Trial Outcomes & Findings for Gabapentin for Smoking Cessation (NCT NCT00578552)

Last Updated: 2011-04-19

Results Overview

Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question "Have you used any type of tobacco, even a puff, in the past 7 days?" and (b) Expired Carbon Monoxide equal or less then 8 parts per million.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

12 weeks following start of medication

Results posted on

2011-04-19

Participant Flow

Recruitment began on 08/07/2007 and completed on 12/10/2008. Interested subjects who passed a phone pre-screen were seen at a medical clinic (Mayo Clinic in Rochester, MN and Franciscan Skemp Medical Center in Lacrosse, WI) for consenting and additional study procedures to determine eligibility.

Participant milestones

Participant milestones
Measure	Placebo Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 1800 mg /Day Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 2700 mg/Day Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Overall Study STARTED	27	27	26
Overall Study COMPLETED	12	13	11
Overall Study NOT COMPLETED	15	14	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gabapentin for Smoking Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=27 Participants Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 1800 mg /Day n=27 Participants Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 2700 mg/Day n=26 Participants Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	27 Participants n=7 Participants	26 Participants n=5 Participants	80 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	41.0 years STANDARD_DEVIATION 11.1 • n=5 Participants	41.1 years STANDARD_DEVIATION 9.5 • n=7 Participants	40.7 years STANDARD_DEVIATION 13.5 • n=5 Participants	40.9 years STANDARD_DEVIATION 11.3 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	50 Participants n=4 Participants
Cigarettes per day	20.0 cigarettes per day STANDARD_DEVIATION 6.6 • n=5 Participants	23.7 cigarettes per day STANDARD_DEVIATION 6.9 • n=7 Participants	20.9 cigarettes per day STANDARD_DEVIATION 7.9 • n=5 Participants	21.5 cigarettes per day STANDARD_DEVIATION 7.2 • n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks following start of medication

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 1800 mg /Day n=27 Participants Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 2700 mg/Day n=26 Participants Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco	5 participants	4 participants	0 participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Gabapentin - 1800 mg /Day

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Gabapentin - 2700 mg/Day

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=27 participants at risk Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 1800 mg /Day n=27 participants at risk Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 2700 mg/Day n=26 participants at risk Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.8% 1/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
Injury, poisoning and procedural complications Alcohol Intoxication	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).

Other adverse events

Other adverse events
Measure	Placebo n=27 participants at risk Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 1800 mg /Day n=27 participants at risk Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.	Gabapentin - 2700 mg/Day n=26 participants at risk Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
General disorders Dizziness	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	14.8% 4/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	15.4% 4/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Decreased Concentration	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	11.1% 3/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Edema	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	7.4% 2/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Sleep Disturbance	11.1% 3/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Ataxia	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.8% 1/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Dry Mouth	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	7.4% 2/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Fatigue	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	7.4% 2/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Headache	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Nausea	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Rash	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.8% 1/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Hand Tremors	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.8% 1/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Increased Energy	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.7% 1/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).
General disorders Polyuria	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	0.00% 0/27 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).	3.8% 1/26 • All adverse events were collected for the duration of the treatment phase (up to 12 weeks following start of medication). SERIOUS adverse events were collected for the duration of the study (6 months).

Additional Information

Amit Sood

Mayo Clinic

Phone: 507-266-1944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place