Trial Outcomes & Findings for Modafinil, Sleep, and Cognition in Cocaine Dependence (NCT NCT00582491)

NCT ID: NCT00582491

Last Updated: 2012-09-14

Results Overview

Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: After 1 Week
• Results posted on: 2012-09-14

Participant Flow

44 participants with self-identified cocaine problems responded to newspaper advertisements and passed initial telephone screening. Of those who passed the telephone screening, 29 were found to be qualified for participation after in-person screening. 21 participants entered the study and were subsequently randomized.

Participant milestones

Measure	Modafinil 400mg Modafinil 400mg orally everyday for 16 days	Placebo Placebo orally everyday for 16 days
Overall Study STARTED	11	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Modafinil 400mg Modafinil 400mg orally everyday for 16 days	Placebo Placebo orally everyday for 16 days
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Modafinil, Sleep, and Cognition in Cocaine Dependence

Baseline characteristics by cohort

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days	Total n=20 Participants Total of all reporting groups
Age Continuous	41.9 years STANDARD_DEVIATION 3.7 • n=5 Participants	43.9 years STANDARD_DEVIATION 8.4 • n=7 Participants	42.9 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 1 Week

Population: The number of participants who completed the study were analyzed

Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Total Sleep Time (Minutes)	364 Minutes Standard Deviation 75	379 Minutes Standard Deviation 38

PRIMARY outcome

Timeframe: After 2 Weeks

Population: The number of participants who completed the study were analyzed

Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Total Sleep Time (Minutes)	383 Minutes Standard Deviation 40	343 Minutes Standard Deviation 45

PRIMARY outcome

Timeframe: After 3 Weeks

Population: The number of participants who completed the study were analyzed

Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset.

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Total Sleep Time (Minutes)	373 Minutes Standard Deviation 42	315 Minutes Standard Deviation 51

PRIMARY outcome

Timeframe: After 1 Week

Population: The number of participants who completed the study were analyzed

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Time Spent in Sleep Stage 3 (Minutes)	73 Minutes Standard Deviation 33	36 Minutes Standard Deviation 33

PRIMARY outcome

Timeframe: After 2 Weeks

Population: The number of participants who completed the study were analyzed

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Time Spent in Sleep Stage 3 (Minutes)	83 Minutes Standard Deviation 29	36 Minutes Standard Deviation 26

PRIMARY outcome

Timeframe: After 3 Weeks

Population: The number of participants who completed the study were analyzed

Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Time Spent in Sleep Stage 3 (Minutes)	92 Minutes Standard Deviation 27	44 Minutes Standard Deviation 31

SECONDARY outcome

Timeframe: After 1 Week

Population: The number of participants who completed the study were analyzed.

Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Overall Sleep Quality on Visual Analog Scale (Millimeters)	63 Millimeters Standard Deviation 21	59 Millimeters Standard Deviation 23

SECONDARY outcome

Timeframe: After 2 Weeks

Population: The number of participants who completed the study were analyzed.

Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Overall Sleep Quality on Visual Analog Scale (Millimeters)	79 Millimeters Standard Deviation 16	70 Millimeters Standard Deviation 18

SECONDARY outcome

Timeframe: After 3 Weeks

Population: The number of participants who completed the study were analyzed.

Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality.

Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3.

Outcome measures

Measure	Modafinil (400mg) n=10 Participants Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 Participants Participants received a single oral placebo every morning for 16 days
Overall Sleep Quality on Visual Analog Scale (Millimeters)	81 Millimeters Standard Deviation 20	75 Millimeters Standard Deviation 16

Adverse Events

Modafinil (400mg)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Modafinil (400mg) n=10 participants at risk Participants received single oral dose of modafinil (400mg) every morning for 16 days	Placebo n=10 participants at risk Participants received a single oral placebo every morning for 16 days
Musculoskeletal and connective tissue disorders Back/Neck Pain	0.00% 0/10 • Throughout the length of the study (approximately 2 1/2 years)	10.0% 1/10 • Throughout the length of the study (approximately 2 1/2 years)
Eye disorders Conjunctivitis	0.00% 0/10 • Throughout the length of the study (approximately 2 1/2 years)	10.0% 1/10 • Throughout the length of the study (approximately 2 1/2 years)
Nervous system disorders Headache	40.0% 4/10 • Throughout the length of the study (approximately 2 1/2 years)	10.0% 1/10 • Throughout the length of the study (approximately 2 1/2 years)
Cardiac disorders Heart Palpitations	10.0% 1/10 • Throughout the length of the study (approximately 2 1/2 years)	0.00% 0/10 • Throughout the length of the study (approximately 2 1/2 years)
Gastrointestinal disorders Nausea	20.0% 2/10 • Throughout the length of the study (approximately 2 1/2 years)	0.00% 0/10 • Throughout the length of the study (approximately 2 1/2 years)

Additional Information

Peter Morgan, MD, PhD

Yale University School of Medicine

Phone: 203-974-7515

Email: Peter.Morgan@yale.edu

Results disclosure agreements

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