Trial Outcomes & Findings for Testing Methylphenidate for Smoking Abstinence (NCT NCT00549640)

NCT ID: NCT00549640

Last Updated: 2011-04-19

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2011-04-19

Participant Flow

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.

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.

Participant milestones

Measure	Methylphenidate 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)	Placebo Look alike placebo pill with same dosing schedule as active methylphenidate
Overall Study STARTED	40	40
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Measure	Methylphenidate 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)	Placebo Look alike placebo pill with same dosing schedule as active methylphenidate
Overall Study Withdrawal by Subject	6	12
Overall Study Adverse Event	5	0
Overall Study Lost to Follow-up	7	4

Baseline Characteristics

Testing Methylphenidate for Smoking Abstinence

Baseline characteristics by cohort

Measure	Methylphenidate n=40 Participants 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)	Placebo n=40 Participants Look alike placebo pill with same dosing schedule as active methylphenidate	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	35.6 years STANDARD_DEVIATION 11.0 • n=5 Participants	38.0 years STANDARD_DEVIATION 11.9 • n=7 Participants	36.8 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	26 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Cigarettes Per Day	19.7 cigarettes per day STANDARD_DEVIATION 7.4 • n=5 Participants	20.8 cigarettes per day STANDARD_DEVIATION 8.2 • n=7 Participants	20.2 cigarettes per day STANDARD_DEVIATION 7.8 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Intention to Treat. subjects with missing information were assumed to be using tobacco.

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)

Outcome measures

Measure	Methylphenidate n=40 Participants 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)	Placebo n=40 Participants Look alike placebo pill with same dosing schedule as active methylphenidate
Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment.	1 participants	4 participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat (ITT). subject who discontinued study participation were counted as using tobacco.

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)

Outcome measures

Measure	Methylphenidate n=40 Participants 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)	Placebo n=40 Participants Look alike placebo pill with same dosing schedule as active methylphenidate
Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study	4 participants	3 participants

SECONDARY outcome

Timeframe: baseline and 14 days

Population: Analysis was restricted to subjects who had diary information available for the first 14 days following target quit date

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).

Outcome measures

Measure	Methylphenidate n=27 Participants 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)	Placebo n=37 Participants Look alike placebo pill with same dosing schedule as active methylphenidate
The Change in the Average Nicotine Withdrawal Symptom Score From Baseline to 14 Days Post Target Quit Date.	0.28 units on a scale Standard Deviation 0.42	0.24 units on a scale Standard Deviation 0.35

Adverse Events

Methylphenidate

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Methylphenidate n=40 participants at risk 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)	Placebo n=40 participants at risk Look alike placebo pill with same dosing schedule as active methylphenidate
General disorders hospitalization	0.00% 0/40 • 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)	2.5% 1/40 • 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)

Other adverse events

Measure	Methylphenidate n=40 participants at risk 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)	Placebo n=40 participants at risk Look alike placebo pill with same dosing schedule as active methylphenidate
Nervous system disorders Restless	12.5% 5/40 • 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)	5.0% 2/40 • 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)
General disorders Insomnia	12.5% 5/40 • 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)	0.00% 0/40 • 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)
Nervous system disorders Headache	7.5% 3/40 • 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)	2.5% 1/40 • 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)
Psychiatric disorders Anorexia	7.5% 3/40 • 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)	0.00% 0/40 • 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)
General disorders vivid dreams	5.0% 2/40 • 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)	2.5% 1/40 • 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)
Gastrointestinal disorders nausea	5.0% 2/40 • 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)	2.5% 1/40 • 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)

Additional Information

Dr. Richard D. Hurt

Mayo Clinic

Phone: 507-266-1944

Email: nicotineresearch@mayo.edu

Results disclosure agreements

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