Trial Outcomes & Findings for A New Pharmacotherapy for Alcohol Dependence: Olanzapine (NCT NCT00746785)
NCT ID: NCT00746785
Last Updated: 2014-03-20
Results Overview
Drinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the "Time Line Follow Back" method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time.
COMPLETED
PHASE3
304 participants
up to 36 weeks
2014-03-20
Participant Flow
A double-blind, placebo-controlled 3 (Medication: olanzapine 5 mg, olanzapine 2.5 mg, vs. placebo) x 10 (Time: Baseline, 1, 2, 4, 6, 8, 10, 12, 24, 36 weeks). Subjects will be randomly assigned to receive either olanzapine (5 mg), olanzapine (2.5 mg), or placebo for a period of 12 weeks.
There is a discrepancy between number of participants enrolled, and number of participants started, due to some participants' ineligibility at screening. Therefore, the number enrolled refers to those participants who signed a consent form, whereas, the number started refers to those participants who were randomized to a treatment condition.
Participant milestones
| Measure |
A - 2.5 mg Olanzapine
2.5 mg Olanzapine
olanzapine : 2.5 mg
|
B - 5 mg Olanzapine
5 mg Olanzapine
olanzapine : 5 mg
|
C - Placebo
placebo : placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
46
|
40
|
|
Overall Study
COMPLETED
|
14
|
21
|
13
|
|
Overall Study
NOT COMPLETED
|
29
|
25
|
27
|
Reasons for withdrawal
| Measure |
A - 2.5 mg Olanzapine
2.5 mg Olanzapine
olanzapine : 2.5 mg
|
B - 5 mg Olanzapine
5 mg Olanzapine
olanzapine : 5 mg
|
C - Placebo
placebo : placebo
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
29
|
25
|
27
|
Baseline Characteristics
A New Pharmacotherapy for Alcohol Dependence: Olanzapine
Baseline characteristics by cohort
| Measure |
A - 2.5 mg Olanzapine
n=43 Participants
2.5 mg Olanzapine
olanzapine : 2.5 mg
|
B - 5 mg Olanzapine
n=46 Participants
5 mg Olanzapine
olanzapine : 5 mg
|
C - Placebo
n=40 Participants
placebo : placebo
|
Total
n=129 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=99 Participants
|
46 participants
n=107 Participants
|
40 participants
n=206 Participants
|
129 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 36 weeksDrinks are measured as the number of standard alcoholic beverages consumed each day, assessed in varying lengths of time (i.e., 2 weeks, 4 weeks, 6 weeks, etc.). A standard alcoholic beverage is equivalent to: 1, 12 oz. regular beer; 1, 5 oz. glass of wine; 1, mixed drink with one1.5 oz shot; or 1, 1.5 oz shot. A drinking day is measured as any day of the week in which an alcoholic beverage is consumed. Data for drinks per drinking day is gathered using the "Time Line Follow Back" method in which participants are asked to recall their alcohol consumption day by day for a pre-defined set of time.
Outcome measures
| Measure |
A - 2.5 mg Olanzapine
n=43 Participants
2.5 mg Olanzapine
olanzapine : 2.5 mg
|
B - 5 mg Olanzapine
n=46 Participants
5 mg Olanzapine
olanzapine : 5 mg
|
C - Placebo
n=40 Participants
placebo : placebo
|
|---|---|---|---|
|
Drinks Per Drinking Day
|
8.7 Drinks per drinking day
Standard Deviation 5.3
|
8.9 Drinks per drinking day
Standard Deviation 5.1
|
9.2 Drinks per drinking day
Standard Deviation 5.4
|
Adverse Events
A - 2.5 mg Olanzapine
B - 5 mg Olanzapine
C - Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A - 2.5 mg Olanzapine
n=43 participants at risk
2.5 mg Olanzapine
olanzapine : 2.5 mg
|
B - 5 mg Olanzapine
n=46 participants at risk
5 mg Olanzapine
olanzapine : 5 mg
|
C - Placebo
n=40 participants at risk
placebo : placebo
|
|---|---|---|---|
|
General disorders
Diabetic Episode
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
|
Gastrointestinal disorders
Rectal Bleeding
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
General disorders
Orthostasis
|
2.3%
1/43 • Number of events 1
|
0.00%
0/46
|
0.00%
0/40
|
|
General disorders
Abdominal pain/palpable mass
|
0.00%
0/43
|
2.2%
1/46 • Number of events 1
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place