Trial Outcomes & Findings for Modafinil, Sleep Architecture and Cocaine Relapse (NCT NCT01137396)

NCT ID: NCT01137396

Last Updated: 2016-04-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 114 participants
• Primary outcome timeframe: 3x/week
• Results posted on: 2016-04-27

Participant Flow

Participant milestones

Measure	Modafinil Modafinil: Modafinil 400mg PO QDaily following up-titration for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo Placebo: Placebo medication Qdaily for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
Overall Study STARTED	30	27
Overall Study COMPLETED	22	25
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil, Sleep Architecture and Cocaine Relapse

Baseline characteristics by cohort

Measure	Modafinil n=30 Participants Modafinil: Modafinil 400mg PO QDaily following up-titration for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo n=27 Participants Placebo: Placebo medication Qdaily for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Total n=57 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 7 • n=5 Participants	44 years STANDARD_DEVIATION 7 • n=7 Participants	43 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3x/week

Outcome measures

Measure	Modafinil n=22 Participants Modafinil: Modafinil 400mg PO QDaily following up-titration for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo n=25 Participants Placebo: Placebo medication Qdaily for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
%Cocaine Free Urines	52 percent Standard Error 9	26 percent Standard Error 7

SECONDARY outcome

Timeframe: change from week 1 to week 2 of inpatient treatment

Outcome measures

Measure	Modafinil n=22 Participants Modafinil: Modafinil 400mg PO QDaily following up-titration for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo n=25 Participants Placebo: Placebo medication Qdaily for \~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
Change in N3 (Slow-wave) Sleep Time	16 minutes Standard Error 4	-2.5 minutes Standard Error 4

Adverse Events

Modafinil

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Peter Morgan

Yale University

Phone: 203-974-7560

Email: peter.morgan@yale.edu

Results disclosure agreements

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