Trial Outcomes & Findings for Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents (NCT NCT01110434)
NCT ID: NCT01110434
Last Updated: 2020-09-16
Results Overview
Frequency of Cannabis Use (Percent Use Days Per Week)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Weeks 1-6
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Topiramate
Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily)
|
Sugar Pill
Placebo: Placebo (daily)
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
26
|
|
Overall Study
COMPLETED
|
29
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
Baseline characteristics by cohort
| Measure |
Topiramate
n=40 Participants
Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily)
|
Sugar Pill
n=26 Participants
Placebo: Placebo (daily)
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.30 years
STANDARD_DEVIATION 2.03 • n=5 Participants
|
18.81 years
STANDARD_DEVIATION 2.08 • n=7 Participants
|
19.71 years
STANDARD_DEVIATION 2.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-6Frequency of Cannabis Use (Percent Use Days Per Week)
Outcome measures
| Measure |
Topiramate
n=40 Participants
Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily)
|
Sugar Pill
n=26 Participants
Placebo: Placebo (daily)
|
|---|---|---|
|
Cannabis Use
|
55.89 Percentage of use days
Standard Deviation 32.35
|
63.10 Percentage of use days
Standard Deviation 34.91
|
SECONDARY outcome
Timeframe: Weeks 1-6Total Grams of Cannabis Use Per week
Outcome measures
| Measure |
Topiramate
n=40 Participants
Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily)
|
Sugar Pill
n=26 Participants
Placebo: Placebo (daily)
|
|---|---|---|
|
Quantity of Cannabis Use
|
1.87 Grams Per Week
Standard Deviation 2.11
|
2.85 Grams Per Week
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: Weeks 1-6Average Grams of Cannabis Used Per Use Day
Outcome measures
| Measure |
Topiramate
n=40 Participants
Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily)
|
Sugar Pill
n=26 Participants
Placebo: Placebo (daily)
|
|---|---|---|
|
Amount of Cannabis Use Per Use Day
|
0.46 Average Grams Per Use Day
Standard Deviation 0.32
|
0.60 Average Grams Per Use Day
Standard Deviation 0.48
|
Adverse Events
Topiramate
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate
n=40 participants at risk
Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily)
|
Sugar Pill
n=26 participants at risk
Placebo: Placebo (daily)
|
|---|---|---|
|
General disorders
Headache
|
20.0%
8/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
23.1%
6/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
11.5%
3/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Cough, Cold Symptoms
|
12.5%
5/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
19.2%
5/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Injury
|
20.0%
8/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
19.2%
5/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Parasthesias
|
37.5%
15/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
7.7%
2/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Sore Throat
|
10.0%
4/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
7.7%
2/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Runny Nose, Sinus Problems, Sneezing
|
35.0%
14/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
46.2%
12/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Gastrointestinal disorders
Stomach Pain, Cramps
|
5.0%
2/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
11.5%
3/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Eye disorders
Changes in Vision
|
10.0%
4/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
0.00%
0/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
12/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
30.8%
8/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Decrease in Appetite
|
47.5%
19/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
34.6%
9/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Weight Loss
|
50.0%
20/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
23.1%
6/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Psychiatric disorders
Irritability
|
5.0%
2/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
11.5%
3/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Psychiatric disorders
Nervousness
|
10.0%
4/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
0.00%
0/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Psychiatric disorders
Confusion
|
12.5%
5/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
0.00%
0/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Difficulty with Coordination or Balance
|
15.0%
6/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
0.00%
0/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Difficulty with Memory
|
20.0%
8/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
19.2%
5/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Fatigue
|
22.5%
9/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
34.6%
9/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Psychiatric disorders
Anxiety
|
25.0%
10/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
0.00%
0/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
Psychiatric disorders
Depression
|
25.0%
10/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
3.8%
1/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Dizziness
|
25.0%
10/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
7.7%
2/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Difficulty with Concentration or Attention
|
27.5%
11/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
7.7%
2/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Word Finding Difficulties
|
27.5%
11/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
15.4%
4/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Slow Thinking or Reactions
|
30.0%
12/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
15.4%
4/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Drowsiness or Sleepiness
|
30.0%
12/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
50.0%
13/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
|
General disorders
Fever
|
0.00%
0/40 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
7.7%
2/26 • Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place