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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

304 participants

Primary outcome timeframe

up to 36 weeks

Results posted on

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

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

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

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 weeks

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

B - 5 mg Olanzapine

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

C - Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Kent Hutchison, Ph.D.

The Mind Reseach Network

Phone: 505-272-5028

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place