%
>=65 years
0
   0.0%
1
   2.5%
1
   1.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
35.6  (11.0) 38.0  (11.9) 36.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
20
  50.0%
26
  65.0%
46
  57.5%
Male
20
  50.0%
14
  35.0%
34
  42.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
Cigarettes Per Day   [1] 
Mean (Standard Deviation)
Unit of measure:  Cigarettes per day
Number Analyzed 40 participants 40 participants 80 participants
19.7  (7.4) 20.8  (8.2) 20.2  (7.8)
[1]
Measure Description: Self-reported number of cigarettes smoked per day
1.Primary Outcome
Title Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.
Hide Description Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat. subjects with missing information were assumed to be using tobacco.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
Look alike placebo pill with same dosing schedule as active methylphenidate
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
1 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments [Not Specified]
Method Fisher Exact
Comments 1-tailed
2.Primary Outcome
Title Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study
Hide Description Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of study (week 24) and are biochemically confirmed (expired carbon monoxide <= 8 ppm)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). subject who discontinued study participation were counted as using tobacco.
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
Look alike placebo pill with same dosing schedule as active methylphenidate
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
4 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Fisher Exact
Comments 1 tailed test
3.Secondary Outcome
Title The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.
Hide Description The average composite nicotine withdrawal score (using Minnesota Nicotine Withdrawal Scale) change from baseline for the first 14 days following target quit date. Scale scores range from 0 (none) to 4 (severe).
Time Frame baseline and 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was restricted to subjects who had diary information available for the first 14 days following target quit date
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description:
osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
Look alike placebo pill with same dosing schedule as active methylphenidate
Overall Number of Participants Analyzed 27 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.28  (0.42) 0.24  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Methylphenidate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method t-test, 2 sided
Comments For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methylphenidate, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Mixed Models Analysis
Comments analysis performed using daily scores
Time Frame Adverse Events were collected for 8 weeks of study medication. Serious adverse events were collected for the duration for the duration of the study period (6 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Methylphenidate Placebo
Hide Arm/Group Description osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily) Look alike placebo pill with same dosing schedule as active methylphenidate
All-Cause Mortality
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   1/40 (2.50%) 
General disorders     
hospitalization [1]  0/40 (0.00%)  1/40 (2.50%) 
[1]
hospitalization following overdose of alcohol and prescription drugs.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methylphenidate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   17/40 (42.50%)   5/40 (12.50%) 
Gastrointestinal disorders     
nausea  2/40 (5.00%)  1/40 (2.50%) 
General disorders     
Insomnia  5/40 (12.50%)  0/40 (0.00%) 
vivid dreams  2/40 (5.00%)  1/40 (2.50%) 
Nervous system disorders     
Restless  5/40 (12.50%)  2/40 (5.00%) 
Headache  3/40 (7.50%)  1/40 (2.50%) 
Psychiatric disorders     
Anorexia  3/40 (7.50%)  0/40 (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
Layout table for Results Point of Contact information
Name/Title: Dr. Richard D. Hurt
Organization: Mayo Clinic
Phone: 507-266-1944
EMail: nicotineresearch@mayo.edu
Layout table for additonal information
Responsible Party: Richard D. Hurt, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00549640     History of Changes
Other Study ID Numbers: 06-005407
06-006284 ( Other Identifier: Mayo Clinic IRB Number )
First Submitted: October 24, 2007
First Posted: October 26, 2007
Results First Submitted: September 8, 2010
Results First Posted: November 1, 2010
Last Update Posted: April 19, 2011