Trial Outcomes & Findings for Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study (NCT NCT00755716)

NCT ID: NCT00755716

Last Updated: 2017-08-16

Results Overview

The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

57 participants

Primary outcome timeframe

weeks 7-10

Results posted on

2017-08-16

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo (Sugar Pill) Person receives an inactive placebo Placebo (sugar pill):	Topiramate Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.	Topiramate and Nicotine Patch Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Overall Study STARTED	19	19	19
Overall Study COMPLETED	11	11	16
Overall Study NOT COMPLETED	8	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (Sugar Pill) Person receives an inactive placebo Placebo (sugar pill):	Topiramate Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.	Topiramate and Nicotine Patch Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Overall Study Adverse Event	1	4	1
Overall Study Lack of Efficacy	2	0	0
Overall Study Lost to Follow-up	5	3	1
Overall Study work schedule issues	0	1	1

Baseline Characteristics

Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Sugar Pill) n=19 Participants Person receives an inactive placebo Placebo (sugar pill): patients receive	Topiramate n=19 Participants Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.	Topiramate and Nicotine Patch n=19 Participants Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.	Total n=57 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	19 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	57 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	45.4 years STANDARD_DEVIATION 7.6 • n=5 Participants	46.1 years STANDARD_DEVIATION 11.1 • n=7 Participants	50.1 years STANDARD_DEVIATION 9.6 • n=5 Participants	47.2 years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment United States	19 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	57 Participants n=4 Participants

PRIMARY outcome

Timeframe: weeks 7-10

The primary efficacy endpoint was CO-confirmed cigarette abstinence during the last 4 weeks of treatment.

Outcome measures

Outcome measures
Measure	Placebo (Sugar Pill) n=19 Participants Person receives an inactive placebo Placebo (sugar pill): patients receive	Topiramate n=19 Participants Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.	Topiramate and Nicotine Patch n=19 Participants Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Primary Outcome is 4-week Continuous Quit Rate at the End of Treatment.	1 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Measured weekly during weeks 7-10 & the mean of weekly measurements is recorded.

Population: Subjects only needed to have an MNWS at one of these time points (weeks 7-10) to be included in the analysis.

Minnesota Nicotine Withdrawing Scale Scale contains 9 items which are scored 0-4. The total range for the scale is 0-36, where higher scores indicate greater nicotine withdrawal symptoms.

Outcome measures

Outcome measures
Measure	Placebo (Sugar Pill) n=16 Participants Person receives an inactive placebo Placebo (sugar pill): patients receive	Topiramate n=17 Participants Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.	Topiramate and Nicotine Patch n=12 Participants Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
MNWS	5.7 units on a scale Standard Error 1.3	4.9 units on a scale Standard Error 1.2	6.8 units on a scale Standard Error 1.1

Adverse Events

Placebo (Sugar Pill)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Topiramate

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Topiramate & Nicotine Patch

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Cheryl Oncken

UConn Health

Phone: 860-679-3425

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo (Sugar Pill) n=19 participants at risk Person receives an inactive placebo Placebo (sugar pill): patients receive	Topiramate n=19 participants at risk Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks.	Topiramate & Nicotine Patch n=19 participants at risk Subjects receive 10 weeks of topiramate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day and one week taper for a total time of 10 weeks. On the quit date (after 2 weeks of Topiramate medication use), subjects also use 21 mg patch for 7 weeks and on week 8 subjects received 14 mg/day for 3 days then 7 mg for 4 days.
Nervous system disorders Paresthesia	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Psychiatric disorders Fatigue	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	26.3% 5/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Gastrointestinal disorders Loss Of Appetite	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Psychiatric disorders Difficulty with Memory	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Gastrointestinal disorders Weight Loss	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Psychiatric disorders Difficulty Concentrating	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Psychiatric disorders Nervousness/agitation/irritablility	21.1% 4/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	26.3% 5/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
General disorders Change in Sense of Taste	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	31.6% 6/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Psychiatric disorders Depressed Mood	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Gastrointestinal disorders Constipation	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Nervous system disorders Insomnia	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Nervous system disorders Headache	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
General disorders Thirst/Dry Mouth	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	5.3% 1/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Gastrointestinal disorders Nausea/Vomiting	10.5% 2/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	21.1% 4/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
Skin and subcutaneous tissue disorders Rash	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.
General disorders Fever	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	0.00% 0/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.	15.8% 3/19 • We assessed adverse events at each weekly visit from randomization through study completion, an average of 10 weeks.