Trial Outcomes & Findings for Treatment Strategy for Alcohol Use Disorders in Veterans With TBI (NCT NCT01342549)

Last Updated: 2016-06-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

62 participants

Primary outcome timeframe

24 weeks

Results posted on

2016-06-09

Participant milestones
Measure	Arm 1 sodium valproate Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day	Arm 2 naltrexone Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Baseline characteristics by cohort
Measure	Arm 1 n=31 Participants sodium valproate Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day	Arm 2 n=31 Participants naltrexone Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day	Total n=62 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	31 Participants n=99 Participants	31 Participants n=107 Participants	62 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	46.71 years STANDARD_DEVIATION 9.52 • n=99 Participants	48.13 years STANDARD_DEVIATION 8.79 • n=107 Participants	47.42 years STANDARD_DEVIATION 9.17 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	31 Participants n=99 Participants	31 Participants n=107 Participants	62 Participants n=206 Participants
Region of Enrollment United States	31 participants n=99 Participants	31 participants n=107 Participants	62 participants n=206 Participants

Timeframe: 24 weeks

Outcome measures
Measure	Arm 1 n=31 Participants sodium valproate Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day	Arm 2 n=31 Participants naltrexone Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day
Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.	8.78 Weeks Standard Deviation 0.97	15.99 Weeks Standard Deviation 1.36

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Arm 1 n=31 participants at risk sodium valproate Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day	Arm 2 n=31 participants at risk naltrexone Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day
Nervous system disorders Drowsiness	38.7% 12/31 • 6 months	32.3% 10/31 • 6 months
Gastrointestinal disorders Nausea	9.7% 3/31 • 6 months	29.0% 9/31 • 6 months
Gastrointestinal disorders Diarrhea	32.3% 10/31 • 6 months	29.0% 9/31 • 6 months
Skin and subcutaneous tissue disorders Sweating	16.1% 5/31 • 6 months	32.3% 10/31 • 6 months
Gastrointestinal disorders Abdominal Pain	9.7% 3/31 • 6 months	16.1% 5/31 • 6 months

Michael E. DeBakey VAMC

Phone: 713-794-7010