Trial Outcomes & Findings for Topiramate to Aid Smoking Cessation in Alcohol Dependent Men (NCT NCT00802412)
NCT ID: NCT00802412
Last Updated: 2017-01-31
Results Overview
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Weeks 8-12 of treatment.
Results posted on
2017-01-31
Participant Flow
Participant milestones
| Measure |
Topiramate
The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).
|
Placebo
90 participants, will receive matching placebo
Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
67
|
|
Overall Study
COMPLETED
|
63
|
66
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topiramate to Aid Smoking Cessation in Alcohol Dependent Men
Baseline characteristics by cohort
| Measure |
Topiramate
n=63 Participants
Received active topiramate
|
Placebo
n=66 Participants
Received placebo
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
46.9 years
STANDARD_DEVIATION 9.8 • n=107 Participants
|
47.0 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Gender
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Gender
Male
|
63 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
32 participants
n=99 Participants
|
40 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=99 Participants
|
66 participants
n=107 Participants
|
129 participants
n=206 Participants
|
|
Fagerstrom
|
5.4 units on a scale
STANDARD_DEVIATION 2.0 • n=99 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.6 • n=107 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 8-12 of treatment.This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
Outcome measures
| Measure |
Topiramate
n=63 Participants
12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
|
Placebo
n=66 Participants
12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
|
|---|---|---|
|
4-week Continuous Abstinence From Smoking
|
7.9 percentage of participants abstinent
|
10.6 percentage of participants abstinent
|
SECONDARY outcome
Timeframe: 12-week treatment phase, 36-week combined treatment and follow-upAlcohol or illicit drug use during treatment or follow up.
Outcome measures
| Measure |
Topiramate
n=63 Participants
12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
|
Placebo
n=66 Participants
12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
|
|---|---|---|
|
Percent Relapsing to Any Drinking or Illicit Drug Use
|
31.8 percentage of participants
|
27.3 percentage of participants
|
Adverse Events
Topiramate
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topiramate
n=63 participants at risk
|
Placebo
n=66 participants at risk
|
|---|---|---|
|
Psychiatric disorders
alcohol relapse with suicidal ideation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/66
|
|
Psychiatric disorders
alcohol relapse
|
0.00%
0/63
|
3.0%
2/66 • Number of events 2
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/63
|
1.5%
1/66 • Number of events 1
|
Other adverse events
| Measure |
Topiramate
n=63 participants at risk
|
Placebo
n=66 participants at risk
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
11.1%
7/63 • Number of events 7
|
19.7%
13/66 • Number of events 13
|
|
General disorders
Headache
|
19.0%
12/63 • Number of events 15
|
12.1%
8/66 • Number of events 11
|
|
Nervous system disorders
Paresthesia
|
9.5%
6/63 • Number of events 6
|
18.2%
12/66 • Number of events 12
|
|
General disorders
Loss of appetite
|
14.3%
9/63 • Number of events 9
|
6.1%
4/66 • Number of events 4
|
|
Psychiatric disorders
Reduced concentration
|
12.7%
8/63 • Number of events 8
|
9.1%
6/66 • Number of events 6
|
|
General disorders
Dysgeusia
|
11.1%
7/63 • Number of events 9
|
9.1%
6/66 • Number of events 6
|
|
General disorders
Dizziness
|
6.3%
4/63 • Number of events 4
|
10.6%
7/66 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
2/63 • Number of events 3
|
10.6%
7/66 • Number of events 8
|
|
General disorders
Somnolence
|
9.5%
6/63 • Number of events 6
|
7.6%
5/66 • Number of events 5
|
|
Psychiatric disorders
Depression
|
9.5%
6/63 • Number of events 6
|
4.5%
3/66 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place