Trial Outcomes & Findings for Levetiracetam XR in Very Heavy Drinkers (NCT NCT00970814)
NCT ID: NCT00970814
Last Updated: 2014-08-28
Results Overview
A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
Weeks 5-14
Results posted on
2014-08-28
Participant Flow
Interested candidates responded by telephone to advertisements at 5 academic centers in the United States between November 2009 and May 2010.
Must be alcohol dependent (DSM-IV criteria); and drinking very heavily (10 or more drinks/drinking day men; 8 or more drinks /drinking day women) 40% of the days during any consecutive 60-day interval during the 90-day period before the clinic screening visit, with at least 1 heavy drinking day occurring within the 14 days before randomization.
Participant milestones
| Measure |
Sugar Pill and BBCET
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
Levetiracetam and Brief Behavioral Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
64
|
|
Overall Study
COMPLETED
|
58
|
50
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Levetiracetam XR in Very Heavy Drinkers
Baseline characteristics by cohort
| Measure |
Sugar Pill and BBCET
n=66 Participants
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
n=64 Participants
Levetiracetam and Brief Behavioral Therapy
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
41.7 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
44 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=99 Participants
|
64 participants
n=107 Participants
|
130 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 5-14A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Outcome measures
| Measure |
Sugar Pill and BBCET
n=66 Participants
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
n=64 Participants
Levetiracetam and Brief Behavioral Therapy
|
|---|---|---|
|
The Percentage of Subjects With no Heavy Drinking Days During Study Weeks 5 Through 14.
|
18.2 percentage of subjects
12
|
14.1 percentage of subjects
9
|
PRIMARY outcome
Timeframe: Study Weeks 5-14A heavy drinking day is 5+ drinks per day for men and 4+ drinks per day for women based on self report.
Outcome measures
| Measure |
Sugar Pill and BBCET
n=66 Participants
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
n=64 Participants
Levetiracetam and Brief Behavioral Therapy
|
|---|---|---|
|
The Percentage of Heavy Drinking Days Per Week During Study Weeks 5 Through 14.
|
41.2 percentage of heavy drinking days
Standard Error 4.39
|
45.8 percentage of heavy drinking days
Standard Error 4.97
|
SECONDARY outcome
Timeframe: Study Weeks 5-14based on self report
Outcome measures
| Measure |
Sugar Pill and BBCET
n=66 Participants
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
n=64 Participants
Levetiracetam and Brief Behavioral Therapy
|
|---|---|---|
|
The Number of Drinks Per Drinking Day Study Weeks 5-14.
|
6.3 drinks per day
Standard Error 0.58
|
7.1 drinks per day
Standard Error 0.6
|
Adverse Events
Sugar Pill and BBCET
Serious events: 10 serious events
Other events: 60 other events
Deaths: 0 deaths
Levetiracetam and BBCET
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugar Pill and BBCET
n=66 participants at risk
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
n=64 participants at risk
Levetiracetam and Brief Behavioral Therapy
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Surgical and medical procedures
Alcohol Detoxification
|
1.5%
1/66 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
Head Injury
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Vascular disorders
Blood Clot
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Nervous system disorders
Syncope
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
Masochism
|
4.5%
3/66 • Number of events 3
|
1.6%
1/64 • Number of events 1
|
|
Immune system disorders
Anaphylactic Reaction
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
Suicide Attempt
|
1.5%
1/66 • Number of events 1
|
0.00%
0/64
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/66
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
Sugar Pill and BBCET
n=66 participants at risk
Placebo and Brief Behavioral Compliance Enhancement Therapy
|
Levetiracetam and BBCET
n=64 participants at risk
Levetiracetam and Brief Behavioral Therapy
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
6/66 • Number of events 8
|
10.9%
7/64 • Number of events 8
|
|
Gastrointestinal disorders
Dry Mouth
|
7.6%
5/66 • Number of events 5
|
7.8%
5/64 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
24.2%
16/66 • Number of events 21
|
21.9%
14/64 • Number of events 23
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
8/66 • Number of events 13
|
7.8%
5/64 • Number of events 18
|
|
General disorders
Cold Sweat
|
1.5%
1/66 • Number of events 1
|
6.2%
4/64 • Number of events 5
|
|
General disorders
Fatigue
|
24.2%
16/66 • Number of events 26
|
53.1%
34/64 • Number of events 47
|
|
General disorders
Irritability
|
19.7%
13/66 • Number of events 19
|
25.0%
16/64 • Number of events 19
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
6.1%
4/66 • Number of events 5
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/66
|
6.2%
4/64 • Number of events 4
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.6%
5/66 • Number of events 5
|
6.2%
4/64 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.1%
8/66 • Number of events 11
|
17.2%
11/64 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.6%
5/66 • Number of events 5
|
12.5%
8/64 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
2/66 • Number of events 3
|
6.2%
4/64 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.5%
1/66 • Number of events 1
|
9.4%
6/64 • Number of events 7
|
|
Nervous system disorders
Agitation
|
4.5%
3/66 • Number of events 3
|
7.8%
5/64 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
10.6%
7/66 • Number of events 8
|
12.5%
8/64 • Number of events 13
|
|
Nervous system disorders
Headache
|
33.3%
22/66 • Number of events 47
|
34.4%
22/64 • Number of events 36
|
|
Nervous system disorders
Paraesthesia
|
15.2%
10/66 • Number of events 13
|
7.8%
5/64 • Number of events 8
|
|
Nervous system disorders
Restlessness
|
6.1%
4/66 • Number of events 4
|
9.4%
6/64 • Number of events 6
|
|
Nervous system disorders
Somnolence
|
10.6%
7/66 • Number of events 8
|
15.6%
10/64 • Number of events 10
|
|
Nervous system disorders
Tremor
|
6.1%
4/66 • Number of events 4
|
3.1%
2/64 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
24.2%
16/66 • Number of events 21
|
14.1%
9/64 • Number of events 12
|
|
Psychiatric disorders
Depressed Mood
|
24.2%
16/66 • Number of events 26
|
18.8%
12/64 • Number of events 22
|
|
Psychiatric disorders
Insomnia
|
22.7%
15/66 • Number of events 17
|
23.4%
15/64 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
2/66 • Number of events 2
|
9.4%
6/64 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.5%
1/66 • Number of events 3
|
7.8%
5/64 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
7.6%
5/66 • Number of events 7
|
15.6%
10/64 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
3/66 • Number of events 5
|
12.5%
8/64 • Number of events 11
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
6.1%
4/66 • Number of events 8
|
1.6%
1/64 • Number of events 1
|
|
Psychiatric disorders
Anger
|
4.5%
3/66 • Number of events 3
|
6.2%
4/64 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
4/66 • Number of events 4
|
6.2%
4/64 • Number of events 8
|
|
Vascular disorders
Hypertension
|
6.1%
4/66 • Number of events 6
|
3.1%
2/64 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place