Trial Outcomes & Findings for Modafinil for the Treatment of Alcohol Use Disorders (NCT NCT03424681)

Last Updated: 2020-05-26

Results Overview

Time to relapse, starting 7 days after treatment initiation (after medication has reached maximum tolerated dose), to heavy drinking days (\>4 standard drinks for men, \>3 standard drinks for women); abstinent is coded as 9\*7=63; dropout not included

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

over 9 weeks

Results posted on

2020-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Modafinil Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo
Overall Study STARTED	6	6
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil for the Treatment of Alcohol Use Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modafinil n=6 Participants Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo n=6 Participants Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years STANDARD_DEVIATION 12 • n=5 Participants	31 years STANDARD_DEVIATION 15 • n=7 Participants	33 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 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	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: over 9 weeks

Outcome measures

Outcome measures
Measure	Modafinil n=6 Participants Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo n=6 Participants Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo
Time to Relapse	16 days Standard Deviation 27	43 days Standard Deviation 32

SECONDARY outcome

Timeframe: Weeks 4-6

drinks per drinking day weeks 4-6

Outcome measures

Outcome measures
Measure	Modafinil n=5 Participants Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo n=6 Participants Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo
Drinks Per Drinking Day	5 drinks/drinking day Standard Deviation 6	2 drinks/drinking day Standard Deviation 2

SECONDARY outcome

Timeframe: Weeks 4-6

drinks per week weeks 4-6

Outcome measures

Outcome measures
Measure	Modafinil n=5 Participants Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo n=6 Participants Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo
Drinks Per Week	12 drinks/week Standard Deviation 13	3 drinks/week Standard Deviation 5

SECONDARY outcome

Timeframe: Weeks 4-6

percent days abstinent weeks 4-6

Outcome measures

Outcome measures
Measure	Modafinil n=5 Participants Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo n=6 Participants Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo
Percent Days Abstinent	77 percentage of days Standard Deviation 22	86 percentage of days Standard Deviation 21

Adverse Events

Modafinil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

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	Modafinil n=6 participants at risk Modafinil 300 mg by mouth each day Modafinil: Modafinil 300 mg by mouth daily	Placebo n=6 participants at risk Identical looking capsule/number of capsules by mouth each day without active medication Placebo: Placebo
Skin and subcutaneous tissue disorders rash requiring steroids	16.7% 1/6 • 10 weeks	0.00% 0/6 • 10 weeks

Additional Information

Dr. Claire Wilcox

Mind Research Network

Phone: 5052725028

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place