Trial Outcomes & Findings for A Randomized Clinical Trial of Alcohol Care Management (NCT NCT00419315)

NCT ID: NCT00419315

Last Updated: 2015-05-12

Results Overview

This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 163 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-05-12

Participant Flow

Participant milestones

Measure	Arm 1 Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy	Arm 2 Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy
Overall Study STARTED	85	78
Overall Study COMPLETED	85	78
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Clinical Trial of Alcohol Care Management

Baseline characteristics by cohort

Measure	Arm 1 n=85 Participants Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy	Arm 2 n=78 Participants Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy	Total n=163 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	57.1 years STANDARD_DEVIATION 10.1 • n=7 Participants	56 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	73 Participants n=7 Participants	158 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants	44 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants	78 participants n=7 Participants	163 participants n=5 Participants
% Days of Heavy Drinking	54.5 % days of heavy drinking STANDARD_DEVIATION 53.8 • n=5 Participants	54.7 % days of heavy drinking STANDARD_DEVIATION 33.6 • n=7 Participants	54.6 % days of heavy drinking STANDARD_DEVIATION 44.1 • n=5 Participants
The number of Subjects Engaged in Treatment at Baseline	0 Participants engaged in treatment n=5 Participants	0 Participants engaged in treatment n=7 Participants	0 Participants engaged in treatment n=5 Participants

PRIMARY outcome

Timeframe: 6 months

This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.

Outcome measures

Measure	Arm 1 n=85 Participants Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy	Arm 2 n=78 Participants Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy
Treatment Engagement	36 percentage of participants engaged	9 percentage of participants engaged

SECONDARY outcome

Timeframe: 6 months

This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).

Outcome measures

Measure	Arm 1 n=73 Participants Care management for alcohol dependence Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy	Arm 2 n=67 Participants Usual care Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy
Percent Days of Heavy Alcohol Use	18.0 percentage of heavy drinking days Standard Deviation 30.7	25.6 percentage of heavy drinking days Standard Deviation 33.0

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Oslin

Philadelphia VA Medical Center

Phone: 215 823 5894

Email: dave.oslin@va.gov

Results disclosure agreements

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